FDA clears a Brainomix 510(k) for its Brainomix 360 e-Lung for lung imaging.
FDA grants Notal Vision a de novo authorization for its patient self-operated SCANLY Home optical coherence tomography device.
Federal Register notice: FDA announces the issuance of emergency use authorizations (EUAs) for certain medical devices related to Covid-19.
FDA publishes 32 new and revised product-specific guidances to aid in development of generic drugs and a revised list of PSGs under development.
FDA grants Karius a breakthrough device designation for its Karius Test for use in the diagnosis and management of immunocompromised patients with sus...
The Humane Society of the U.S. petitions FDA to take actions to inform drug developers and sponsors that they are not always required to perform anima...
The Alliance for a Stronger FDA urges Congress to provide FDA with $3.9 billion in budget authority for fiscal year 2025, which is more than $200 mill...
Federal Register notice: FDA announces the issuance of a priority review voucher to X4 Pharmaceuticals in response to gaining approval of a rare pedia...
