Author: Ken Dropiewski

Shape Memory Medical Secures EU MDR Certification for IMPEDE® Embolization Plug Product Family, Accelerating Global Innovation in Vascular Care

SAN JOSE, Calif.–(BUSINESS WIRE)–Shape Memory Medical Inc., innovator of the proprietary shape memory polymer technology for endovascular applications, announced that its IMPEDE® Embolization Plug product family has received certification as a Class III device under the European Union (EU) Medical Device Regulation (MDR) 2017/745. The IMPEDE Embolization Plug family, previously […]

CVRx to Present at the 44th Annual J.P. Morgan Healthcare Conference

MINNEAPOLIS, Dec. 22, 2025 (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 that the management team will present at the 44th Annual J.P. Morgan Healthcare Conference in San Francisco on Wednesday, Jan. 14, 2026. The Company’s presentation will begin at 3:45 p.m. (PT). A live webcast of the event can be found at ir.cvrx.com. An archived version of the presentation will be available following the live event and can be accessed at the same location for a limited time.About CVRx, Inc.CVRx is a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. Investor Contact:Mark Klausner or Mike VallieICR Healthcare443-213-0501ir@cvrx.com  Media Contact:Emily MeyersCVRx, Inc.763-416-2853emeyers@cvrx.com 

ZOLL Launches Fifth-Generation LifeVest® WCD

CHELMSFORD, Mass.–(BUSINESS WIRE)–ZOLL®, an Asahi Kasei company that manufactures medical devices and related software solutions, announced the U.S. launch of the next generation LifeVest® wearable cardioverter defibrillator (WCD). This marks the fifth FDA-approved LifeVest WCD, which works seamlessly with the recently launched next generation LifeVest WCD garment, the most comfortable LifeVest […]

Heartflow Plaque Analysis Now Supported by Scientific Statements From American College of Cardiology and American Heart Association for Personalized Management of Patients with Suspected CAD

