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Greenstone Biosciences Receives NIH R61 Grant to Advance Cardiac Fibrosis Therapeutics for Duchenne Muscular Dystrophy

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PALO ALTO, Calif.–(BUSINESS WIRE)– #BioPharma–Greenstone Biosciences, a biotechnology company advancing New Approach Methodologies (NAMs) for drug discovery, today announced that it has received a Catalyze R61 award from the National Heart, Lung, and Blood Institute (NHLBI), a component of the National Institutes of Health (NIH). The award funds a research program to discover novel drug candidates for myocardial fibrosis and dilated cardiomyopathy in Duchenne muscular dystrophy (DMD). DMD is a rare genet

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Profound Medical Reports Second Quarter 2026 Financial Results

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– Operating expenses decline 16%, helping drive a 39% improvement in net loss – – Approximately $3.1 million of TULSA revenue recognition shifts into early Q3 due to shipment timing – – Strong clinical, commercial and reimbursement momentum continues – – Company reiterates full-year 2026 revenue guidance – – Announces first employer owned health plans to list the TULSA Procedure™ as a covered service – TORONTO, Aug. 06, 2026 (GLOBE NEWSWIRE) — Profound Medical Corp. (NASDAQ:PROF; TSX:PRN) (“Profound” or the “Company”), a commercial-stage medical device company that develops and markets innovative interventional MRI (“iMRI”) procedures, today announced financial results for the second quarter ended June 30, 2026. Unless specified otherwise, all amounts in this press release are expressed in U.S. dollars and are presented in accordance with U.S. generally accepted accounting principles (U.S. GAAP).  “Commercial momentum continued to accelerate during the second quarter,” said Arun Menawat, Profound’s CEO and Chairman. “We received over $7.0 million in new purchase orders, a new quarterly record. Approximately $2.5 million of those orders were recognized as revenue during the quarter, while approximately $3.1 million was shipped in July and will be recognized in the third quarter. The shipment timing reflected a temporary logistics issue—not customer demand—and, absent the timing difference, second quarter revenue would have increased approximately 153% year-over-year. The logistics issue has since been resolved. Beyond top-line growth, our business model continued to demonstrate meaningful operating leverage. Gross margin remained above our long-term target of 70%, operating expenses declined 16%, and net loss improved by 39% year-over-year. Momentum has continued into the third quarter, including another monthly record for new order activity in July and exceptional physician engagement at SRS2026 that generated more than 160 qualified commercial opportunities over just four days. Based on continued payer coverage expansion, growing clinical validation, and a strengthening sales pipeline, we believe we are now in the strongest commercial position in the Company’s history. Based on this momentum and our improved visibility into the second half of the year, we are reiterating the $25.0 million bar we previously set for 2026 total revenue.” Business Highlights Clinical Momentum The post-market CAPTAIN Level 1 randomized clinical data continued to demonstrate statistically significant advantages of the TULSA Procedure™ over robotic radical prostatectomy, with new penile length preservation data presented in July 2026.Physician awareness of, and engagement with, the TULSA Procedure continued to expand through presentations at the 2026 meetings of the Society of Interventional Radiology (SIR), the American Urological Association (AUA), and the Society of Robotic Surgery (SRS). Reimbursement Expansion Payer coverage expanded by approximately 18.3 million covered lives during the second quarter, substantially broadening patient access to the TULSA Procedure. Most of the newly covered lives came through state Medicaid and managed Medicaid (Ambetter) programs.Today, Profound is pleased to announce that the Johns Hopkins Employee Health Plan and the Prime Healthcare Employee Health Plan, covering more than 50,000 and 55,000 employees, medical staff and family members, respectively, have become the first employer owned health plans to list the TULSA Procedure as a covered service. Commercial Execution & Adoption Profound’s TULSA-PRO® installed base increased to 84 at the end of Q2-2026.Profound estimates that the current aggregate total dollar value of its qualified sales pipeline (defined as within one of the “Verify, Negotiate and Contracting” stages) for TULSA-PRO and Sonalleve® is approximately $70.0 million.* Continuing Innovation Profound also launched an initiative to explore the potential of integrating PSMA PET molecular imaging technologies with the TULSA Procedure to support intention-to-treat decisions and patient monitoring. * There can be no assurance given with respect to the extent and/or timing of the Company’s qualified sales pipeline resulting in recognized revenue. Q2-2026 Clinical Utilization Trends Physicians continued to utilize the TULSA Procedure’s customizable prostate tissue ablation capabilities in the second quarter of 2026: Prostate Condition Ablation of malignant prostate tissueAblation of malignant and benign enlarged prostate tissueAblation of recurrent malignant prostate tissueAblation of benign enlarged prostate tissue71%(12% GG1, 58% GG2, 21% GG3, 9% GG4&5)14%11%4%     Regional Ablation Whole-glandSub-total but more than half the glandHemi-ablationFocal therapy43%24%21%12%     Prostate Size 100 cc8%39%31%17%5%      TULSA INDEX20 Introduced by the Company in the first quarter of 2026, the following supplemental ‘same-store’ TULSA Procedure volume analysis is designed to track a fixed cohort (i.e. without any changes or substitutions) of 20 active commercial TULSA-PRO sites over time. The TULSA INDEX20 includes a representative variety of providers, including teaching hospitals and private-pay practices, all of which have been performing TULSA Procedures for at least 12 months. Geographically, 80% of the index sites are in the U.S. and 20% are