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 ...
JD Supra4d
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 ...
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).
Healio8h
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.
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 ...
MassDevice11d
FDA adds RevMedica stapling platform to STeP program
RevMedica announced that the FDA accepted its Endo stapling platform into its Safer Technologies Program (STeP).
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 ...
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 ...