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/ […]
Regulatory
Triastek Receives FDA IND Clearance for 3D Printed Product of Blockbuster Molecule
NANJING, China, April 7, 2022 /PRNewswire/ — Triastek, Inc. (“Triastek”) recently announced that the United States Food and Drug Administration (FDA) has granted permission to begin clinical studies of its Investigational New Drug (IND) 505(b)(2) application for a 3D printed drug product – T20. […]
Arterys Receives Its Eighth FDA Clearance Powered With AI and Releases Its Next-Generation Cardio AI Application
Receives eighth FDA clearance, releases its next-generation Cardio AI application SAN FRANCISCO, April 07, 2022 (GLOBE NEWSWIRE) — Arterys, the world’s leading vendor-neutral AI platform, has announced several new modules to its already robust Cardio AI clinical application and an […]
Zio® by iRhythm Shown to Prevent Hospital Admissions, Aid in Early Detection of AF
New clinical research presented at ACC.22 shows that the Zio service is a viable solution for the early detection of silent atrial fibrillation Additional data shows that Zio AT can positively impact hospital resources – saving one healthcare system 136 inpatient […]
ABBOTT RECEIVES FDA APPROVAL FOR AVEIR™ VR LEADLESS PACEMAKER SYSTEM TO TREAT PATIENTS WITH SLOW HEART RHYTHMS
Abbott’s Aveir single chamber (VR) pacing system is the world’s only leadless pacemaker with a unique mapping capability to assess correct positioning prior to placement Aveir VR has an increased projected battery life that can be up to two times […]
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, […]
EDWARDS MITRIS RESILIA VALVE RECEIVES FDA APPROVAL FOR MITRAL REPLACEMENT SURGERIES
IRVINE, Calif., March 31, 2022 /PRNewswire/ — Edwards Lifesciences (NYSE: EW) today announced it received approval from the U.S. Food and Drug Administration (FDA) for the MITRIS RESILIA valve, a tissue valve replacement specifically designed for the heart’s mitral position. The MITRIS RESILIA […]
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 […]