JD Supra

FDA Signals Major Shift for QMSR Transition for Medical Device Applications

Drug & Device Team provides recommendations based on Food & Drug Administration (FDA) draft guidance on Quality Management System ...
BioSpace

Sirona Medical Receives FDA 510(k) Clearance for Advanced Imaging Suite, Expanding Class II Medical Device Functionality and PET-CT Capabilities

SAN FRANCISCO, Oct. 30, 2025 /PRNewswire/ -- Sirona Medical today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Sirona Advanced Imaging Suite, marking ...
Hosted on MSN

Unicycive Therapeutics Updates FDA Application for OLC

Take advantage of TipRanks Premium at 50% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence. Unicycive Therapeutics ( (UNCY)) just ...
vietreader.com

FDA Grants Fast Track Designation for AJ201, a First-in-Class Therapy for Kenndy's Disease

TAIPEI, Oct. 23, 2025 /PRNewswire/ -- AnnJi Pharmaceutical Co., Ltd. (AnnJi, TWSE: 7754) today announced that the U.S. Food & Drug Administration (FDA) has granted Fast Track Designation for AJ201, ...
globalcosmeticsnews

FDA Classifies Neutrogena Makeup Remover Wipes Recall as Class II Health Risk Over Bacterial Contamination

THE WHAT? The U.S. Food and Drug Administration (FDA) has classified the recall of Neutrogena Makeup Remover Ultra-Soft Cleansing Towelettes as a Class II health risk following the detection of ...
New Food Magazine

FDA expands egg recall, upgrades to Class I amid salmonella risk

FDA widens recall of Black Sheep Egg Company products, upgrading warning to Class I after salmonella detected during facility inspection. The US Food and Drug Administration (FDA) expanded its recall ...
Healio

FDA accepts supplemental new drug application for leniolisib for children with APDS

Please provide your email address to receive an email when new articles are posted on . There is no current treatment for children with APDS aged 4 to 11 years. Diagnostic delays have a mean of 7 ...
Morningstar

Rhythio Medical Receives FDA Breakthrough Device Designation for Injectable Electrode Technology Enabling Painless, Imperceptible Defibrillation

Rhythio Medical’s soft, conductive hydrogel technology transforms traditional defibrillation into a new class of injectable bioelectronic therapy Rhythio Medical, a medical device company pioneering ...