international. TULSA INDEX20Q2-2025Q3-2025Q4-2025Q1-2026Q2-2026# TULSA Sites2020202020Average Procedures/Quarter8.28.610.311.310.0Average Procedures Annualized32.834.441.245.240.0Quarter-Over-Quarter Sequential Growth15%5%20%10%(12%)H1-2026 Over H1-2025 Growth   39%Quarterly Year-Over-Year Growth    22%       Summary Second Quarter 2026 Results For the quarter ended June 30, 2026, Profound recorded total revenue of approximately $2.5 million, up 12% year-over-year, including $1.6 million of recurring non-capital revenue from single-use devices and services associated with extended warranties, and $871,000 from capital equipment sales. Approximately $3.1 million of TULSA product shipments originally anticipated in the final week of June were completed in July. The timing affected only the period of revenue recognition and did not reflect any change in customer demand or order activity. Excluding this shipment timing, second quarter revenue would have been approximately $5.6 million, representing 153% year-over-year growth. Gross margin expanded to 78% in Q2-2026 from 73% in the prior-year period, reflecting a favorable product mix, including multiple capital system sales that were previously under operating leases to customers. Operating expenses declined 16% year over year to approximately $13.0 million, primarily reflecting lower personnel, commercial, travel, insurance and CAPTAIN clinical trial costs following completion of enrollment. These reductions were partially offset by higher R&D investments focused on product cost reduction, quality improvements and manufacturing efficiencies. Second quarter 2026 net loss was approximately $9.5 million, or $0.26 per common share, a 39% improvement from a net loss of approximately $15.7 million, or $0.52 per common share, in the three months ended June 30, 2025. Liquidity and Outstanding Share Capital As at June 30, 2026, Profound had cash of approximately $38.3 million. As at August 6, 2026, Profound had 36,532,594 common shares issued and outstanding. For complete financial results, please see Profound’s filings, which will be made available under Profound’s profile at www.sedarplus.com, www.sec.gov and on Profound’s website under “SEC & SEDAR+ Filings.” Full Year 2026 Financial Outlook Based on record order activity, continued expansion of its commercial pipeline and improved visibility into second-half shipments, Profound continues to project total revenue for full-year 2026 to be approximately $25.0 million, which represents 56% growth compared to its prior year revenue. The Company also continues to expect full year 2026 gross margin to be 70% or higher. Conference Call Details Profound is pleased to invite all interested parties to participate in a conference call today at 4:30 pm ET during which time the results will be discussed. To participate in the conference call by telephone, please pre-register via this link to receive the dial-in number and your unique PIN. The call will also be broadcast live and archived on Profound’s website in the Investors section here. About Profound Medical Corp. Profound is a commercial-stage medical device company and an innovator in interventional MRI (iMRI) procedures.  The company’s flagship platform, TULSA-PRO®, enables MRI-guided, incision-free prostate ablation. Physicians use the TULSA Procedure™ to see, ablate, and confirm therapy in real time, supporting personalized treatment strategies across the continuum of prostate care—from whole-gland to subtotal, hemi, multifocal, and focal treatment. This approach enables individualized care using prostate tissue ablation, while minimizing the potential of the side effects that are typically associated with surgery or radiation, such as urinary incontinence and/or erectile dysfunction. Profound also commercializes Sonalleve®, an MRI-guided therapy that provides a non-surgical treatment option for pain palliation of bone metastases, desmoid tumors, and osteoid osteoma, as well as for common gynecologic conditions including uterine fibroids and adenomyosis. Sonalleve delivers targeted therapy with no incisions, no blood loss during the procedure, no overnight hospital stay, and faster recovery — and, in gynecologic applications, enables uterine-sparing treatment that may help preserve fertility. Profound is also exploring additional clinical applications for Sonalleve, including non-invasive ablation of abdominal cancers and hyperthermia-based cancer therapies. Profound Medical’s technologies are approved across major global markets. TULSA-PRO is cleared by the FDA in the United States for transurethral ultrasound ablation (TULSA) of prostate tissue. In addition, TULSA-PRO is cleared for use in various jurisdictions including Europe, Canada, Saudi Arabia, India, Australia/New Zealand, and the UAE. Sonalleve is approved by the FDA as HDE in the United States for the treatment of osteoid osteomas in the extremities. Sonalleve is also cleared or approved in the Europe, Canada, China, and Saudi Arabia. Through real-time MRI guidance and data-driven innovation, Profound is advancing the future of MRI-guided therapy — expanding access to precise, personalized, and incision-free treatment options worldwide. Forward-Looking Statements This release includes forward-looking statements regarding Profound and its business which may include, but is not limited to, the expectations regarding the efficacy of Profound’s technologies for disease conditions requiring MR-Guided ablation procedures for prostate, uterine fibroids, adenomyosis, palliative pain treatment, desmoid tumors, and osteoid osteoma; the extent and timing of Profound’s completion of TULSA-PRO® and Sonalleve® system sales from its qualified sales pipeline; Profound’s expectations for future revenues/financial results; and the success of Profound’s commercialization strategy and activities for TULSA-PRO and Sonalleve. Often, but not always, forward-looking statements can be identified by the use of words such as “plans”, “is expected”, “expects”, “scheduled”, “intends”, “contemplates”, “anticipates”, “believes”, “proposes” or variations (including negative variations) of such words and phrases, or state that certain actions, events or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved. Such statements are based on the current expectations of the management of Profound. The forward-looking events and circumstances discussed in this release, may not occur by certain specified dates or at all and could differ materially as a result of known and unknown risk factors and uncertainties affecting the Company, including risks regarding the medical device industry, regulatory approvals, reimbursement, economic factors, the equity markets generally and risks associated with growth and competition. Although Profound has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. No forward-looking statement can be guaranteed. Other factors and risks that may cause actual results to differ materially from those set out in the forward-looking statements are described in Profound’s Annual Report on Form 10-K and other filings made with U.S. and Canadian securities regulators, available at www.sedarplus.com and www.sec.gov. