FDA clears a Philips 510(k) for its new Spectral CT Verida system, which the company describes as the first AI-powered detector-based spectral CT scan...
FDA satellite laboratories branch director JaCinta Batson touts the value of the laboratories work in international mail facilities to stop illegal an...
FDA classifies a correction involving certain ventilators manufactured by Philips as a Class I recall, warning that continued use of the devices witho...
FDA seeks expansion of testosterone replacement therapy use, encouraging drugmakers to explore whether existing products could be approved to treat lo...
An Institute for Clinical and Economic Review white paper states the potential benefits and challenges of several policy changes that could strengthen...
AdvaMed says it supports FDA efforts to expand exemptions from premarket notification for some Class 2 devices.
The Trump administration nominates former deputy surgeon general Erica Schwartz to be CDC director, and taps FDA principal deputy commissioner Sara Br...
Eli Lilly says it will seek expanded FDA approval by the end of the quarter for its obesity drug Foundayo (orforglipron) as a treatment for diabetes, ...
