The US Food and Drug Administration (FDA) has granted special 510(k) clearance to the Zeta Surgical Navigation System, ...

Bayer has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its multi-patient Medrad Centargo computed tomography (CT) injection system. The injection system integrates with ...

Despite needing FDA clearance to be on the shelves of your local pharmacy, some popular medicines probably don't work.

Foundation Surgical earned FDA 510(k) clearance for its Vertiwedge intraosseous device, according to a Nov. 8 news release shared with Becker's ...

Zeta Surgical announced that the FDA granted 510(k) clearance for its Zeta Navigation System for expanded capabilities.

NeurAxis (NYSE:NRXS) announced today that the FDA granted an expanded 510(k) clearance for its IB-Stim non-implanted nerve ...

The FDA recently approved a phase 2 clinical trial to investigate the efficacy of leronlimab in patients with relapsed or ...

Imbed Biosciences receives FDA 510(k) clearance for first antimicrobial wound dressing with integrated lidocaine for painful ...

CytoDyn (CYDY) announced that it has received clearance from the FDA to commence its Phase II oncology trial. The study will evaluate the ...

Quanta Dialysis Technologies Ltd. received the greenlight from the U.S. FDA for the use of its portable dialysis system at home. The clearance brings a much-needed option for patients with end-stage ...

Multiple players are exploring whether modalities designed to combat B cell malignancies can be repurposed against lupus, ...