bernama15h
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 ...
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 ...
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).
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 ...
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 ...
Danaher’s Strategic Positioning and Breakthrough in Alzheimer’s Diagnostics Market Justifies Buy Rating
Leerink Partners analyst Puneet Souda has maintained their bullish stance on DHR stock, giving a Buy rating yesterday.Invest with Confidence: ...
Healio13d
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 ...