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4C Medical's AltaValve System Secures Dual FDA Breakthrough Device Designations, Expediting Patient...
WFRV 5 Green Bay· 30 minutes agoFood and Drug Administration (FDA) for the AltaValve™ System, a transcatheter mitral valve replacement (TMVR) device. Among other benefits, Breakthrough Device designation ...
Indica Labs Receives First FDA Clearance for HALO AP Dx Digital Pathology Platform
The Kansas City Star· 37 minutes agoHALO AP Dx brings digital primary diagnosis to anatomic pathology labs in the US.
FDA approves CereVasc’s eShunt system study for hydrocephalus
Medical Device Network via Yahoo Finance· 3 hours agoThe US Food and Drug Administration (FDA) has granted investigational device exemption (IDE)...
FDA fast track status granted to iECURE neonatal OTC deficiency treatment
Pharmaceutical Technology via Yahoo Finance· 2 hours agoThe US Food and Drug Administration (FDA) has granted fast track designation for iECURE’s gene...
The FDA misses its own deadline to propose a ban on formaldehyde from hair products
NPR· 4 hours agoThe federal agency proposed the ban in October 2023 and scheduled its implementation for April 2024....
FDA Verdict May Set Precedent for Speedy Gene Drug Approvals
Bloomberg· 3 hours agoHave a confidential tip for our reporters? When my colleague Fiona Rutherford and I wrote our first...
Eating yogurt could help prevent one common disease, according to the FDA
Fox News· 12 hours agoThe U.S. Food and Drug Administration (FDA) has implied that it’s possible. The health agency...
Avidity Biosciences Receives FDA Breakthrough Therapy Designation for Delpacibart Etedesiran (AOC...
FOX40 Sacramento· 3 hours agoFood and Drug Administration (FDA) has granted Breakthrough Therapy designation to delpacibart etedesiran (AOC 1001), the company's lead clinical development program, for ...
FDA issues 510(k) clearance for US Medical Innovations’ ablation system
Medical Device Network via Yahoo Finance· 3 hours agoThe US Food and Drug Administration (FDA) has issued 510k clearance for US Medical Innovations’s...
Eli Lilly Alzheimer’s drug gets FDA panel date after approval delay
The Hill via Yahoo News· 21 hours agoAn outside panel of advisers to the Food and Drug Administration (FDA) will meet next month to...