Regulatory Approvals

EchoGo® Heart Failure revolutionizes the detection of HFpEF – the biggest unmet need in cardiovascular medicine.1 Ultromics’ EchoGo® Heart Failure, an AI solution for echocardiography...

VYRSA Technologies, a specialty medical device firm, announced the FDA clearance of the VYRSA V1™ SI Fusion System. After an extensive two 1/2-year biomechanical...

WISE Cortical Strip is the first cortical strip embedding the electrodes in a highly compliant thin film of silicone to receive FDA clearance The thin...

The new BodyTom 64 scanner has been designed to improve clinical workflows and boost user experience. Samsung Electronics subsidiary NeuroLogica has secured 510(k) clearance for its BodyTom 64 Point-of-Care...

SurgiBox Inc. announced CE Marking for its Smart Control Module 001-SCM-0000 and its Battery Pack BP-04002M. SurgiBox has obtained Humanitarian Use Exemption for the use of...

Persona OsseoTi features Persona anatomic tibia’s new porous version and OsseoTi porous medical technology. Medical technology firm Zimmer Biomet has received 510(k) clearance for its Persona OsseoTi Keel Tibia...

The Parky app monitors tremor and dyskinesia symptoms of Parkinson's Disease patients in real time. h2o therapeutics has secured 510(k) clearance from the US Food and Drug...

LivaNova (Nasdaq: LIVN) says a new FDA clearance expands how long health providers can use its LifeSparc advanced circulatory support (ACS) pump for extracorporeal membrane...

Neocis announced that it received FDA 510(k) clearance for its Yomi surgical robot system for use in guided bone reduction. This represents the second FDA clearance...