Beckman Coulter Receives FDA Breakthrough Device Designation for Alzheimer's Disease Blood Test
Beckman Coulter Diagnostics, a global leader in clinical diagnostics, today announced the U.S. Food and Drug Administration ...
Modella AI’s Generative AI Co-Pilot PathChat Receives FDA Breakthrough Device Designation
Modella AI, a pioneer in generative and agentic artificial intelligence for biomedicine, is proud to announce that its ...
bernama9h
Modella AI’s PathChat Obtains FDA Breakthrough Device Designation For Advancing Pathology Diagnostic
KUALA LUMPUR, Feb 3 (Bernama) -- Modella AI, a pioneer in generative and agentic artificial intelligence (AI) for biomedicine, has announced that its cutting-edge generative AI co-pilot, PathChat DX, ...
clinicaladvisor.com3d
Brelovitug Granted Breakthrough Designation for Chronic Hepatitis Delta
The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to brelovitug (BJT-778) for the treatment of chronic hepatitis delta (CHD).
GlobalData on MSN12d
FDA breakthrough status for Bluejay’s CHD therapy brelovitug
The US FDA has granted breakthrough therapy designation to Bluejay Therapeutics’ brelovitug, to treat chronic hepatitis delta ...
Morningstar6d
Beckman Coulter Receives FDA Breakthrough Device Designation for Alzheimer's Disease Blood Test
"We are honored to receive Breakthrough Device Designation from the U.S. FDA for our p‑Tau217/β-Amyloid 1-42 assay, a significant step forward in addressing the urgent need for earlier and more ...
medtechdive13d
Irish Neurotech Start-up, CergenX Receives FDA Breakthrough Designation for Wave Device
A CergenX-led consortium, including UCC/ INFANT, was awarded €6.7 million in funding from The Disruptive Technologies ...
The Victoria Advocate13d
IntelliGenome Receives FDA Breakthrough Device Designation for CRISPR-TB Blood Test
"The FDA's Breakthrough Device Designation for our CRISPR-TB Blood Test is a significant milestone for IntelliGenome. This recognition highlights our commitment to advancing innovative, accessible ...