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and Profound undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise, other than as required by law. Financial Outlook This press release contains a financial outlook within the meaning of applicable securities laws. The financial outlook has been prepared by management of the Company to provide an outlook for the Company’s forecasted revenue for the 12 months to be ended December 31, 2026, and may not be appropriate for any other purpose. The financial outlook has been prepared based on a number of assumptions, including the assumptions discussed under the heading “Forward-Looking Statements” herein. The actual results of the Company’s operations for any period may vary from the amounts set forth in these projections, and such variations may be material. The Company and its management believe that the financial outlook has been prepared on a reasonable basis. However, because this information is highly subjective and subject to numerous risks, including the risks discussed under the heading “Forward-Looking Statements” herein, it should not be relied on as necessarily indicative of future results. For further information, please contact: Stephen KilmerInvestor Relationsskilmer@profoundmedical.com  T: 647.872.4849 Profound Medical Corp.CONDENSED CONSOLIDATED BALANCE SHEETS (USD in thousands, except per share data) (unaudited)  June 30, 2026$ December 31, 2025$    Assets     Current assets:  Cash38,271 59,723 Trade and other receivables, net9,614 7,200 Inventory10,456 8,238 Prepaid expenses and deposits523 928 Total current assets58,864 76,089    Trade and other receivables, net- 300 Property and equipment, net556 698 Intangible assets, net121 138 Right-of-use assets, net2,763 184 Deferred tax assets, net81 66 Total assets62,385 77,475    Liabilities     Current liabilities:  Accounts payable955 1,563 Accrued expenses and other current liabilities3,127 3,815 Deferred revenue342 445 Long-term debt4,507 – Lease liabilities119 213 Income tax payable63 39 Total current liabilities9,113 6,075    Deferred revenue618 388 Long-term debt- 4,499 Lease liabilities2,754 – Other non-current liabilities92 79 Total liabilities12,577 11,041    Shareholders’ equity     Common shares, no par value, unlimited shares authorized, 36,532,594 and 36,293,640 issued and outstanding at June 30, 2026 and December 31, 2025, respectively325,383 323,839 Additional paid-in capital25,688 25,310 Accumulated other comprehensive income3,070 5,025 Accumulated deficit(304,333)(287,740)Total shareholders’ equity49,808 66,434    Total liabilities and shareholders’ equity62,385 77,475       Profound Medical Corp.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME(USD in thousands, except per share data) (unaudited)  Three Months EndedJune 30, Six Months EndedJune 30,  2026$ 2025$ 2026$ 2025$      Revenue    Recurring – non-capital1,612 1,561 4,086 3,362 Capital equipment871 650 3,734 1,470  2,483 2,211 7,820 4,832 Cost of sales536 593 2,041 1,361 Gross profit1,947 1,618 5,779 3,471      Operating expenses    Research and development5,654 6,098 10,916 10,906 Selling, general and administrative7,359 9,326 13,950 17,537 Total operating expenses13,013 15,424 24,866 28,443      Operating loss11,066 13,806 19,087 24,972      Other (income) expenses    Net finance income(336)(343)(713)(788)Net foreign exchange (gain) loss(1,245)2,168 (1,861)2,130 Total other (income) expenses(1,581)1,825 (2,574)1,342      Net loss before income taxes9,485 15,631 16,513 26,314      Income tax expense68 78 95 119 Deferred tax recovery(13)(14)(15)(14)Total income tax expense55 64 80 105      Net loss attributed to shareholders for the period9,540 15,695 16,593 26,419      Other comprehensive (income) loss    Item that may be reclassified to (income) loss    Foreign currency translation adjustment950 (2,713)1,955 (2,816)     Net loss and other comprehensive loss for the period10,490 12,982 18,548 23,603      Loss per share    Basic and diluted net loss per common share0.26 0.52 0.46 0.88 Basic and diluted weighted average common shares outstanding36,350,665 30,053,142 36,324,393 30,055,047           Profound Medical Corp.CONDENSED CONSOLIDATED STATEMENTS OF CASHFLOWS(USD in thousands, except per share data) (unaudited)   Six Months Ended June 30,  2026$ 2025$    Cash flows from operating activities  Net loss for the period(16,593)(26,419)Adjustments to reconcile net loss to net cash provided by operating activities:  Depreciation of property and equipment219 218 Amortization of intangible assets16 86 Non-cash lease expense adjustment99 (19)Share-based compensation1,922 2,440 Interest and accretion expense9 51 Changes in operating assets and liabilities:  Trade and other receivables(2,473)2,449 Inventory(2,686)(2,723)Prepaid expenses and deposits384 1,042 Accounts payable, accrued expenses and other liabilities(991)545 Deferred revenue164 317 Income taxes payable27 – Deferred tax assets(18)(14)Net cash used in operating activities(19,921)(22,027)   Cash flows from financing activities  Repayments of long-term debt- (290)Net cash provided by (used in) financing activities- (290)   Net increase (decrease) in cash(19,921)(22,317)Effect of exchange rate changes on cash(1,531)2,600 Cash, beginning of period59,723 54,912 Cash, end of period38,271 35,195 

