Regulatory

Corvia Medical Completes Randomization In REDUCE LAP-HF II Pivotal Trial And Gains FDA Authorization To Provide Continued Access For The Corvia Atrial Shunt

Large randomized, sham-controlled trial evaluates interatrial shunting in a heart failure population currently without effective treatment TEWKSBURY, Mass., Nov. 17, 2020 /PRNewswire/ — Corvia Medical, Inc., a company dedicated to transforming the treatment of heart failure (HF), today announced completion of randomization in its REDUCE LAP-HF II global, pivotal trial. The trial […]

TISSIUM Receives FDA Investigational Device Exemption for Vascular Sealant

IDE Approval Clears Path to U.S. Clinical Trial Launch for Vascular Sealant PARIS–(BUSINESS WIRE)–TISSIUM, a privately-owned medtech company developing biomorphic programmable polymers for tissue reconstruction, announced today it has received approval from the U.S. Food and Drug Administration for its Investigational Device Exemption application for its vascular sealant. The approval […]

Nanowear Receives FDA 510(k) Clearance for SimpleSENSE, a Cloth-Based Wearable Remote Diagnostic Monitoring Platform

SimpleSENSE provides a continuous, simultaneous, and synchronous assessment of the heart, lungs, and upper vascular system without the need for an in-person doctor’s visit NEW YORK, Nov. 11, 2020 /PRNewswire/ — Nanowear www.nanowearinc.com, the leading connected-care and remote diagnostic platform, today announced it has received FDA Class II 510(k) clearance for a first-of-its-kind cloth-based […]

Boston Scientific Receives FDA Approval for the Ranger™ Drug-Coated Balloon

Company provides physicians with first portfolio comprised of drug-eluting stent and drug-coated balloon for the treatment of patients with peripheral artery disease MARLBOROUGH, Mass., Nov. 2, 2020 /PRNewswire/ — Boston Scientific (NYSE: BSX) announced it has received U.S. Food and Drug Administration (FDA) approval of the Ranger™ Drug-Coated Balloon, developed for the treatment […]

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 […]

FLEX Vessel Prep™ System Receives New Indication to Address In-Stent Restenosis

MINNEAPOLIS, Oct. 21, 2020 /PRNewswire/ — VentureMed Group, Inc. (VentureMed), a privately-held medical device innovator in vessel preparation for interventional treatment of peripheral arterial disease (PAD) and stenoses of arteriovenous (AV) fistulas and grafts, announced today that the U.S. Food and Drug Administration (FDA) cleared the Company’s FLEX Vessel Prep™ System for use in […]

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 […]