Other News

GE HealthCare announces U.S. FDA 510(k) clearance for View, a next‑generation diagnostic viewer enabling anywhere‑access to radiologists

CHICAGO–(BUSINESS WIRE)–GE HealthCare today announced that View, the powerful viewer within the Genesis™ Radiology Workspace, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). Designed as a fast, diagnostic, zero‑footprint viewer, View serves as the core anchor of the Genesis Radiology Workspace.2 This next‑generation solution aims to transform radiology workflows, unify the user experience, and empower radiologists with greater efficiency and precision. Studies

SS Innovations Announces Completion of an $18.6 Million Private Placement to Support Growth Initiatives

Financing led by Certain of the Company’s Directors and Executive OfficersFORT LAUDERDALE, Fla., March 09, 2026 (GLOBE NEWSWIRE) — SS Innovations International, Inc. (the “Company” or “SS Innovations”) (Nasdaq: SSII), a developer of innovative surgical robotic technologies dedicated to making robotic surgery affordable and accessible to a global population, today announced that on March 6, 2026, the Company completed a private placement of its common stock (the “Private Placement”) which generated approximately $18.6 million in gross proceeds, before deducting offering expenses. In the offering, the Company offered and sold a total of 5,774,839 shares of common stock consisting of: an aggregate of 1,300,006 shares of common stock at an average price of $4.00 per share, or a total of approximately $5.2 million, to Dr. Sudhir Srivastava, our Chairman and Chief Executive Officer ($2.0 million), Dr. Frederic H. Moll, our Vice-Chairman ($2.0 million), and Tim Adams, a director ($1.197 million); andan aggregate of 4,474,833 shares of common stock at $3.00 per share, or a total of approximately $13.4 million, to existing and new investors, led by Manipal Global Health Services, an existing shareholder.   SS Innovations intends to use the net proceeds from this financing for working capital and other general corporate purposes, including advancing the Company’s global expansion efforts. In connection with a $2.5 million investment by one of the non-affiliate investors in the Private Placement, SS Innovations will pay a FINRA member firm a cash commission of $175,000 (7% of the investment) and issue to such firm five-year warrants to purchase 41,667 shares of our common stock at an exercise price of $3.45 per share. Dr. Sudhir Srivastava, Chairman of the Board and Chief Executive Officer of SS Innovations, commented, “The net proceeds from this financing will advance our growth initiatives in India and other existing global markets, while supporting our preparation for entry into the United States and European Union markets. We anticipate that the U.S. Food and Drug Administration will complete its review of our 510(k) premarket notification for our SSi Mantra surgical robotic system by mid-2026. We also continue along the pathway towards a European Union CE marking certification for the SSi Mantra, which we believe we can also obtain in 2026.” Dr. Srivastava continued, “Insider participation in this financing reflects our strong confidence in SS Innovations’ future and our commitment to democratizing access to world-class surgical robotic care. We appreciate the continuing support of Manipal Global Health Services, a large existing shareholder, and welcome a respected group of new shareholders in the Company.” The securities being sold in the Private Placement have not been registered under the Securities Act of 1933, as amended (the “Securities Act”), or applicable state securities laws and accordingly may not be offered or sold in the United States absent registration with the Securities and Exchange Commission or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. About SS Innovations SS Innovations International, Inc. (Nasdaq: SSII) develops innovative surgical robotic technologies with a vision to make the benefits of robotic surgery affordable and accessible to a larger segment of the global population. The Company’s product range includes its proprietary “SSi Mantra” surgical robotic system and its comprehensive suite of “SSi Mudra” surgical instruments, which support a variety of robotic surgical procedures including cardiac surgery. An American company headquartered in India, SS Innovations plans to expand the global presence of its technologically advanced, user-friendly, and cost-effective surgical robotic solutions. Visit the Company’s website at ssinnovations.com or LinkedIn for more information and updates. About the SSi Mantra The SSi Mantra surgical robotic system is a user-friendly, modular, multi-arm system with many advanced technology features, including: 3 to 5 modular robotic arms, an open-faced ergonomic surgeon command center, a large 3D 4K monitor, a touch panel monitor for all patient related information display, a virtual real-time image of the robotic patient side arm carts, and the ability for superimposition of 3D models of diagnostic imaging. A vision cart provides the table-side team with the same magnified 3D 4K view as the surgeon to provide better safety and efficiency. The SSi Mantra utilizes over 40 different types of robotic endo-surgical instruments to support different specialties, including cardiac surgery. The SSi Mantra has been clinically validated in India in more than 100 different types of surgical procedures. Forward Looking StatementsThis press release may contain statements that are not historical facts and are considered forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. The words “anticipate,” “assume,” “believe,” “estimate,” “expect,” “will,” “intend,” “may,” “plan,” “project,” “should,” “could,” “seek,” “designed,” “potential,” “forecast,” “target,” “objective,” “goal,” or the negatives of such terms or other similar expressions to identify such forward-looking statements. These statements relate to future events or SS Innovations’ future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Except as required by applicable law, including the securities laws of the United States and the rules and regulations of the SEC, we do not assume any obligation to update any forward-looking statement. Investor Contact:The Equity Group        Kalle Ahl, CFA                T: (303) 953-9878        kahl@theequitygroup.com Devin Sullivan, Managing Director T: (212) 836-9608dsullivan@theequitygroup.com Media Contact:RooneyPartners LLCKate BarretteT: (212) 223-0561kbarrette@rooneypartners.com

