GlobalData on MSN

FDA grants breakthrough designation to Ceribell’s stroke detection tool

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

Amplifi Vascular Gains FDA Breakthrough Device Status & CMS Category B

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 ...
Endovascular Today

Amplifi Vein Dilation System Gains FDA Breakthrough Device Designation

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

Amplifi Vascular wins FDA breakthrough nod for vein dilation system

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

Micoy Therapeutics Receives FDA Breakthrough Designation for NeuroLume™ Test to Detect Folate Receptor Autoantibodies

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

Ceribell gets FDA breakthrough nod for stroke detection, monitoring solution

Ceribell announced today that the FDA granted breakthrough device designation for its large vessel occlusion (LVO) stroke ...
Medical Device and Diagnostic Industry (MD+DI)

Skincubator Scores FDA Breakthrough Device Designation

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

CBLL wins FDA breakthrough status for AI-based LVO stroke detection

CeriBell Inc. CBLL recently announced that the FDA has granted Breakthrough Device Designation for its Large Vessel Occlusion ...

Protara, CeriBell rise on FDA breakthrough designations

Protara Therapeutics stock (TARA) and CeriBell stock (CBLL) gain as the FDA issues breakthrough designations for their ...
Morningstar

Inside information: Bioretec has been granted FDA Breakthrough Device Designation status for its RemeOs™ DrillPin

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.
Seeking Alpha

FDA Grants Breakthrough Device Designation for Haystack MRD Circulating Tumor DNA Test from Quest Diagnostics

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 ...