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CVRx Reports Second Quarter 2026 Financial and Operating Results

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MINNEAPOLIS, Aug. 06, 2026 (GLOBE NEWSWIRE) — CVRx, Inc. (NASDAQ: CVRX) (“CVRx”), a commercial-stage medical device company focused on developing, manufacturing and commercializing innovative neuromodulation solutions for patients with cardiovascular diseases, today announced its financial and operating results for the second quarter of 2026. Recent Highlights Total revenue for the second quarter of 2026 was $15.7 million, an increase of approximately 16% over the prior year quarterU.S. revenue for the second quarter of 2026 was $14.8 million, an increase of 21% over the prior year quarterActive implanting centers in the U.S. grew to 258 as of June 30, 2026, as compared to 240 as of June 30, 2025Humana issued a Medicare Advantage coverage policy, effective May 1, 2026 for Barostim therapy, which is the first coverage policy of its kind for Barostim “We are pleased with the strong revenue growth and margin performance in the second quarter along with the reimbursement progress we made, including the new Medicare Advantage coverage policy from Humana. However, we are not satisfied with our updated outlook for the balance of the year, driven by fewer sales territories than anticipated, lower sales force productivity and a prolonged challenge with one of our largest payers,” said Kevin Hykes, President and Chief Executive Officer of CVRx. “We are taking direct action to address these headwinds, and our confidence in the long-term fundamentals of this business remains high, supported by strong growth observed in our most stable regions and encouraging early progress on the BENEFIT-HF trial and our broader clinical and reimbursement strategies.” Second Quarter 2026 Financial and Operating Results Revenue was $15.7 million for the three months ended June 30, 2026, an increase of $2.1 million, or 16%, over the three months ended June 30, 2025. Revenue generated in the U.S. was $14.8 million for the three months ended June 30, 2026, an increase of $2.5 million, or 21%, over the three months ended June 30, 2025. Revenue units in the U.S. totaled 466 and 391 for the three months ended June 30, 2026 and 2025, respectively. The increases were primarily driven by continued growth in the U.S. HF business as a result of the expansion into new sales territories, new accounts, and increased physician and patient awareness of Barostim. As of June 30, 2026, the Company had a total of 258 active implanting centers in the U.S., as compared to 240 as of June 30, 2025. Active implanting centers are customers that have completed at least one commercial HF implant in the last 12 months. As of June 30, 2026, the number of sales territories in the U.S. is 56 as compared to 47 sales territories as of June 30, 2025. Revenue generated in Europe was $0.9 million for the three months ended June 30, 2026, a decrease of $0.4 million, or 31%, compared to the three months ended June 30, 2025. Total revenue units in Europe decreased to 40 for the three months ended June 30, 2026, from 61 in the prior year period. The number of sales territories in Europe remained consistent at five as of June 30, 2026. Gross profit was $13.7 million for the three months ended June 30, 2026, an increase of $2.3 million, or 20%, over the three months ended June 30, 2025. Gross margin was 87% and 84% for the three months ended June 30, 2026 and June 30, 2025, respectively. R&D expenses increased $0.7 million, or 27%, to $3.1 million for the three months ended June 30, 2026, compared to the three months ended June 30, 2025. This change was driven by a $0.6 million increase in headcount expenses and a $0.1 million increase in clinical trial expenses. SG&A expenses increased $0.3 million, or 1%, to $23.6 million for the three months ended June 30, 2026, compared to the three months ended June 30, 2025. This change was primarily driven by a $0.7 million increase in non-cash stock-based compensation expenses and a $0.5 million increase in legal expenses, partially offset by a $0.6 million decrease in advertising expenses and a $0.3 million decrease in travel expenses. Interest expense increased $0.1 million for the three months ended June 30, 2026, compared to the three months ended June 30, 2025, driven by interest expense on the increased borrowings under the term loan agreement with Innovatus Capital Partners. Other income, net was $0.6 million and $1.1 million for the three months ended June 30, 2026 and 2025, respectively. These balances consisted of interest income on our interest-bearing accounts. The decrease was primarily driven by the lower cash balance. Net loss was $14.0 million, or $0.53 per share, for the three months ended June 30, 2026, compared to a net loss of $14.7 million, or $0.57 per share, for the three months ended June 30, 2025. Net loss per share was based on 26.5 million weighted average shares outstanding for three months ended June 30, 2026 and 26.1 million weighted average shares outstanding for the three months ended June 30, 2025. As of June 30, 2026, cash and cash equivalents were $64.6 million. Net cash used in operating and investing activities was $8.9 million for the three months ended June 30, 2026, compared to $8.0 million for the three months ended June 30, 2025. Humana Medicare Advantage Coverage Policy In May 2026, Humana issued a Medicare Advantage coverage policy for Barostim therapy, effective May 1, 2026. Humana, a national health insurance company with the second largest Medicare Advantage program in the U.S., provides coverage to approximately 5.2 million Medicare Advantage members across 46 states. The policy covers Barostim for patients meeting its current FDA-approved indication as well as patients enrolled in the BENEFIT-HF trial. This is now the third significant reimbursement development for Barostim this year, following the transition to Category I CPT codes and CMS approval of Category B IDE coverage for BENEFIT-HF patients, each of which took effect in the first quarter of 2026. Business Outlook For the full year of 2026, the Company now expects: Total revenue between $58.0 million and $60.0 million;Gross margin between 86% and 87%;Operating expenses between $99.0 million and $101.0 million. For the third quarter of 2026, the Company expects to report total revenue between $13.5 million and $14.5 million. Webcast and Conference Call Information The Company will host a conference call to review its results at 4:30 p.m. Eastern Time today. A live webcast of the investor conference call will be available online at the investor relations page of the