Reinforces Role of AI-Powered Quantitative Coronary Plaque AssessmentMOUNTAIN VIEW, Calif., Dec. 18, 2025 (GLOBE NEWSWIRE) — Heartflow, Inc. (Heartflow) (Nasdaq: HTFL), the leader in AI technology for coronary artery disease (CAD), announced the American College of Cardiology (ACC) and the American Heart Association (AHA) published new scientific statements supporting the prognostic value of quantifying coronary plaque and reinforcing the critical role of the coronary computed tomography angiography (CTA) + Heartflow pathway in CAD patient management. The ACC’s consensus recommendations, published this week in JACC: Cardiovascular Imaging, highlight the importance of quantitative plaque assessment and underscore the benefits of adopting AI-powered Heartflow Plaque Analysis for personalized, precision cardiac care.1 The ACC statement elevates plaque analysis from an emerging technology to a defined clinical consideration in CAD management, outlining appropriate patient selection and best practices for interpreting and reporting. In direct alignment with the ACC’s call for rigorous quality assurance, reproducible results, and “human in the loop” analysis, Heartflow delivers a differentiated standard for clinical plaque quantification by combining AI-driven analysis with expert quality review. Heartflow Plaque Analysis is the only FDA-cleared, AI-powered plaque quantification tool with 95% agreement to the gold standard, IVUS, using blinded core lab adjudication.2 This rigor, together with Heartflow’s commitment to standardized reporting and advanced algorithmic approaches such as adaptive thresholds, reflects a level of validation and quality oversight consistent with ACC guidance. The AHA statement, published recently in Circulation, reinforces plaque burden and composition as central in managing nonobstructive CAD.3 The expert authors emphasize that patients with nonobstructive CAD should not be considered low-risk, recognizing that coronary plaque burden, extent, and composition are major determinants of outcomes. Earlier this year, a commission perspective published in The Lancet called for a fundamental shift in managing CAD, urging clinicians to focus on identifying and managing plaque early, before the opportunity for prevention has been lost.4 Together, the scientific statements from ACC and AHA reinforce that broader paradigm shift toward understanding plaque burden, not just artery obstruction, in modern CAD management. “The ACC and AHA scientific statements address an important need by providing evidence-based consensus recommendations for clinicians and imagers, solidifying coronary CTA-based quantitative plaque analysis as a powerful tool for enhanced risk stratification in patients with suspected CAD,” said Ron Blankstein, M.D., writing committee member for both the ACC and AHA statements, Director of Cardiac Computed Tomography at Brigham and Women’s Hospital, and Professor of Medicine and Radiology at Harvard Medical School. “These statements highlight the limitations of current methods to assess risk based on risk factors or stenosis severity alone. Integrating AI-powered technology into clinical practice using ACC and AHA’s guidance can help clinicians move beyond diagnosing blockages, toward predicting and preventing major cardiovascular events.” Both the ACC and AHA scientific statements support the use of quantitative coronary plaque analysis to identify high-risk patients, enabling the immediate and appropriate initiation of preventive treatment. Heartflow Plaque Analysis addresses the need to quantify disease following visual detection of plaque, and is delivered instantly upon order to maintain seamless clinical integration and enable timely clinical decision-making. “The ACC and AHA scientific statements signal growing consensus that plaque assessment is essential for risk stratification, prevention, and long-term CAD management. Heartflow Plaque Analysis enables more precise risk stratification for personalized, preventive treatment plans,” said Campbell Rogers, M.D., F.A.C.C., Chief Medical Officer at Heartflow. “The expert guidance articulates the need for rigorous validation and standardization, which Heartflow is uniquely positioned to address, given our technology and quality systems already align with these stringent recommendations. We are energized by the opportunity to continue collaborating with clinicians as a catalyst to redefine and improve precision cardiovascular care.” The ACC and AHA’s scientific statements reflect a growing body of clinical evidence further substantiating the prognostic significance of Heartflow Plaque Analysis. A retrospective analysis of symptomatic patients from a cohort of the FISH&CHIPS Study presented at the AHA Scientific Sessions 2025 provided the largest validation to date of the Heartflow Plaque Staging framework based on total plaque volume measurement as a predictor of future heart attacks or cardiovascular death.5 The company is generating additional real-world evidence through the DECIDE registry, the largest prospective registry evaluating the clinical impact of Heartflow Plaque Analysis on medical management decisions. The DECIDE registry showed that more than 50% of patients had their medical management changed when Plaque Analysis with Plaque Staging* was added compared to their management based on CCTA alone.6 About Heartflow’s Technology and ResearchHeartflow’s technology is redefining precision cardiovascular care through clinically-proven AI and the world’s largest coronary imaging dataset. Heartflow has been adopted by more than 1,400 institutions globally and continues to strengthen its commercial presence to make this cutting-edge solution more widely available to an increasingly diverse patient population. Backed by ACC/AHA guidelines and supported by more than 600 peer-reviewed publications, Heartflow has redefined how clinicians manage care for over 500,000 patients worldwide. Key benefits include: Proprietary data pipeline: Built from more than 110 million annotated CTA images, Heartflow’s data foundation powers advanced AI models that deliver highly accurate, reproducible insights across diverse patient populations.Extensive clinical and real-world validation: Heartflow’s AI-driven solutions have been validated through clinical evidence in over 100 studies assessing over 365,000 patients. Proven in real-world practice with reproducibility and accuracy, Heartflow’s coronary CTA image acceptance rates exceed 97%.Seamless clinical integration via upgraded workflow: Heartflow delivers final quality-reviewed analyses instantly upon order, enabling clinicians to move from diagnosis to decision without delay.Quality system, global security and patient-data integrity compliance: Heartflow meets or exceeds leading international standards, including HITRUST, SOC 2 Type 2, ISO 13485, and ISO 27001. About Heartflow, Inc.Heartflow is transforming coronary artery disease from the world’s leading cause of death into a condition that can be detected early, diagnosed accurately, and managed for life. The Heartflow One platform uses AI to turn coronary CTA images into personalized 3D models of the heart, providing clinically meaningful, actionable insights into plaque location, volume, and composition and its effect on blood flow — all without invasive procedures. Discover how we’re shaping the future of cardiovascular care at heartflow.com. Media ContactElliot Levyelevy@heartflow.com Investor ContactNick Laudiconlaudico@heartflow.com 1 Chandrashekhar Y, Blankstein R, Shaw L. et al. Quantitative Coronary Plaque Analysis in Clinical Practice: 2025 ACC Scientific Statement: A Report of the American College of Cardiology. J Am Coll Cardiol Img. doi: 10.1016/j.jcmg.2025.11.0082 Ihdayhid A, et al. Radiol Cardiothorac Imaging. 2024. doi: 10.1148/ryct.230312 and internal bridging study with ICC correlation between first generation and second generation Plaque Analysis algorithm.3 Slipczuk L, Blankstein R, Bucciarelli-Ducci C. et al. State of the art: evaluation and medical management of nonobstructive coronary artery disease in patients with chest pain: a scientific statement from the American Heart Association. Circulation. 2025;152:e443–e466. doi: 10.1161/CIR.00000000000013944 Zaman, Sarah et al. The Lancet Commission on rethinking coronary artery disease: moving from ischaemia to atheroma. The Lancet. 2025;405,10486:1264-1312. Doi: 10.1016/S0140-6736(25)00055-85 Fairbairn et al. AHA 2025.6 DECIDE Registry. Rinehart, et al., presented at SCCT 2025.*Heartflow Plaque Analysis is an FDA-cleared device. Heartflow Plaque Staging is an investigational-only framework, and its safety and effectiveness have not been reviewed by the FDA.

