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 ...
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 ...
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 ...

Ceribell Receives FDA Breakthrough Device Designation for LVO Stroke Detection and Monitoring Solution

Clearance would position the Ceribell System as the first and only point-of-care electroencephalography (EEG) technology to ...

Protara, Ceribell rise on FDA breakthrough designations

Protara Therapeutics (TARA) and CeriBell (CBLL) were among the notable healthcare gainers on Monday after the FDA issued ...
MarketWatch

Nanopath Granted FDA Breakthrough Device Designation for Its Molecular Diagnostic Platform for Urinary Tract Infections

The MarketWatch News Department was not involved in the creation of this content. Milestone clears path for rapid market entry of Nanopath's first-in-class point-of-care platform addressing a leading ...
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 ...
Morningstar

Avvio Medical Receives FDA Breakthrough Device Designation for the Avvio Enhanced Lithotripsy System (ELS)

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 ...
Nasdaq

Bioretec Secures FDA Breakthrough Device Designation For RemeOs DrillPin

(RTTNews) - Bioretec Oy (0TN.F, BRETEC.HE) has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for its magnesium alloy technology-based, biodegradable ...
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 ...