Where FDA breakthrough devices stand through 2025: growth, authorizations, leading specialties, AI trends, and qualification pathways explained.

FDA grants Breakthrough Device Designation to BioAgilytix’s anti-AAV antibody assay supporting Lexeo’s gene therapy for ...

The FDA has granted breakthrough device designation for an implantable insulin pump designed for people with type 1 diabetes, according to an industry press release. The implantable device (Portal ...

Orthopedics was the most active area over the second half of 2025, with the FDA issuing 13 breakthrough designations to devices in the therapeutic area.

Designation highlights GeneDx innovation in clinical whole genome and whole exome testing and accelerates the pathway for FDA authorization of these novel diagnostic tests With more than 2.5 million ...

Portal Diabetes has received Breakthrough Device Designation by the Food and Drug Administration (FDA) for its implantable insulin pump system called Portal Pump, and the start of ...

Breath Diagnostics, Inc., a leader in breath-based molecular diagnostics powered by patented microreactor capture technology, is pleased to announce that the U.S. Food and Drug Administration (FDA) ...

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 ...

NEW YORK, NY, UNITED STATES, January 12, 2026 /EINPresswire.com/ — Micoy Therapeutics today announced that the NeuroLume™ Test has been granted Breakthrough ...

(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 ...

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 ...

SANTA MARIA, Calif. and GUIPRY, France, Feb. 18, 2026 /PRNewswire/ -- In a major step forward against Antimicrobial ...