Late-Breaking Clinical Trial Presentation of the First-Ever US Cohort of Over 4,000 CathWorks FFRangio Patients Demonstrates Similar Clinical Outcomes to Invasive Pressure Wire-Guided PCI through 2 Years

WASHINGTON, March 7, 2026 /PRNewswire/ — Today at the Cardiovascular Research Technologies (CRT) annual conference taking place in Washington, DC, Dr. Christopher Chieh Yang Koo from National University Hospital Singapore, on behalf of investigators from Smith Center for Outcomes…

Solid Biosciences Announces Oversubscribed $240 Million Private Placement

CHARLESTOWN, Mass., March 06, 2026 (GLOBE NEWSWIRE) — Solid Biosciences Inc. (Nasdaq: SLDB), a life sciences company developing precision genetic medicines for neuromuscular and cardiac diseases, today announced that it has entered into a securities purchase agreement with a select group of institutional accredited investors for an approximately $240 million private placement, before deducting placement agent fees and offering expenses, which is expected to close on or about March 9, 2026, subject to the satisfaction of customary closing conditions. The private placement is being conducted in accordance with applicable Nasdaq rules and was priced to satisfy the “Minimum Price” requirement (as defined in the Nasdaq rules). In the private placement, the Company is selling 14,973,257 shares of common stock at a price of $5.61 per share and, in lieu of common stock to investors who so choose, pre-funded warrants to purchase up to 27,807,482 shares of common stock at a price of $5.609 per pre-funded warrant. Each pre-funded warrant will have an exercise price of $0.001 per share, will be exercisable immediately, and will be exercisable until exercised in full. The private placement was anchored by existing and new investors, including Perceptive Advisors, Bain Capital Life Sciences, RA Capital Management, Invus, Vestal Point Capital, Janus Henderson Investors, and Deep Track Capital, among others. The Company expects to use net proceeds from the private placement to fund ongoing pipeline development programs, business development activities, and for working capital and other general corporate purposes. Leerink Partners and Citigroup are acting as joint lead placement agents for the financing. Cantor is acting as co-lead placement agent for the financing. Truist and H.C. Wainwright & Co. are acting as co-placement agents for the financing. The securities to be sold in the private placement have not been registered under the Securities Act of 1933, as amended (the “Securities Act”), or any state or other applicable jurisdiction’s securities laws, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdictions’ securities laws. The Company has agreed to file a registration statement with the U.S. Securities and Exchange Commission (the “SEC”) registering the resale of the shares of common stock issued in the private placement and the shares of common stock issuable upon the exercise of the pre-funded warrants issued in the private placement no later than the 30th day after the closing of the private placement. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any offer, solicitation or sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful. Any offering of the securities under the resale registration statement will only be made by means of a prospectus. About Solid Biosciences Solid Biosciences is a precision genetic medicine company focused on advancing a portfolio of gene therapy candidates targeting rare neuromuscular and cardiac diseases, including SGT-003 for Duchenne muscular dystrophy (Duchenne), SGT-212 for Friedreich’s ataxia (FA), SGT-501 for catecholaminergic polymorphic ventricular tachycardia (CPVT), SGT-601 for TNNT2-mediated dilated cardiomyopathy and additional fatal, genetic cardiac diseases. The Company is also focused on developing innovative libraries of genetic regulators and other enabling technologies with promising potential to significantly impact gene therapy delivery cross-industry. Solid is advancing its diverse pipeline and delivery platform in the pursuit of uniting experts in science, technology, disease management, and care. Patient-focused and founded by those directly impacted by Duchenne, Solid’s mission is to improve the daily lives of patients living with devastating rare diseases. Cautionary Note Regarding Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the anticipated closing of the private placement; the anticipated use of proceeds from the private placement; the filing of a registration statement to register the resale of the shares and pre-funded warrant shares to be issued and sold in the private placement; future expectations, plans and prospects for the Company; and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” “working” and similar expressions. Any forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in, or implied by, such forward-looking statements. These risks and uncertainties include, but are not limited to: market and other financial conditions and the impact of general economic, industry or political conditions in the United States or internationally; whether the conditions for the closing of the private placement will be satisfied; the Company’s ability to advance SGT-003 and other clinical and preclinical programs, capsid libraries and other enabling technologies on the timelines expected or at all; obtain and maintain necessary approvals from the FDA and other regulatory authorities; replicate in clinical trials positive results found in preclinical studies of the Company’s product candidates; obtain, maintain or protect intellectual property rights related to its product candidates; enroll patients in ongoing trials; activate clinical trial sites; replicate preliminary or interim data from clinicals trials in the final data of such trials; compete successfully with other companies that are seeking to develop Duchenne, FA, CPVT and other neuromuscular and cardiac treatments and gene therapies; manage expenses; and raise the substantial additional capital needed, on the timeline necessary, to continue development of SGT-003 and its other candidates, achieve its other business objectives and continue as a going concern. For a discussion of other risks and uncertainties, and other important factors, any of which could cause the Company’s actual results to differ from those contained in the forward-looking statements, see the “Risk Factors” section, as well as discussions of potential risks, uncertainties and other important factors, in the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2025 and other filings that the Company may make with the SEC in the future. In addition, the forward-looking statements included in this press release represent the Company’s views as of the date hereof and should not be relied upon as representing the Company’s views as of any date subsequent to the date hereof. The Company anticipates that subsequent events and developments will cause the Company’s views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so. Solid Biosciences Investor Contact:Nicole AndersonSenior Director, Investor Relations and Corporate CommunicationsSolid Biosciences Inc.investors@solidbio.com Media Contact:Glenn SilverFINN Partnersglenn.silver@finnpartners.com

