Regulatory

Israeli startup Sanolla receives FDA clearance for the world’s first AI-ready infrasound stethoscope

Sanolla’s pioneering technology draws lifesaving medical insights from listening to bodily sounds that cannot be heard by humans The startup’s AI algorithms provide unmatched disease classification for many cardiopulmonary diseases including COPD, pneumonia, asthma, and cardiac morbidities NESHER, Israel, April 11, 2022 /PRNewswire/ […]

Aziyo Announces FDA 510(k) Submission for CanGaroo® RM, its Next-Generation Biomaterial Envelope Enhanced with Antibiotics

SILVER SPRING, Md., April 04, 2022 (GLOBE NEWSWIRE) — Aziyo Biologics, Inc. (Nasdaq: AZYO), today announced the Company has filed a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for CanGaroo® RM Antibacterial Envelope, its next-generation biomaterial envelope […]

FEops HEARTguide Receives FDA Clearance for LAAo Planning Capabilities

GENT, Belgium–(BUSINESS WIRE)–FEops today announced that it received authorization from the U.S. Food and Drug Administration (FDA) for FEops HEARTguide™ pre-operative planning of left atrial appendage occlusion (LAAo) with the Abbott’s Amplatzer™ Amulet™ and Boston Scientific’s Watchman FLX™ device*. FEops HEARTguide […]

Radiaction Medical Ltd. Receives FDA Clearance for its Innovative Radiation Protection System and Secures $10M for US Launch and Commercialization

TEL AVIV, Israel, March 31, 2022 /PRNewswire/ — Radiaction Medical Ltd. (“Radiaction”), an innovative medical device company focused on radiation protection in the interventional cardiology and electrophysiology sectors, announced FDA 510(K) clearance for the marketing of its Shield System in the US. In addition, […]

Cook Medical receives FDA Breakthrough Device Designation for Zenith® Thoraco+ Endovascular System

Bloomington, Ind. — Cook Medical’s Zenith® Thoraco+ Endovascular System (Thoraco+) has received Breakthrough Device Designation from the US Food and Drug Administration (FDA). This designation is granted to devices that have the potential to provide more effective treatment or diagnosis for life-threatening […]