Company’s website at ir.cvrx.com. To listen to the conference call on your telephone, please dial 1-877-704-4453 for U.S. callers, or 1-201-389-0920 for international callers, approximately ten minutes prior to the start time. About CVRx, Inc. CVRx is a commercial-stage medical device company focused on developing, manufacturing and commercializing innovative neuromodulation solutions for patients with cardiovascular diseases. Barostim™ is the first medical technology approved by FDA that uses neuromodulation to improve the symptoms of patients with heart failure. Barostim is an implantable device that delivers electrical pulses to baroreceptors located in the wall of the carotid artery. The therapy is designed to restore balance to the autonomic nervous system and thereby reduce the symptoms of heart failure. Barostim received the FDA Breakthrough Device designation and is FDA-approved for use in heart failure patients in the U.S. It has been certified as compliant with the EU Medical Device Regulation (MDR) and holds CE Mark approval for heart failure and resistant hypertension in the European Economic Area. To learn more about Barostim, visit www.cvrx.com. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts are forward-looking statements, including statements regarding our future financial performance (including our financial guidance regarding full year and third quarter 2026 results), our anticipated growth strategies (including statements regarding the expected timing, enrollment, scope and outcomes of the BENEFIT-HF clinical trial, potential expansion of the Barostim indication, and anticipated benefits of Barostim therapy), anticipated trends in our industry, our business prospects and our opportunities. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “outlook,” “guidance,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. The forward-looking statements in this press release are only predictions and are based largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition, and results of operations. These forward-looking statements speak only as of the date of this press release and are subject to a number of known and unknown risks, uncertainties and assumptions, including, but not limited to, our expectations regarding enrollment in BENEFIT-HF and the resulting impact on our addressable market; our history of significant losses, which we expect to continue; our limited history operating as a commercial company and our dependence on a single product, Barostim; our limited commercial sales experience marketing and selling Barostim; our ability to continue demonstrating to physicians and patients the merits of our Barostim; any failure by third-party payors to provide adequate coverage and reimbursement for the use of Barostim; our competitors’ success in developing and marketing products that are safer, more effective, less costly, easier to use or otherwise more attractive than Barostim; any failure to receive access to hospitals; our dependence upon third-party manufacturers and suppliers, and in some cases a limited number of suppliers; a pandemic, epidemic or outbreak of an infectious disease in the U.S. or worldwide; product liability claims; future lawsuits to protect or enforce our intellectual property, which could be expensive, time consuming and ultimately unsuccessful; any failure to retain our key executives or recruit and hire new employees; impacts on adoption and regulatory approvals resulting from additional long-term clinical data about our product, including those resulting from the BENEFIT-HF trial; and other important factors that could cause actual results, performance or achievements to differ materially from those that are found in “Part I, Item 1A. Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2025, as such factors may be updated from time to time in our other filings with the Securities and Exchange Commission. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. Investor Contact:Mark Klausner or Mike VallieICR Healthcare443-213-0501ir@cvrx.com Media Contact:Emily Meyers CVRx, Inc. 763-416-2853emeyers@cvrx.com  CVRx, INC.Condensed Consolidated Balance Sheets(In thousands, except share and per share data)(Unaudited)  June 30,2026 December 31,2025Assets   Current assets:   Cash and cash equivalents$64,586  $75,708 Accounts receivable, net of allowances of $869 and $871, respectively 9,401   10,665 Inventory 13,028   12,205 Prepaid expenses and other current assets 2,473   3,069 Total current assets 89,488   101,647 Property and equipment, net 2,061   2,243 Operating lease right-of-use asset 708   878 Other non-current assets 26   26 Total assets$92,283  $104,794 Liabilities and Stockholders’ Equity   Current liabilities:   Accounts payable$3,874  $3,833 Accrued expenses 7,250   9,484 Total current liabilities 11,124   13,317 Long-term debt 58,571   49,514 Operating lease liability, non-current portion 448   638 Other long-term liabilities 2,187   2,001 Total liabilities 72,330   65,470 Commitments and contingencies   Stockholders’ equity:   Common stock, $0.01 par value, 200,000,000 authorized as of June 30, 2026 and December 31, 2025; 26,641,597 and 26,311,607 shares issued and outstanding as of June 30, 2026 and December 31, 2025, respectively 266   263 Additional paid-in capital 637,707   629,916 Accumulated deficit (617,816)  (590,652)Accumulated other comprehensive loss (204)  (203)Total stockholders’ equity 19,953   39,324 Total liabilities and stockholders’ equity$92,283  $104,794   CVRx, INC.Condensed Consolidated Statements of Operations and Comprehensive Loss(In thousands, except share and per share data)(Unaudited)  Three months endedJune 30, Six months endedJune 30,  2026   2025   2026   2025 Revenue$15,705  $13,589  $30,474  $25,937 Cost of goods sold 1,981   2,139   3,869   4,175 Gross profit 13,724   11,450   26,605   21,762 Operating expenses:       Research and development 3,130   2,469   6,214   4,986 Selling, general and administrative 23,617   23,357   45,575   44,589 Total operating expenses 26,747   25,826   51,789   49,575 Loss from operations (13,023)  (14,376)  (25,184)  (27,813)Interest expense (1,578)  (1,473)  (3,129)  (2,930)Other income, net 560   1,110   1,153   2,233 Loss before income taxes (14,041)  (14,739)  (27,160)  (28,510)Benefit (provision) for income taxes (3)  3   (4)  8 Net loss (14,044)  (14,736)  (27,164)  (28,502)Cumulative translation adjustment —   3   —   3 Comprehensive loss$(14,044) $(14,733) $(27,164) $(28,499)Net loss per share, basic and diluted$(0.53) $(0.57) $(1.03) $(1.10)Weighted-average common shares used to compute net loss per share, basic and diluted 26,515,442   26,071,316   26,435,958   25,974,229 

