Microcatheter-delivered device provides fast and focal occlusion of peripheral arterial targets ALISO VIEJO, Calif., March 5, 2020 /PRNewswire/ — Okami Medical Inc., a medical device company, announced today the successful completion of the first cases with the LOBOTM Vascular Occlusion System. The first offering in the company’s product portfolio, LOBO-3, recently received 510(k) […]
Peripheral/Endo
Reflow Medical Announces 510(k) Clearance for an Expanded Indication for the Wingman Catheter to Cross Chronic Total Occlusions (CTOs) in Peripheral Artery Disease
SAN CLEMENTE, Calif.–(BUSINESS WIRE)–Reflow Medical, Inc., a California-based medical device company, has announced that they have received clearance from the FDA for an expanded indication for the Wingman™ Crossing Catheter after completing the Wing-IT clinical trial. The Wingman Catheter crosses peripheral CTOs using an extendable beveled tip that creates a […]
Access Vascular Receives FDA Clearance For Its HydroPICC Catheter
The HydroPICC Uses Proprietary Technology Designed to Reduce Thrombosis BEDFORD, Mass., Feb. 22, 2018 /PRNewswire/ — Access Vascular, a medical device company reinventing venous access using proprietary material technology designed to reduce thrombus accumulation, announced today that the Company has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its […]
Ra Medical Systems Announces Enrollment of First Patient in Pivotal Atherectomy Clinical Study
CARLSBAD, Calif.–(BUSINESS WIRE)–Ra Medical Systems, Inc. (NYSE: RMED), a medical device company focused on commercializing excimer laser systems to treat vascular and dermatological diseases, announces enrollment of the first patient in its pivotal study to evaluate the safety and effectiveness of the DABRA excimer laser system for use as an […]
Gore Innovation Center Announces Collaboration With Robotics Startup Moray Medical
Startups join Gore Innovation Center to bring new technologies to market. SANTA CLARA, Calif., Feb. 26, 2020 /PRNewswire/ — The Gore Innovation Center today announced a collaboration with Moray Medical, a 2-year-old startup developing precision automated delivery systems for endovascular procedures. The Gore Innovation Center collaboration with Moray Medical is aimed at fundamentally improving the […]
Fist Assist Announces CE Mark and European Launch
LOS ALTOS HILLS, Calif.–(BUSINESS WIRE)–Fist Assist Devices, LLC, has received CE Mark and has begun marketing the Fist Assist device for vein enhancement and enlargement in the European Union and other CE Mark countries. Fist Assist is the only wearable, patent protected, intermittent compression device to increase vein diameter prior […]
Merit Medical Systems Announces Four Regulatory Approvals
SOUTH JORDAN, Utah, Feb. 20, 2020 (GLOBE NEWSWIRE) — Merit Medical Systems, Inc. (NASDAQ: MMSI), a leading manufacturer and marketer of proprietary disposable devices used primarily in cardiology, radiology and endoscopy, announced today that regulatory clearances have been issued with respect to four products Merit owns or holds the rights […]
RIST Neurovascular, Inc. Announces FDA Clearance of the First Catheter Specifically Designed to Access the Neurovasculature through the Radial Artery
RIST Cath device enables a radial approach during neurointerventional procedures for introduction of devices into the neurovasculature MIAMI BEACH, Fla.–(BUSINESS WIRE)–RIST Neurovascular, Inc., a neuro-interventional medtech company, today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance to market the RIST Cath Radial Access Long Sheath™ (RIST […]
FDA Grants De Novo Clearance to Bluegrass Vascular Technologies for the Surfacer® Inside-Out® Access Catheter System
First device to reliably and repeatedly achieve central venous access from the inside-out in patients with venous obstructions SAN ANTONIO, Feb. 11, 2020 /PRNewswire/ — Bluegrass Vascular Technologies (Bluegrass Vascular), a private medical technology company focused on innovating lifesaving devices and methods for vascular access procedures, announced today that the U.S. Food and Drug […]
JanOne strikes agreement with CoreRx, a leading cGMP contract manufacturer, for Phase 2b clinical formulation and development
JanOne’s lead drug clinical candidate TV1001SR to treat PAD and associated pain will be manufactured by CoreRX Pharma with phase 2b trials expected to begin Q4 2020 LAS VEGAS, Feb. 6, 2020 /PRNewswire/ — JanOne Inc. (NASDAQ: JAN), a company focused on bringing treatments to market for conditions that cause severe pain and drugs […]



