A Breakthrough in Dialysis Access ST. LOUIS, Jan. 13, 2026 /PRNewswire/ — Amplifi Vascular, Inc., has been granted Breakthrough Device Designation and Category B assignment from the Centers for Medicare & Medicaid Services (CMS) for the Amplifi Vein Dilation System. This significant…
Peripheral/Endo
Major Medical Devices Secures Strategic Funding to Advance Novel AAA Repair Device to Market
NEW YORK, Jan. 9, 2026 /PRNewswire/ — Major Medical Devices, Inc. (http://www.majormedicaldevices.com) (MMD), an emerging innovator in vascular intervention technologies with a highly differentiated, potentially quick to market device in a $3 billion market, announces strategic funding…
GORE GAINS FDA APPROVAL FOR FIRST DEEP VENOUS STENT INDICATED FOR THE IVC AND ILIOFEMORAL VEINS
The GORE® VIABAHN® FORTEGRA Venous Stent is engineered to offer an optimal balance of conformability and compression resistance for treating a broad range of patients. FLAGSTAFF, Ariz., Jan. 6, 2026 /PRNewswire/ — W. L. Gore & Associates’ medical business (Gore) has announced the FDA…
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 […]
Johnson & Johnson Receives FDA Approval for TRUFILL n‑BCA Liquid Embolic System for the Treatment of Symptomatic Chronic Subdural Hematoma
– TRUFILL n-BCA is now indicated for embolization of the middle meningeal artery (MMA) for the treatment of symptomatic subacute and Chronic Subdural Hematoma (cSDH) as an adjunct to surgery. – Approval builds on a trusted solution in neurovascular embolization for over 25 years. IRVINE,…
Profusa U.S. Study Met Primary End Points as Presented at Late Breaking Clinical Trials at Paris Vascular Insights 2025
Data from FDA-advised study demonstrates Lumee™ Oxygen tissue monitoring is a safe and effective long-term method in PAD patients and will support potential FDA submission; strongly correlates with transcutaneous partial pressure of oxygen
MMI Wins FDA Clearance and Completes First U.S. Clinical Use of Robotic Microsurgical Dissection Instruments with Symani
First U.S. Patient Treated with NanoWrist Dissection Instruments, Marking Early Clinical Adoption and Portfolio Growth JACKSONVILLE, FL —December 9, 2025 — MMI (Medical Microinstruments, Inc.), a robotics company dedicated to expanding treatment options and improving outcomes for patients with complex conditions, today announced that it received U.S. Food and […]
Brainomix Announces New Study Published in Lancet Digital Health Demonstrating Impact of Brainomix 360 Stroke to Increase Endovascular Thrombectomy Rates
Study in Lancet Digital Health represents the largest real-world evaluation of stroke AI imaging, encompassing data from more than 450,000 patients admitted to 107 NHS England hospitals over a 5-year period Brainomix 360 Stroke was deployed to 26 hospitals to evaluate the impact on stroke…
Carta Healthcare Partners with Fivos to Elevate Data Quality and Advance Vascular Patient Care
SAN FRANCISCO, Dec. 2, 2025 /PRNewswire/ — Carta Healthcare, a leading provider of AI-powered clinical data abstraction solutions, today announced a strategic partnership with Fivos, a leading provider of data solutions for medical research organizations and device manufacturers, as well…
MMI Announces CPT Code and CMS Reimbursement for Robotic Lymphatic Surgery, Unlocking Market Access and Growth Potential
MMI, today announced that the American Medical Association (AMA) has issued a new Current Procedural Terminology (CPT®) code for lymphovenous bypass.



