Regulatory & Quality

Velentium supplied the ventilator testing systems that were used in Project V, a collaboration that involved General Motors and Ventec ramping up the U.S. ventilator supply during COVID-19.

FDA said it enacted this measure because there were performance concerns with the accuracy of the test.

The study is set to evaluate POSE 2.0, an incisionless weight loss procedure.

FDA is trying to make it easier to bring COVID-19 testing to the market as a screening tool for asymptomatic people and for sample pooling.

Abbott’s Freestyle Libre 2 iCGM can be used in adults and children over age 4 for a 14-day period. The Abbott Park, IL-based company also released promising data at the American Diabetes Association 80th Scientific Sessions this past weekend.

Earlier this year the fate of Surmodics' SurVeil CE mark submission was unclear as European regulators temporarily halted review of new paclitaxel devices. The tide has apparently turned, however, because the drug-coated balloon is now CE marked.

Chemistry for toxicology (ChemTox) testing has evolved considerably in the last couple years. Here’s what you should consider for your own program.

Medical device companies and their partners have learned a lot about crisis response during the COVID-19 pandemic. Join MD+DI the week of June 22 for several webinars on preparing for future emergencies and preventing potential supply-chain...

ExThera Medical developed the Seraph 100 Blood filter and received Emergency Use Authorization for the technology in April.

The Lexington, MA-based company won an IDE from FDA to launch a pivotal trial of the study. Revita DMR is a same-day, outpatient endoscopic procedure that uses heat to resurface the lining of the upper intestine in a minimally invasive, outpatient...