Browsing Tag
U.S. Food and Drug Administration
166 posts
C2N Diagnostics wins FDA clearance for PrecivityAD2 as Alzheimer’s blood testing race widens
C2N Diagnostics has secured FDA clearance for PrecivityAD2, extending regulated Alzheimer’s blood testing to symptomatic adults as young as 40 and intensifying competition with established diagnostic platforms.
OncoSil wins FDA HDE approval for rare bile duct cancer treatment
OncoSil Medical has received U.S. FDA Humanitarian Device Exemption approval for the OncoSil System in unresectable, non-metastatic distal cholangiocarcinoma, opening its first U.S. commercial pathway.
Johnson & Johnson clears MONARCH QUEST 3 as bronchoscopy software race accelerates
Johnson & Johnson has secured U.S. 510(k) clearance for MONARCH QUEST 3, adding AI-based nodule segmentation, navigation upgrades and wider cone-beam CT compatibility to its robotic bronchoscopy platform.
Vitestro wins FDA De Novo authorization for Aletta robotic blood draw system
Vitestro’s Aletta has become the first standalone robotic blood-draw device authorized by the FDA, opening a new medtech category built around autonomous outpatient phlebotomy.
Perimeter Medical Imaging AI places Claire at hospitals while recurring legacy revenue rises 31%
Perimeter Medical Imaging AI improved Q2 operating performance and began deploying its FDA-approved Claire system, although all $503,000 of quarterly revenue still came from its legacy S-Series business.
Fulcrum Therapeutics agrees reverse merger with Slate Medicines and $270m dividend
Fulcrum's $270m dividend and 5% stub hand Slate a Nasdaq listing, but SLTE-1009's PACAP bet must beat CGRP incumbents to justify a $350m valuation.
NIH backs Greenstone Biosciences iPSC and AI programme for Duchenne cardiomyopathy
Greenstone Biosciences has secured a National Institutes of Health R61 award to discover potential treatments for cardiac fibrosis and dilated cardiomyopathy in Duchenne muscular dystrophy, extending its patient-derived stem-cell drug discovery strategy into one of the disease’s most consequential complications.
Corbus Pharmaceuticals (NASDAQ: CRBP) lands FDA clearance for TEMPO-1 as CRB-701 enters Phase 3
CRB-701 delivered a 42.9% ORR in 2L OPSCC. Corbus Pharmaceuticals must now reproduce it in a 250-patient TEMPO-1 trial that starts enrolling in September.
Could D-PLEX100 turn surgical infection prevention into a breakout story for PolyPid?
PolyPid’s Azurity deal gives D-PLEX100 a U.S. and Canada launch path, with PYPD investors watching FDA acceptance and 2027 approval timing.
Samsung’s new Galaxy watches promise deeper health insights, but can they revive its wearable momentum?
Samsung Electronics is positioning the Galaxy Watch Ultra2 and Galaxy Watch9 as continuous health platforms, combining longer battery life, new cardiovascular and recovery insights, and a clearer split between everyday wellness and specialist outdoor performance.