Restore Medical has secured the US Food and Drug Administration’s (FDA) breakthrough device designation for its ContraBand system to treat left ventricle (LV) failure.
The...
Positrigo, a Swiss based company developing nuclear medical imaging devices to advance functional brain imaging, has achieved a significant milestone with the U.S. Food...
Providence Medical Technology has received clearance from the US Food and Drug Administration (FDA) for its CORUS Posterior Cervical Stabilization System (PCSS), designed to...
Medical Microinstruments announced it hit significant commercial milestones for its surgical robot across two continents. The company develops the Symani surgical robot system, which...
Orthofix received FDA 510(k) clearance for the Fitbone Transport and Lengthening System and reported the first implant of the device. The Lewisville, Texas–based company...
Pulse Biosciences (Nasdaq:PLSE) announced today that the FDA granted breakthrough device designation for its pulsed field ablation system. Shares of PLSE rose more than...
Medical imaging company Avicenna.AI has secured Medical Device Regulation (MDR) certification for five of its AI algorithms which are used to screen severe conditions.
Avicenna.AI’s...
Signum Surgical has secured De Novo clearance from the US Food and Drug Administration (FDA) for its BioHealx technology for anal fistula treatment.
BioHealx is...
Brain-computer interface (BCI) developer Paradromics announced today that the FDA accepted it into its Total Product Life Cycle Advisory Program (TAP). TAP provides early...
