FDA clears an Empatica 510(k) for its Embrace, a pediatric epilepsy smartband that detects patterns in motion and physiological signals that may be as...
Seven former FDA commissioners call for sweeping changes to transform FDA into an independent federal agency that is not part of HHS.
As FDA enters the third week of the partial government shutdown, agency employees still on the job face increasing challenges with fulfilling public h...
FDA approves a MicroVention (a Terumo subsidiary) PMA for the WEB Aneurysm Embolization System for treating intracranial wide neck bifurcation aneurys...
U.S. Supreme Court justices appear to be leaning in Mercks favor in its pursuit to reverse a 3rd Circuit Court of Appeals ruling that allowed hundreds...
FDA clears a Neocis 510(k) for additional dental materials to be used with Yomi, the companys robot-assisted dental surgery system.
FDA issues a new Software Precertification (Pre-Cert) Pilot Program working model 1.0, Test plan, and regulatory framework to explain how it envisions...
Lupin Pharmaceuticals recalls 42 lots of ceftriaxone for injection in varying product strengths because they have been found to contain visual grey pa...