After first claiming an FDA clearance last year for its mixed reality brain surgery navigation platform, Zeta Surgical has ...

Following the clearance of an investigational new drug application from the FDA, a phase 1 trial will examine the novel ...

The Anovo system. [Image from Momentis] Momentis Surgical (formerly Memic) announced today that the FDA granted 510(k) ...

Corin announced that it received FDA 510(k) clearance for its Icona femoral stem implant for total hip arthroplasty (THA).

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

Clearance for the Phase II oncology trial was achieved following productive feedback sessions with the FDA over the past few months and the submission of a final study protocol to the FDA in September ...

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 ...

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

“This marks the fourth FDA clearance for a QIAstat-Dx test in 2024, and a signal of our commitment to expanding our test menu in the U.S. as well as around the world.” The QIAstat-Dx ...

QIAGEN is expanding its portfolio for QIAstat-Dx in North America, with the recent launch of the QIAstat-Dx Analyzer 2.0, FDA clearance of the Gastrointestinal Panel 2 and submission for FDA clearance ...