SAN JOSE, Calif.–(BUSINESS WIRE)–Shape Memory Medical Inc., the innovator of the only commercially available volume-expanding shape memory polymer for endovascular embolization applications, announced today that it has received approvals from both Singapore’s Health Science Authority (HSA) and Malaysia’s Medical Device Authority (MDA) to market the IMPEDE Embolization Plug, the IMPEDE-FX […]
Peripheral/Endo
Amplifi Vascular Announces Successful First-in-Human Study Results, Closes $6.8M Series A, and Receives FDA IDE Approval
Company announces positive first-in-human study results, the close of a $6.9 million Series A financing, and FDA approval of its Investigational Device Exemption. ST. LOUIS, Oct. 9, 2025 /PRNewswire/ — Amplifi Vascular, developer of the first-of-its-kind Vein Dilation System designed to…
Prytime Medical Devices Receives World’s First Extended Duration FDA 510(k) Clearance for pREBOA-PRO™ Catheter
BOERNE, Texas, Oct. 8, 2025 /PRNewswire/ — Building once again on their first mover position as a leader in endovascular hemorrhage control and resuscitation, Prytime Medical Devices, Inc. (Prytime) this week announced a new FDA 510(k) clearance for their flagship pREBOA-PRO™ Catheter….
Cagent Vascular Expands Serranator Product Line with Launch of 7.0 mm and 8.0 mm Sizes
New larger diameters broaden treatment options for physicians managing complex peripheral artery disease WAYNE, Pa.–(BUSINESS WIRE)–Cagent Vascular, a leader in innovative endovascular technologies, today announced the commercial launch of the Serranator® PTA Serration Balloon Catheter in 7.0 mm and 8.0 mm diameters. This expansion brings the proven benefits of serration […]
Remedy Robotics Debuts Pioneering Endovascular Surgical Robotic System and Completes World’s First Fully Remote Neurointerventional Procedures
Groundbreaking remotely operable robotic system to transform intervention for stroke and cardiovascular disease, while radically expanding access to care for patients around the world. SAN FRANCISCO, Oct. 6, 2025 /PRNewswire/ — Remedy Robotics, Inc., a leading medical technology company,…
FastWave Medical Names Leading Vascular Specialists as Principal Investigators for Peripheral IVL Trial
Renowned endovascular specialists from Columbia and Stanford to guide pivotal trial of Artero™ electric IVL system. MINNEAPOLIS, Sept. 30, 2025 /PRNewswire/ — FastWave Medical, a pioneering intravascular lithotripsy (IVL) startup, today announced the appointment of its principal…
AngioSafe Unveils Atheroplasty Innovation Following FDA 510(k) Clearance, CE Mark Approval, and First Real-World Procedures with Santreva-ATK Endovascular Revascularization Catheter
Santreva-ATK is the world’s first wire-free, external power-free, intraplaque chronic total occlusion (CTO) crossing and one-step vessel preparation platform for femoropopliteal arteries. – Atheroplasty represents a new era in endovascular revascularization of complex lesions in severely stenosed vessels, including CTOs – Now available in Europe; U.S. launch planned for October […]
AVS Quadruples Capacity in Preparation for U.S. Commercial Launch with New Headquarters in Waltham, Mass.
New global HQ features over 37,000 square feet that includes R&D and manufacturing BOSTON–(BUSINESS WIRE)–Amplitude Vascular Systems (AVS), a medical device company focused on safely and effectively treating severely calcified arterial disease, announced today the opening of its new global headquarters at 180 Third Avenue in Waltham, Mass. The new 37,811 […]
Miocrbot Medical® CEO to Discuss Recent FDA Clearance of the LIBERTY® Endovascular Robotic System
Livestream Interview Can be Viewed on September 24th at 10:45am ET at Benzinga All Access Live Livestream Interview Can be Viewed on September 24th at 10:45am ET at Benzinga All Access Live
Jupiter Endovascular wins 510(k) FDA clearance for Vertex catheter
Jupiter Endovascular’s Vertex™ Catheter just received 510(k) clearance for the insertion of endovascular devices. This technology adopts Transforming Fixation (TFX) — able to shift from flexible to firm on demand, giving physicians true stability and control. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252027



