FDA clears a Vent Creativity 510(k) for its AI-driven software product, Hermes Knee, for generating surgical plans for mechanical, kinematic, and anat...
Immunovant delays its decision on whether to seek batoclimabs approval for treating myasthenia gravis and chronic inflammatory demyelinating polyneuro...
Former FDAer Henry Miller says uncertainty rules as FDA awaits the expected confirmation of Martin Makary as commissioner.
An FDA medical device early alert says Calyxo has issued updated instructions for using its CVAC Aspiration Systems due to its identification of a new...
FDA says the Baxter 2/5 recall of specific Spectrum infusion pumps was Class 1.
FDA publishes the FY 2025 OTC monograph drug facility fee and contract manufacturing organization fees.
FDA sends Seikagaku a complete response letter on its BLA for condoliase, a treatment that reduces leg pain associated with lumbar disc herniation.
FDA delays its decision on an IceCure Medical de novo marketing authorization request for the ProSense cryoblation device and its use in early-stage l...