Pulse Biosciences Announces FDA IDE Approval to Initiate its nPulse Cardiac Catheter Ablation System Study for the Treatment of Atrial Fibrillation

HAYWARD, Calif.–(BUSINESS WIRE)–Pulse Biosciences, Inc. (Nasdaq: PLSE), a company leveraging its novel nPulse™ technology using its proprietary Nanosecond Pulsed Field Ablation™ (nanosecond PFA or nsPFA™) energy, today announced that the U.S. Food and Drug Administration (FDA) has granted approval for the Company’s Investigational Device Exemption (IDE), allowing Pulse Biosciences to […]

Huxley Medical’s SANSA Receives Diagnostic ECG Clearance from FDA, Paving Way for First Solution to Systematically Detect Arrhythmias During Home Sleep Testing

ATLANTA, Dec. 18, 2025 /PRNewswire/ — Huxley Medical, Inc. announced the SANSA® home sleep apnea test has received regulatory clearance from the United States Food and Drug Administration (FDA) to be used as a diagnostic ECG monitor, making SANSA the first home sleep apnea test capable…

Conavi Medical Corp. Announces Pricing of Public Offering of Common Shares and/or Pre-Funded Warrants

NOT FOR DISTRIBUTION TO U.S. NEWS WIRE SERVICES OR FOR DISSEMINATION IN THE UNITED STATES FINAL PROSPECTUS WILL BE ACCESSIBLE ON SEDAR+ TORONTO, Dec. 18, 2025 (GLOBE NEWSWIRE) — Conavi Medical Corp. (TSXV: CNVI) (“Conavi” or the “Company”), a commercial stage medical device company focused on designing, manufacturing, and marketing imaging technologies to guide common minimally invasive cardiovascular procedures, is pleased to announce the pricing and terms of its previously announced public offering. The offering is of common shares of the Company (“Common Shares”) and/or pre-funded common share purchase warrants of the Company (“Pre-Funded Warrants” and, together with the Common Shares, the “Securities”) in lieu of Common Shares (the “Offering”). The Offering is being conducted on a commercially reasonable efforts agency basis for the issuance of a minimum of 33,333,333 Securities and a maximum of 44,444,444 Securities at a price of $0.45 per Common Share or $0.44999 per Pre-Funded Warrant, for gross proceeds of between $15,000,000 and $20,000,000. Each Pre-Funded Warrant issued in lieu of a Common Share at the election of any purchaser entitles the holder thereof to acquire one Common Share at an exercise price of $0.00001 per Common Share. The Pre-Funded Warrants will not expire and may be exercised on a “net” or “cashless” basis. The Company intends to use the net proceeds from the Offering to obtain US FDA 510(k) clearance of the next generation Novasight Hybrid system, as well as complete a limited market release and initiate a broader commercial launch in the United States. The Company also intends to use the net proceeds for working capital and other general corporate purposes. The Offering is expected to be completed pursuant to the terms and conditions of an agency agreement entered into between the Company and Bloom Burton Securities Inc. (the “Agent”). The Company is expecting to file today, on December 18, 2025, a final short form prospectus (the “Final Prospectus”) with the securities regulatory authorities in the provinces of Alberta, British Columbia, and Ontario. There will not be any sale of Securities until a receipt for the Final Prospectus has been issued. The Offering may be completed in one or more tranches and is expected to close initially on or about December 23, 2025, or such other date as may be mutually agreed to by the Company and the Agent (the “Closing Date”). The Offering is subject to the satisfaction of customary closing conditions, including the receipt of all necessary regulatory and stock exchange approvals, including approval of the TSX Venture Exchange (“TSXV”). The Company will pay to the Agent a cash fee equal to 6.5% of the gross proceeds raised under the Offering, and grant the Agent compensation options equal to 6.5% of the aggregate number of Securities issued under the Offering (the “Compensation Options”), provided however the Agent will receive a reduced cash commission of 3.25% and no Compensation Options in respect of Securities sold to certain purchasers on a president’s list to be agreed to between the Company and the Agent. Each Compensation Option shall entitle the holder to buy one Common Share at the same price per Common Share as under the Offering. The Compensation Options shall be exercisable until that date which is 24 months following the Closing Date. In addition, the Securities are anticipated to be offered by way of private placement in certain jurisdictions outside of Canada pursuant to and in compliance with applicable securities laws. This press release is not an offer to sell or the solicitation of an offer to buy the Securities in any jurisdiction in which such offer, solicitation, or