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Tectonic Therapeutic Announces Second Quarter 2026 Financial Results and Recent Business Highlights

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Enrollment completed in TX45 APEX Phase 2 clinical trial in patients with pulmonary hypertension associated with heart failure with preserved ejection fraction (“PH-HFpEF”) with topline results anticipated in early Q1 2027TX45 APEX Phase 2 clinical trial Independent Data Monitoring Committee (“IDMC”) met in July 2026 and recommended continuation of the study without modificationTX2100, a potential treatment for Hereditary Hemorrhagic Telangiectasia (“HHT”), completed dosing of the six single dose healthy volunteer cohorts in the Phase 1a clinical trial, with topline results anticipated by end of Q3 2026Cash and cash equivalents were $227.1 million as of June 30, 2026, including approximately $11.7 million in net proceeds raised from an at-the-market offering for the three months ended June 30, 2026, is expected to provide cash runway into Q1 2029 WATERTOWN, Mass., Aug. 06, 2026 (GLOBE NEWSWIRE) — Tectonic Therapeutic, Inc. (NASDAQ: TECX) (“Tectonic” or the “Company”), a clinical stage biotechnology company focused on the discovery and development of therapeutic proteins and antibodies that modulate the activity of G-protein coupled receptors (GPCRs), today announced financial results for the second quarter ended June 30, 2026, and provided an overview of recent business highlights. “In the second quarter, we completed enrollment in our global APEX Phase 2 trial in PH-HFpEF, a critical milestone for TX45, and we look forward to topline results in early Q1 2027,” said Alise Reicin, M.D., President and Chief Executive Officer of Tectonic Therapeutic. “We also completed dosing of the single dose cohorts in the TX2100 Phase 1a clinical trial in healthy volunteers. Subject to favorable safety, tolerability and pharmacokinetic results, we plan to advance TX2100 into a Phase 1b trial in patients with hematologic-support dependent HHT and a Phase 2 trial in moderate to severe HHT patients, bringing us one step closer to a first-in-class therapy for a disease with no approved treatments.” Recent Business Highlights Completed Enrollment of TX45 APEX Phase 2 Clinical Trial in PH-HFpEF Patients: In June 2026, the Company completed enrollment for the APEX trial, a global, randomized, placebo-controlled 24-week Phase 2 clinical trial evaluating the safety and efficacy of TX45 in patients with PH-HFpEF. In July 2026, the Independent Data Monitoring Committee (“IDMC”) met to review unblinded safety and efficacy data from the TX45 APEX Phase 2 clinical trial, including approximately 80% of the expected patient exposure. The IDMC recommended the continuation of the trial without modification. The trial was designed to include an enriched population of a more severe disease subtype of combined pre- and post-capillary pulmonary hypertension (“CpcPH”) patients with a pulmonary vascular resistance (“PVR”) >3 Wood Units (“WU”) at baseline. The APEX Phase 2 clinical trial enrolled a total of 191 patients across 14 countries of which 137 patients were enrolled with CpcPH and PVR >3 WU at baseline, consistent with the goal for this patient population to represent approximately 70% of the overall patients enrolled in APEX. The mean baseline PVR in the overall patient population and the subset of patients with CpcPH and PVR >3 WU was 4.2 WU¹ and 5.2 WU¹, respectively. Completed Dosing of Single Dose Cohorts in Phase 1a Clinical Trial of TX2100 in Healthy Volunteers: In July 2026, the Company completed dosing of the six single dose cohorts in the Phase 1a clinical trial of TX2100 in healthy volunteers. The randomized, placebo-controlled, double-blind, single ascending-dose trial is intended to characterize safety and tolerability, with pharmacokinetics assessed as a secondary endpoint. TX2100 is a VHH-Fc antagonist of the APJ (apelin) receptor, a GPCR involved in pro-angiogenic signaling, and is being developed as a potential treatment for Hereditary Hemorrhagic Telangiectasia (HHT). Upcoming Milestones TX2100 Phase 1a Topline Results Expected by End of Q3 2026 with Phase 2 Planned in Early 2027: The Company expects to report topline results for the TX2100 Phase 1a clinical trial in healthy volunteers by the end of Q3 2026, with detailed data planned to be subsequently presented at a scientific meeting. Subject to favorable safety, tolerability and pharmacokinetic results, Tectonic plans to advance TX2100 into an open-label Phase 1b clinical trial in patients with hematologic-support dependent HHT and a placebo-controlled, Phase 2 clinical trial in moderate-to-severe HHT patients, with endpoints expected to include epistaxis, hemoglobin, hematologic support, and other endpoints relevant to HHT. Phase 1b and Phase 2 trials are planned to run in parallel, with the Phase 2 trial anticipated to begin in early 2027.TX45 APEX Phase 2 Trial Ongoing with Topline Results Expected Early Q1 2027: The global, randomized, placebo-controlled 24-week APEX Phase 2 trial is ongoing, evaluating subcutaneous TX45 in patients with PH-HFpEF, including an enriched population with combined pre- and post-capillary pulmonary hypertension (CpcPH). The primary endpoint is change in pulmonary vascular resistance (PVR) from baseline in the CpcPH subgroup (PVR ≥3 Wood Units). APEX patient enrollment is complete with topline results expected early Q1 2027. Overview of Financial and Operating Results Cash Position: As of June 30, 2026, cash and cash equivalents were $227.1 million, compared to $236.9 million as of March 31, 2026. Tectonic anticipates that, based on current operating assumptions, its current cash and cash equivalents will provide a cash runway into Q1 2029, including through the Phase 2 topline readouts of TX45 in PH-HFpEF and PH-ILD, and through significant clinical milestones in the TX2100 development program.Research and Development Expenses: Research and development expenses were $18.0 million for the three months ended June 30, 2026, as compared to $17.2 million for the three months ended June 30, 2025. The increase was primarily the result of contract research and contract development and manufacturing organizations costs related to the ongoing Phase 2 clinical trials of TX45 and employee-related expenses due to an increase in non-cash, stock-based compensation expense and increase in headcount.General and Administrative Expenses: General and administrative expenses were $6.2 million for the three months ended June 30, 2026, as compared to $5.2 million for the three months ended June 30, 2025. The increase was primarily the result of higher employee-related expenses driven by higher non-cash, stock-based compensation.Net Loss: For the three months ended June 30, 2026, the Company had a net loss of $22.3 million compared to a net loss of $20.0 million for the three months ended June 30, 2025. ¹ Baseline characteristics are preliminary and subjective to change. About Group 2 Pulmonary Hypertension in HFpEFThe World Health Organization has defined 5 groups of pulmonary hypertension (“PH”). Tectonic is focused on the Group 2 subtype, a condition that develops due to left-sided heart disease, specifically PH-HFpEF. In patients with PH-HFpEF, chronic heart failure leads to increased blood pressure in the pulmonary arteries, exerting severe strain on the right side of the heart, which adapts poorly to the increased pressure. This increased pulmonary pressure gradually causes worsening exercise capacity, shortness of breath and right-sided heart failure, which can lead to death. PH-HFpEF is further segmented based on pulmonary hemodynamics into Isolated, post-capillary PH (“IpcPH”) and CpcPH. CpcPH is more severe, accounts for about one third to one half of the 1.4 million PH-HFpEF patients in the U.S. and is characterized by additional, abnormal changes to the pulmonary vasculature, leading to an increase in PVR. Although several Group 1 PH (Pulmonary Arterial Hypertension, “PAH”) medications have been explored in Group 2 PH, to date, no medications have been approved for its treatment. About Group 3 Pulmonary Hypertension and PH-ILDGroup 3 is PH due to chronic lung disease and Tectonic is focused on a Group 3 subtype, called PH-ILD where PH develops in patients who have ILD. ILD is a group of rare