The Latest Cardiac and Vascular News
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 approval from the U.S. Food and Drug Administration (FDA) that the Company has provided sufficient data to support initiating an investigational device exemption (IDE) to […]
– APD418 currently in Phase 1 clinical investigation – data expected this year SAN DIEGO, Jan. 16, 2020 /PRNewswire/ — Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) today announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for APD418, a β3-adrenergic receptor (AdrR) antagonist and cardiac myotrope, in development for the treatment of […]
SAN CARLOS, Calif., Jan. 14, 2020 (GLOBE NEWSWIRE) — BioCardia®, Inc. [OTC: BCDA], a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the Morph® DNA deflectable guide catheter used to guide the Helix™ Biotherapeutic Delivery System […]
– New clinical trial will assess first-of-its-kind MitraClip™ transcatheter mitral valve repair against current standard of care surgery in a new, expanded patient population – If successful, the REPAIR MR study has potential to expand MitraClip’s current indication (patients at prohibitive risk for surgery) to also include patients at moderate […]
SAN CLEMENTE, Calif.–(BUSINESS WIRE)–Reflow Medical announces that the Temporary Spur Stent System, a novel retrievable stent technology intended for the treatment of below-the-knee (BTK) peripheral artery disease, has been designated for the Breakthrough Devices Program by the U.S. Food and Drug Administration (FDA). The Breakthrough Devices Program is designed to […]
JenaValve Pericardial TAVR System is the First Transcatheter Device to Achieve Breakthrough Device Designation; Prioritizes Premarket Approval Development Path for Severe Aortic Regurgitation Indication IRVINE, Calif.–(BUSINESS WIRE)–JenaValve Technology, Inc., developer and manufacturer of the JenaValve Pericardial transcatheter aortic valve replacement (TAVR) system for the treatment of aortic valve disease, announced […]
SALT LAKE CITY–(BUSINESS WIRE)–Alucent Biomedical Inc. has received U.S. Food and Drug Administration approval to proceed with a Phase 1 clinical trial to evaluate the safety and efficacy of its revolutionary Natural Vascular Scaffolding (NVS) technology. The therapy is designed to treat peripheral artery disease (PAD) of the lower extremities, a […]
ALAMEDA, Calif.–(BUSINESS WIRE)–Penumbra, Inc. (NYSE: PEN), a global healthcare company focused on innovative therapies, today announced U.S. Food and Drug Administration 510(k) clearance for expanded indication of the Indigo® Aspiration System. As part of the Indigo Aspiration System, the Indigo Aspiration Catheters and Separators are indicated for the removal of fresh, […]
Aliso Viejo, CA. – January 9, 2020 –MicroVention, Inc., a U.S. based subsidiary of Terumo and a global neurovascular company announced the FDA Premarket Approval (PMA) for the FRED® (Flow Re-Direction Endoluminal Device) device for the treatment of brain aneurysms. The FRED® device is the first flow diverter in the U.S. to use […]
FDA confirms no plan to inform patients of non-exempt medical devices placed in 667 citizens. SHEBOYGAN, Wis., Jan. 9, 2020 /PRNewswire/ — Following recent reporting by Kaiser Health News that the FDA has lifted their exemption laws, Dr. Nalini Rajamannan a specialist for patients with valvular heart disease in Most Sacred Heart of Jesus Cardiology, […]
