bernama10h
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 ...
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).
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 ...
Monthly Prescribing Reference13d
Brelovitug Granted Breakthrough Designation for Chronic Hepatitis Delta
Findings showed patients treated with brelovitug achieved 100% virologic response on all dosing arms. The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to ...
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 ...
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 ...
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 ...
Business Insider27d
Rezolute Receives Breakthrough Therapy Designation from FDA for Ersodetug in the Treatment of Hypoglycemia Due to Congenital Hyperinsulinism
Breakthrough Therapy Designation granted based on key positive data from the Phase 2b (RIZE) study and current unmet medical need in congenital hyperinsulinism (HI) Ersodetug continues to advance ...
Healio12d
Bluejay Therapeutics’ brelovitug secures FDA breakthrough status for chronic HDV
The FDA has granted breakthrough therapy designation to Bluejay Therapeutics’ brelovitug for the treatment of chronic hepatitis delta, for which no approved therapies currently exist in the U.S., the ...