conditions causing inflammation and scarring in the lungs. It is believed that a combination of factors leads to the formation of PH-ILD, including lung fibrosis, chronic hypoxia, vascular remodeling and other factors that lead to worsening exercise capacity. PH-ILD has worse survival than ILD without PH. There are currently two approved treatments for PH-ILD, both of which contain the active ingredient treprostinil administered via nebulizer or dry powder inhaler. About TX45, a long-acting Fc-relaxin fusion proteinTX45 is an Fc-relaxin fusion protein with optimized pharmacokinetics and biophysical properties that activates the RXFP1 receptor, the G-protein coupled receptor target of the hormone relaxin. Relaxin is an endogenous protein, expressed at low levels in both men and women that is a pulmonary and systemic vasodilator with lusitropic, anti-fibrotic and anti-inflammatory activity. In normal human physiology, relaxin is upregulated during pregnancy where it exerts vasodilative effects, reduces systemic and pulmonary vascular resistance and increases cardiac output to accommodate the increased demand for oxygen and nutrients from the developing fetus. Relaxin also exerts anti-fibrotic effects on pelvic ligaments to facilitate delivery of the baby. About Hereditary Hemorrhagic Telangiectasia (HHT)HHT is a rare, inherited vascular disorder affecting an estimated 75,000 people in the United States. HHT is the second most common inherited bleeding disorder and a disease for which there are currently no approved therapies. It is characterized by fragile, abnormal blood vessels that lead to recurrent bleeding, which can reduce quality of life, result in emergency room visits and hospitalizations, as well as chronic anemia requiring frequent iron infusions and/or blood transfusions. Many patients with HHT also develop arteriovenous malformations (AVMs) in vital organs such as the lungs, brain, and liver that, if left untreated, are at risk of rupturing and can result in serious and potentially life-threatening complications including lung or brain hemorrhage, stroke, heart failure, or death. Despite being a rare disease and the second most common inherited bleeding disorder, there are currently no approved therapies. About TX2100, a VHH-Fc fusion antagonist antibodyTX2100, is a VHH-Fc fusion antagonist antibody that binds to the APJ receptor (also known as the apelin receptor; APLNR), a GPCR that mediates signaling by the pro-angiogenic peptide hormone apelin. APJ represents a differentiated approach for the potential treatment of HHT. APJ is a selective anti-angiogenic target that is primarily expressed in endothelial cells and is generally quiescent under normal physiological conditions, but is upregulated during pathologic angiogenesis, including in HHT preclinical models. TX2100 is designed as a selective APJ antagonist intended to inhibit disease-associated angiogenic signaling with the goal of providing a more favorable safety profile compared to less selective anti-angiogenic approaches. Anti-angiogenic agents have demonstrated activity in HHT preclinical models and in patients, and APJ antagonism has shown activity in multiple HHT preclinical models, supporting development of TX2100 for this indication. About TectonicTectonic Therapeutic is a clinical-stage biotechnology company focused on the discovery and development of therapeutic proteins and antibodies that modulate the activity of GPCRs. Leveraging its proprietary technology platform called GEODe™ (GPCRs Engineered for Optimal Discovery), Tectonic is focused on developing biologic medicines that overcome the existing challenges of GPCR-targeted drug discovery and harness the human body to modify the course of disease. Tectonic focuses on areas of significant unmet medical need, often where therapeutic options are poor or nonexistent, as these are areas where new medicines have the potential to improve patient quality of life. Tectonic is headquartered in Watertown, Massachusetts. For more information, please visit https://tectonictx.com/ and follow @TectonicTx on X (formerly Twitter) and LinkedIn. Forward-Looking StatementsThis press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. All statements in this press release other than statements of historical facts are “forward-looking statements.” These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will” and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding: the design, objectives, initiation, timing, progress and results of current and future preclinical studies and clinical trials of Tectonic’s product candidates, including the ongoing Phase 2 clinical trials for its lead product candidate, TX45, in Group 2 PH-HFpEF and in Group 3 PH-ILD and the ongoing Phase 1 clinical trial for TX2100; and the Company’s expected cash runway. These forward-looking statements are based on Tectonic’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties that could cause Tectonic’s clinical development programs, future results or performance to differ materially from those expressed or implied by the forward-looking statements. Many factors may cause differences between current expectations and actual results, including: the potential that success in preclinical testing and earlier clinical trials does not ensure that later clinical trials will generate the same results or otherwise provide adequate data to demonstrate the efficacy and safety of a product candidate; the impacts of macroeconomic conditions, including the conflict in Ukraine and the conflict in the Middle East, heightened inflation and uncertain credit and financial markets, on Tectonic’s business, clinical trials and financial position; unexpected safety or efficacy data observed during preclinical studies or clinical trials; clinical trial site activation or enrollment rates that are lower than expected; Tectonic’s ability to realize the benefits of its collaborations and license agreements; changes in expected or existing competition; changes in the regulatory environment; the uncertainties and timing of the regulatory approval process; and unexpected litigation or other disputes. Other factors that may cause Tectonic’s actual results to differ from those expressed or implied in the forward-looking statements in this press release are identified under the heading “Risk Factors” in Tectonic’s quarterly report on Form 10-Q filed for the quarter ended June 30, 2026 and in other filings that Tectonic makes and will make with the SEC in the future. Tectonic expressly disclaims any obligation to update any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law. Contacts: Investors:Dan FerryLifeSci Advisorsdaniel@lifesciadvisors.com(617) 430-7576 Media:Kathryn MorrisThe Yates Networkkathryn@theyatesnetwork.com(914) 204-6412 Tectonic Therapeutic, Inc.Condensed Consolidated Statements of Operations and Comprehensive Loss(in thousands, except per share data)(unaudited)   Three Months Ended June 30, Six Months Ended June 30,   2026   2025   2026   2025 Operating expenses:        Research and development $18,048  $17,185  $38,919  $30,221 General and administrative  6,170   5,147   12,600   10,409 Total operating expenses  24,218   22,332   51,519   40,630 Loss from operations  (24,218)  (22,332)  (51,519)  (40,630)Other income (expense), net:        Interest income  2,021   3,389   4,202   5,833 Interest expense  (6)  (17)  (14)  (37)Other expense  (5)  (48)  (118)  (80)Total other income, net  2,010   3,324   4,070   5,716 Loss before income tax  (22,208)  (19,008)  (47,449)  (34,914)Income tax expense  (77)  (976)  (77)  (976)Net loss  (22,285)  (19,984)  (47,526)  (35,890)Other comprehensive (loss) income:        Foreign currency translation adjustment  —   (51)  37   (58)Comprehensive loss $(22,285) $(20,035) $(47,489) $(35,948)Net loss per share, basic and diluted $(1.18) $(1.07) $(2.52) $(2.00)Weighted-average common shares outstanding, basic and diluted  18,964,008   18,680,042   18,867,044   17,923,056  Tectonic Therapeutic, Inc.Select Condensed Consolidated Balance Sheet Data(in thousands)(unaudited)    June 30, 2026 December 31, 2025      Cash and cash equivalents  $227,068 $253,798Working capital*   220,729  247,693Total assets   237,034  261,038Total stockholders’ equity   223,846  251,329            *Working capital is defined as current assets less current liabilities  

