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 ...
JD Supra3d
CMS's New TCET Pathway Expedites Medicare Coverage for FDA Breakthrough Devices
The Centers for Medicare and Medicaid Services ("CMS") published a final notice outlining the processes and procedures for the Transitional ...
FDA Approves Blood Test for Alzheimer's Disease
The FDA has granted medical manufacturer Beckman Coulter a Breakthrough Device Designation for its new plasma ratio, a blood ...
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, 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).
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 ...
FDA review designations: tracking 40 years of innovation
The rising trend mirrors the evolution of the pharma industry in terms of investment and utilisation of novel technologies.
emjreviews.com12d
FDA fast-tracks brelovitug for treatment of chronic hepatitis D
The drug has been granted Breakthrough Therapy designation by the FDA for the treatment of chronic hepatitis delta (CHD).
Medscape2d
FDA OKs First-In-Class Nonopioid Pain Med Suzetrigine
Suzetrigine selectively inhibits the NaV1.8 pain-signaling pathway in the peripheral nervous system and provides effective ...
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 ...
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 ...