sale would be unlawful prior to qualification or registration under the securities laws of such jurisdiction. The Securities being offered have not been, nor will they be, registered under the United States Securities Act of 1933, as amended (the “U.S. Securities Act”), and such Securities may not be offered or sold to, or for the account or benefit of, persons in the United States or U.S. persons except pursuant to an exemption from the registration requirements under the U.S. Securities Act and applicable U.S. state securities laws. “United States” and “U.S. persons” have the meanings ascribed to them in Regulation S under the U.S. Securities Act. Access to the Final Prospectus and any amendments to such documents will be provided in accordance with securities legislation relating to procedures for providing access to a short form prospectus and any amendment thereto. The Final Prospectus (when filed) will be accessible on SEDAR+ at www.sedarplus.ca. Alternatively, an electronic or paper copy of the Final Prospectus (when filed), as well as any amendment to such documents, may be obtained without charge from the Agent by email at ECM@bloomburton.com, by telephone at 416-640-7585 or by providing the contact with an email address or address, as applicable. The Final Prospectus (when filed) contains important, detailed information about the Company and the Offering. Prospective investors should read the Final Prospectus (when filed) before making an investment decision. About Conavi Medical Conavi Medical is focused on designing, manufacturing, and marketing imaging technologies to guide common minimally invasive cardiovascular procedures. Its patented Novasight Hybrid™ System is the first to combine intravascular ultrasound (IVUS) and optical coherence tomography (OCT) into a single device, enabling simultaneous and co-registered imaging of coronary arteries. The first-generation Novasight Hybrid™ System has 510(k) regulatory clearance in the U.S., Canada, China, and Japan. For more information, visit http://www.conavi.com. CONTACT: Christina Cameron IR@conavi.com Notice on forward-looking statements: This press release includes forward-looking information or forward-looking statements within the meaning of applicable securities laws regarding Conavi and its business, which may include, but are not limited to, statements with respect to the anticipated terms and jurisdictions of the Offering; securities offered thereunder; the timing of the Offering, including the anticipated Closing Date and timing for the Final Prospectus; use of proceeds from the Offering; fees anticipated to be paid to the Agent and terms thereof; and regulatory and exchange approvals, including the listing of the Common Shares offered pursuant to the Offering on the TSXV. All statements that are, or information which is, not historical facts, including without limitation, statements regarding future estimates, plans, programs, forecasts, projections, objectives, assumptions, expectations or beliefs of future performance, are “forward-looking information or statements”. Often but not always, forward-looking information or statements can be identified by the use of words such as “shall”, “intends”, “anticipate”, “believe”, “plan”, “expect”, “intend”, “estimate” “anticipate” or any variations (including negative variations) of such words and phrases, or state that certain actions, events or results “may”, “might”, “can”, “could”, “would” or “will” be taken, occur, lead to, result in, or, be achieved. Such statements are based on the current expectations and views of future events of the management of the Company. They are based on assumptions and subject to risks and uncertainties. Although management believes that the assumptions underlying these statements are reasonable, they may prove to be incorrect. The forward-looking events and circumstances discussed in this release, may not occur and could differ materially as a result of known and unknown risk factors and uncertainties affecting the Company, including, without limitation, those listed in the “Risk Factors” section of the Final Prospectus (which, when filed, will be available on the Company’s profile at www.sedarplus.ca). Although Conavi 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. Accordingly, readers should not place undue reliance on any forward-looking statements or information. No forward-looking statement can be guaranteed. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and Conavi does not undertake any obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise. No regulatory authority has approved or disapproved the content of this press release. Neither the TSX Venture Exchange nor its Regulatory Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this press release.