Regulatory Approvals

 Alio Inc., announced it received FDA 510(k) clearance for its remote monitoring system intended for use by healthcare professionals to intermittently collect physiological data...

Fitbit has received clearance from the US Food and Drug Administration (FDA) for a new photoplethysmography (PPG) algorithm to identify atrial fibrillation (AF). The...

Truvic Medical, Inc., a wholly owned subsidiary of Imperative Care, Inc., announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA)...

Aveir VR leadless pacemaker can determine correct positioning prior to final implantation. The US Food and Drug Administration (FDA) has granted approval for Abbott’s Aveir single-chamber (VR)...

End-tidal Control software helps reduce greenhouse gas emissions and costs by cutting anesthetic agent wasteEnables anesthesia providers to set precise targets for oxygen and...

Aidoc said it has received FDA 510(k) clearance for AI-powered X-ray detection of pneumothorax, also known as a collapsed lung. It’s the latest indication for...

PocDoc has secured a CE mark for its AI driven digital reader of lateral flow tests. The cloud-based system allows any smartphone or tablet...

Microbot Medical Inc. has announced that it has filed its pre-submission package for the LIBERTY® Robotic System with the U.S. Food and Drug Administration (FDA), addressing the regulatory...

Envista Holdings Corporation (NYSE: NVST) ("Envista") -- Envista announced the 510(k) Food and Drug Administration (FDA) clearance of its Assisted Intelligence (AI) mandibular nerve tracing...