Regulatory Approvals

Microbot Medical Inc. has announced the first steps towards its planned European market clearance, by engaging with a leading Notified Body. The Notified Body will audit...

Imperative Care, a medical technology company developing connected innovations to elevate care for people affected by stroke and other ischemic diseases, announced U.S. Food...

Inspira™ Technologies OXY B.H.N. Ltd. (Nasdaq: IINN, IINNW) (the "Company" or "Inspira Technologies"), a company aiming to revolutionize acute respiratory care, is proud to announce it...

Certification reinforces STORZ & BICKEL's leadership position in medical device design, ensures continued availability of devices worldwide STORZ & BICKEL GmbH ("STORZ & BICKEL"), the...

ReddyPort announced today that the US Food and Drug Administration (FDA) granted 510(k) premarket clearance for the ReddyPort elbow device used in non-invasive ventilation...

The Ohio-based company's XR90 offering allows physicians to view a patient's anatomical structures in 3D for preoperative and intraoperative use. MediView XR, a medtech company...

This FDA-cleared wearable neuromodulation system offers game-changing access for patients to start the road to recovery without interruptions to daily living. Spark Biomedical, Inc., a...

Koru Medical Systems (Nasdaq:KRMD) announced that it submitted its Freedom60 infusion system for FDA 510(k) clearance. The submission covers the use of the Freedom60 infusion system...

BIOTRONIK  announced U.S. Food and Drug Administration (FDA) approval of its portfolio of Amvia Edge pacemakers and cardiac resynchronization therapy pacemaker (CRT-P), its latest...