Stories and news about FDA breakthrough designation from GeekWire.

The FDA's Breakthrough Devices Program is designed to expedite the development, assessment, and review of medical devices that can provide significant improvements over current treatment options.

The US Food and Drug Administration (FDA) has awarded Neuralink’s brain-computer interface breakthrough device designation for the treatment of individuals with severe speech impairment. The FDA ...

The FDA has approved a DNA-based blood test for cystic fibrosis (Tag-It), an immunoassay for celiac disease (Anti-Tissue Transglutaminase IgG), and a software module (Body Fluids).

Le TGW101 est un diabody liant le TAG-72 conjugué à la toxine de monométhylauristatine E (MMAE). Le TGW101 est administré par voie intraveineuse (IV) en premier et peut se lier au TAG-72 dans ...

The FDA has issued a Breakthrough Therapy tag for AMT-130 as a treatment for Huntington’s disease, a rare neurodegenerative disorder with no FDA-approved disease-modifying therapies.

The FDA has approved a thoracic endoprosthesis (GORE TAG), a peripheral infusion system (Trellis-8), and an expanded indication for a perfusion/flushing solution (Custodiol HTK).

Drugmaker CSL Behring, based in Pennsylvania, announced the $3.5 million price tag shortly after the FDA approval, saying its drug would ultimately reduce health care costs because patients would ...

The FDA is cautioning consumers not to purchase skin tag and mole removal products online and sent warning letters to Amazon, Ariella Naturals and Justified Laboratories for selling the unapproved ...

The FDA tag is a landmark moment for the Elon Musk-owned brain chip developer, affirming the agency’s positive view of the technology’s use cases for people with quadriplegia.