News

Endovascular Today17h
Imperative Care Zoom 7X Catheter for Ischemic Stroke Cleared by FDA
Imperative Care, Inc. announced the FDA 510(k) clearance of and first patient cases with its Zoom 7X catheter for aspiration ...
Fierce Pharma12h
FDA delays Blenrep decision, putting GSK's multiple myeloma comeback dreams on ice
Just when the future looked bleak for GSK’s Blenrep comeback in the U.S., the FDA has blessed the company's multiple myeloma ...
MassDevice14h
Elekta wins expanded FDA nod for Gamma Knife radiosurgery system
Elekta announced today that it received FDA 510(k) clearance to expand indications for its Leksell Gamma Knife radiosurgery ...
Zacks Investment Research on MSN18h
Tempus AI Gains FDA Nod Amid Booming AI ECG Market Momentum
The integration of artificial intelligence (AI) in the cardiovascular space, particularly in electrocardiography (ECG), is reshaping clinical workflows, enabling earlier disease detection and opening ...
Oncoustics Announces Initiation Of FDA-Supervised Study Of The Onx Liver Assessment Solution At Multiple Clinical Sites
Oncoustics Oncoustics initiates FDA study of the OnX Liver Assessment Solution at clinical sites across the US and Canada marking a milesto ...
Quest to offer Fujirebio’s FDA-cleared Alzheimer’s blood test
The company plans to make the diagnostic available to physicians and researchers this summer, expanding its portfolio beyond ...
Becker's Spine Review18h
Spectrum Spine’s lumbar cages earn FDA clearance
Spectrum Spine earned FDA 510(k) clearance for its family of lumbar cage implants, according to a July 22 news release. The implants use BioBraille surface treatment on the bone contact areas and ...
New FDA-cleared implant 'revolutionizing' shoulder replacement surgery
"It's called an alternate bearing surface, called Pyrocarbon," said Dr. E. Scott Paxton with University Orthopedics.
dvm3601d
FDA approves first generic methimazole tablet for feline hyperthyroidism
This latest approval builds on an earlier liquid formulation of generic methimazole for feline hyperthyroidism, which ...
STAT12d
FDA grants full approval to Moderna’s Covid vaccine for children but limits eligibility
Moderna’s Covid vaccine for children has been given full FDA approval, making it the first such shot for kids in the U.S.
Becker's Hospital Review6y
First FDA-cleared ‘digital therapeutic’ for opioid use disorder debuts
Pear Therapeutics and Sandoz, a division of pharmaceutical company Novartis, launched reSET-O, a digital therapeutic for opioid use disorder, Jan. 7. The FDA cleared reSET-O in December, making it ...
Becker's Spine Review1d
SurGenTec earns additional FDA clearance for spinal bone graft
SurGenTec earned additional FDA clearance for its OsteoFlo HydroFiber, according to a July 22 news release. The new 510(k) clearance adds indications for use as a bone void filler for the treatment of ...