Tag: FDA

DiA Granted FDA Clearance for its Cardiac Ultrasound AI Auto Views Selection

This 7th FDA clearance further solidifies DiA’s leadership in the ultrasound AI space. BE’ER SHEVA, Israel, Oct. 29, 2020 /PRNewswire/ — DiA Imaging Analysis announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the commercial use of LVivo Seamless for automatic view selection. LVivo Seamless algorithms automatically […]

Neovasc Announces FDA Advisory Panel Result on Neovasc Reducer™ Medical Device for the Treatment of Refractory Angina

VANCOUVER and MINNEAPOLIS, Oct. 28, 2020 (GLOBE NEWSWIRE) — via NewMediaWire — Neovasc Inc. (“Neovasc” or the “Company”) (NASDAQ, TSX: NVCN) today announced that the United States Food and Drug Administration’s (FDA’s) Circulatory System Devices Advisory Panel voted 14 to 4 “in favor” that the Neovasc Reducer™ is safe when used as intended, and voted 1 to […]

Foldax Receives FDA Approval to Expand Clinical Study of Novel Biopolymer Aortic Heart Valve

SALT LAKE CITY–(BUSINESS WIRE)–Foldax®, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted approval to expand the U.S. clinical study of the Tria™ surgical aortic heart valve. This next stage of enrollment is expected to begin within the next month. “We are excited to expand enrollment […]

FDA Grants 510(k) Clearance for Abiomed’s Innovative Cardiopulmonary Support Technology

DANVERS, Mass.–(BUSINESS WIRE)–The United States Food and Drug Administration (FDA) has granted Abiomed (NASDAQ: ABMD) a 510(k) clearance for an all-in-one, compact cardiopulmonary bypass system called the Abiomed Breethe OXY-1 System™. The ECMO system provides cardiopulmonary bypass support for patients whose lungs can no longer provide sufficient end organ oxygenation. The 510(k) clearance […]

Aidoc granted AI industry-first FDA clearance for triage of incidental pulmonary embolism

This is the company’s 6th FDA clearance and further solidifies its leadership as the most comprehensive acute AI vendor in the market NEW YORK, Oct. 21, 2020 /PRNewswire/ — Aidoc announced today that the US Food and Drug Administration (FDA) has given regulatory clearance for the commercial use of its triaging and notification algorithms […]

Nation’s First Implant of Bluetooth-Connected Heart Device at St. Elizabeth

EDGEWOOD, Ky., Oct. 15, 2020 /PRNewswire/ — Dr. Mohamad Sinno recently performed the first implantation in the U.S. of a Bluetooth-enabled biventricular implantable cardiac defibrillator (ICD) at St. Elizabeth Edgewood. The new device, the Abbott Gallant, recently received FDA approval for a new technology assessment and is available in only a few centers in the U.S. […]

Medtronic Receives FDA “Breakthrough Device Designation” for TYRX Driveline Wrap Device

DUBLIN, Sept. 22, 2020 /PRNewswire/ — Medtronic plc (NYSE:MDT), the global leader in medical technology, has received Breakthrough Device Designation status from the U.S. Food and Drug Administration (FDA) for the TYRX™ Absorbable Antibacterial Driveline Wrap, which is intended to securely hold a percutaneous driveline in patients receiving a ventricular assist device (VAD). […]

Surmodics Receives FDA 510(k) Clearance for Pounce™ Thrombus Retrieval System

Next-generation technology provides easy, effective clot removal from peripheral arterial vasculature EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–Surmodics, Inc. (NASDAQ:SRDX), a leading provider of medical device and in vitro diagnostic technologies to the health care industry, announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Pounce™ Thrombus Retrieval System. […]

Medtronic Receives Breakthrough Device Designation from FDA, Begins Early Feasibility Study…

Medtronic Receives Breakthrough Device Designation from FDA, Begins Early Feasibility Study for Investigational Intrepid™ Transcatheter Valve System for the Treatment of Tricuspid Valve Regurgitation DUBLIN, Sept. 9, 2020 /PRNewswire/ — Medtronic plc (NYSE:MDT), a global leader in structural heart therapies, today announced U.S. Food and Drug Administration (FDA) approval of an early feasibility […]

PQ Bypass Receives FDA “Breakthrough Device Designation” for the World’s First Fully Percutaneous Femoral-Popliteal Bypass Device

Designation Expedites Physician Access to Device for Patients with Extremely Long and Complex SFA Lesions MILPITAS, Calif.–(BUSINESS WIRE)–PQ Bypass Inc, a medical device pioneer bringing new advancements to the treatment of advanced peripheral artery disease (PAD), announced today that they received Breakthrough Device designation from the U.S. Food and Drug […]