bernama7h
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 ...
GlobalData on MSN13d
CergenX wins FDA breakthrough designation for neonatal EEG assessment tool
Trained on large databases of brain data among newborns, CergenX’s Wave device uses AI to help with earlier detection of ...
Healio25m
VIDEO: Definition of EGFR-mutated lung cancer continues to expand
In this video, Xiuning Le, MD, PhD, discusses how the definition of EGFR-mutated lung cancer has expanded in recent years.
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).
Yahoo Finance13d
Bluejay Therapeutics Receives U.S. FDA Breakthrough Therapy Designation for Brelovitug (BJT-778) for the Treatment of Chronic Hepatitis Delta
"Breakthrough Therapy designation recognizes the potential of brelovitug to transform the lives of people living with CHD. We ...
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: ...
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 ...
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 ...
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 ...