VDyne Appoints Mike Buck as Chairman and CEO to Lead Next Phase of its TTVR Program

MAPLE GROVE, Minn.–(BUSINESS WIRE)–VDyne Inc. (“VDyne”), a privately held medical device company developing a transcatheter tricuspid valve replacement (TTVR) system to treat tricuspid regurgitation, today announced the appointment of Mike Buck as Chairman and Chief Executive Officer. Mr. Buck brings more than 30 years of leadership experience in cardiovascular medical […]

Harrison.ai Receives FDA Clearance for Acute Infarct Triage on Non-contrast CT Brain

Approval marks Harrison.ai’s second out of three Breakthrough designations to reach marketing authorization, and 9th FDA clearance covering a total of 13 radiological findings. SYDNEY & BOSTON–(BUSINESS WIRE)–Harrison.ai today announced FDA 510(k) clearance for acute infarct triage on non-contrast CT Brain. Acute infarct is one of the most difficult findings to […]

Profound Medical Reports Fourth Quarter and Full Year 2025 Financial Results

TORONTO, March 05, 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 reported financial results for the fourth quarter and full year ended December 31, 2025. 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).   Business Highlights Q4-2025 revenue grew 43% year-over-year and 13% sequentially quarter-over-quarter to a record $6.0 million. Profound’s TULSA-PRO® qualified sales pipeline also continues to grow, and currently stands at 110 new systems being classified within one of the “Verify, Negotiate and Contracting” stages.The Company’s TULSA-PRO installed base stood at 78 as of December 31, 2025 and, due to its strong capital sales pipeline, Profound currently expects to reach approximately 120 installs by the end of 2026.Profound continued to see a wide variety of prostate disease patients treated by its TULSA-PRO customers in the fourth quarter of 2025: 67% were treated for prostate cancer only, 17% were hybrid patients suffering from both prostate cancer and benign prostatic hyperplasia (“BPH”), 13% were salvage, and 3% were men with BPH only;For cancer grade, 5% were GG1, 57% were GG2, 29% were GG3, and 9% were GG4 & GG5;By intention-to-treat, 44% were whole gland; 24% were sub-total but more than half the gland; 24% were hemi-ablations, and 9% were focal therapy; andFor prostate size, 9% were

GAIA and Daiichi Sankyo Europe Enter Exclusive Partnership to Launch Next-Generation Digital Therapeutic for Cardiovascular Care in Europe.

HAMBURG, Germany & MUNICH–(BUSINESS WIRE)–GAIA, the pioneer in evidence-based digital therapeutics and Daiichi Sankyo Europe, today announced an exclusive strategic partnership to commercialize lipodia upon regulatory approval1. This digital therapeutic is designed to support adults living with hypercholesterolemia. The comprehensive collaboration brings together GAIA’s long-standing expertise in developing clinically validated […]