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Kardium Receives Health Canada Approval for the Globe® Pulsed Field System

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VANCOUVER, British Columbia–(BUSINESS WIRE)–Kardium Inc., a private medical device company that’s advancing the way the world treats atrial fibrillation (AF), announced today that Health Canada has granted a Medical Device Licence for the Globe® Pulsed Field System. Building on the successful U.S. launch of the Globe System following FDA approval in 2025, Health Canada approval marks the next major milestone in expanding access to Kardium’s integrated mapping and pulsed field ablation platfor

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Galaxy Therapeutics Achieves CE Mark for SEAL™ Embolization System, Enabling Commercial Launch Across Europe and International Markets

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MILPITAS, Calif., Aug. 4, 2026 /PRNewswire/ — Galaxy Therapeutics, a privately held medical device company dedicated to advancing the treatment of intracranial aneurysms, today announced that it has received CE Mark under the European Medical Device Regulation (EU MDR 2017/745) for the SEAL™ Embolization System, following successful assessment by Notified […]

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Teleflex Medical OEM Launches as INGENYX to Empower Tomorrow’s MedTech Innovators

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Combining leading in-house expertise with platform-enhancing investments to accelerate advances in engineering, innovation and manufacturing capabilities serving global medical device innovators Marks completion of acquisition by Montagu and Kohlberg PLYMOUTH, Minn., Aug. 04, 2026 (GLOBE NEWSWIRE) — INGENYX, formerly Teleflex Medical OEM, today announced its launch as an independent company following the completion of its acquisition by Montagu and Kohlberg and carve-out from Teleflex Incorporated (NYSE: TFX). The transaction was first announced on December 9, 2025. Rooted in more than 40 years of experience serving medical device manufacturers, INGENYX develops and manufactures custom-engineered interventional catheters and subassemblies, sutures, tubing, wiring, complex extrusion solutions, surgical fibers, and other advanced medical device technologies for customers worldwide. As an independent company, INGENYX is well-positioned to expand its engineering capabilities, accelerate innovation, and strengthen customer collaboration while continuing to deliver the expertise, quality, and reliability medical device manufacturers have come to expect. Greg Stotts, formerly the Chief Executive Officer of Teleflex Medical OEM, continues in that role at INGENYX, and Matt Jennings, Senior Operating Partner at Kohlberg, will serve as Executive Chairman of the Board. “Medical device companies face growing pressure to innovate faster while managing complexity, risk, and cost,” Jennings said. “INGENYX is uniquely positioned to meet that need by serving as a collaborative extension of our customers’ teams, combining design for manufacturability (DFM) methodology, and our proprietary intelligence databank with a deep understanding of the decisions that shape successful products.” Under the INGENYX brand, the company will expand its focus beyond traditional contract manufacturing development to help customers navigate increasingly complex product development, material selection, scalability, and lifecycle challenges. “INGENYX reflects both who we are and where we’re headed,” Stotts added. “For decades, we’ve helped medical device companies bring innovative products to market. As an independent company, we have an opportunity to invest further in the capabilities, expertise, and technologies that help our customers make smarter decisions and accelerate their path to commercialization and beyond.” Key highlights of INGENYX include: Continuity that customers can count on. The same trusted teams, expertise, and customer commitment that have defined the business for decades remain in place under the INGENYX brand.The agility of an independent company. As a standalone organization backed by Kohlberg and Montagu, INGENYX is positioned to move faster and accelerate investments in innovation, engineering, and manufacturing capabilities.A stronger platform for what’s next. With integrated real-world manufacturing expertise and DFM intelligence, INGENYX helps customers make more informed development decisions, reduce risk, accelerate commercialization, and prepare for future product generations. For more information, visit www.ingenyx.com. About INGENYXINGENYX is a leading development and manufacturing partner to global medical device innovators. For more than 40 years, the company has developed and supplied custom-engineered interventional catheter components and subassemblies, surgical fibers, sutures, and other advanced medical device technologies used across high-growth treatment areas, including structural heart, neurovascular, electrophysiology, and urology. Leveraging deep materials science expertise, complex extrusion capabilities, proprietary intelligence, and a vertically integrated operating model, INGENYX helps customers navigate critical decisions from concept through commercial readiness and future product generations. With seven state-of-the-art facilities across the United States, Ireland, and Mexico, INGENYX supports many of the world’s leading medical device companies, helping to bring life-changing technologies to market. About MontaguMontagu is a leading mid-market private equity firm, committed to finding and growing businesses that make the world work. Focusing on businesses with a must-have product or service in a structurally growing marketplace, Montagu brings proven growth capabilities to help companies achieve their ambitions and unlock their full potential. Montagu specializes in carve-out and other first-time buyout investments and has deep expertise in five priority sectors: Healthcare, Financial Sector Services, Critical Data, Digital Infrastructure, and Education. Environmental, Social, and Governance (ESG) forms an integral part of its strategy, and its commitment to responsible investment is fully integrated into its investment and value-creation process. Montagu has €15 billion in assets under management. For more information, visit www.montagu.com. About Kohlberg Founded in 1987, Kohlberg is a leading U.S. middle market investment firm based in Mount Kisco, New York with deep experience investing across private equity and credit. Informed by its thesis-driven White Paper Program, Kohlberg invests in healthcare and services companies characterized by strong brands, recurring revenue streams and leading market positions. Kohlberg manages approximately $17 billion on behalf of investors globally. For more information, please visit www.kohlberg.com. Media Contact:For INGENYXPatty Caballeropatty@pscconsulting.net973-348-5055 For MontaguJames Madsen, Bella LahdoGreenbrook+44 20 7952 2000montagu@greenbrookadvisory.com For KohlbergAmanda Shpiner/Jonathan WarrenGasthalter & Co.212-257-4170media@kohlberg.com

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Galaxy Therapeutics Achieves CE Mark for SEAL™ Embolization System, Enabling Commercial Launch Across Europe and International Markets

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MILPITAS, Calif., Aug. 4, 2026 /PRNewswire/ — Galaxy Therapeutics, a privately held medical device company dedicated to advancing the treatment of intracranial aneurysms, today announced that it has received CE Mark under the European Medical Device Regulation (EU MDR 2017/745) for the…

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U.S. News and World Report Ranks MedStar Health Hospitals #1 in the D.C. Region for Cancer, Cardiology, Heart & Vascular Surgery, and Rehabilitation

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COLUMBIA, Md., Aug. 4, 2026 /PRNewswire/ — MedStar Health is celebrating high praise for its hospitals in U.S. News & World Report’s Best Hospitals rankings for 2026-27, including prestigious national and regional recognition for exceptional patient care. Each year, U.S. News ranks…

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Implicity’s Next-Generation ILR ECG Analyzer Earns FDA Clearance

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Cloud-based AI algorithm supports implantable cardiac monitors from all major manufacturers, reducing false-positive alerts by up to 76% while maintaining high sensitivity for true events Cambridge, Mass., July 28, 2026 – Implicity, a leader in remote patient monitoring and cardiac data management solutions, today announced that the U.S. Food and […]

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