FDA clears an AI Optics 510(k) for its Sentinel Camera, a handheld retinal imaging device for capturing images of the human eye.
TerSera petitions FDA to require any ANDA referencing Prialt to conduct compatibility testing with the Medtronic pump that is specified in Prialts lab...
Robert F. Kennedy Jr.s cousin, Caroline Kennedy, sends a scathing letter about his background to U.S. senators on the eve of a confirmation hearing to...
FDA approves a new indication for Novo Nordisks Ozempic to reduce the risk of worsening kidney disease and cardiovascular death in adults with Type 2 ...
FDA grants Beckman Coulter Diagnostics a breakthrough device designation for its Access p‑Tau217/β-Amyloid 1-42 plasma ratio assay to help ...
FDA clears an Imperative Care 510(k) for its Zoom System, a stroke thrombectomy system with .088-inch catheters.
FDA approves a Supernus Pharmaceuticals label update for attention-deficit/hyperactivity disorder drug Qelbree (viloxazine extended-release capsules) ...
Provepharm recalls one lot of phenylephrine hydrochloride injection, USP, 10 mg/mL due to a customer complaint about visible black particulate matter ...
