Amplifi Vascular, Inc., has been granted Breakthrough Device Designation and Category B assignment from the Centers for Medicare & Medicaid Services (CMS) for the Amplifi Vein Dilation System. This ...

Amplifi Vascular, Inc., a developer of solutions for hemodialysis vascular access, announced it has been granted Breakthrough ...

Ceribell’s LVO Stroke is underpinned by the same EEG monitoring technology used in its seizure and delirium monitoring ...

Amplifi Vascular announced that it received breakthrough device designation for its Amplifi Vein Dilation System.

Currently, the MyoRegulator® device is under investigation as a non-invasive treatment for ALS in a second and larger clinical trial, the CALM ( C ontrolling A myotrophic L ateral Sclerosis M otor ...

FDA Breakthrough designation supports development of a point-of-care test for detecting folate receptor autoantibodies ...

The Skincubator is a wearable designed to enable immediate, prolonged skin-to-skin care for the tiniest preterm infants in ...

Ceribell announced today that the FDA granted breakthrough device designation for its large vessel occlusion (LVO) stroke ...

Boston, MA and Providence, RI, Dec. 17, 2025 (GLOBE NEWSWIRE) -- PathMaker Neurosystems Inc. (“PathMaker”), a clinical-stage neurotechnology company developing a breakthrough non-invasive approach for ...

SECAUCUS, N.J., Aug. 25, 2025 /PRNewswire/ -- Quest Diagnostics (NYSE: DGX), a leading provider of diagnostic information services, today announced that the U.S. Food and Drug Administration (FDA) has ...

TAMPERE, Finland, Dec. 14, 2025 /PRNewswire/ -- Bioretec Oy ("Bioretec" or the "Company"), a pioneer in biodegradable orthopedic implants, has been granted Breakthrough Device Designation by the U.S.

Avvio Medical, Inc., a clinical-stage medical device company developing next-generation kidney stone treatment technologies, today announced that the U.S. Food and Drug Administration (FDA) has ...