SEOUL, South Korea, Nov. 25, 2024 /PRNewswire/ — Neurophet, an artificial intelligence (AI) solution company for brain disease, announced on the 25th that its brain MRI analysis software “Neurophet AQUA”, has obtained 510(k) clearance from U.S. Food and Drug Administration (FDA) for its newly integrated multiple sclerosis (MS) analysis functionality.
MILPITAS, Calif., Nov. 25, 2024 /PRNewswire/ — LifeSignals, Inc. today announced that the UbiqVue 2A Multiparameter System has received FDA Class II 510(k) clearance, marking a significant milestone in continuous wireless patient monitoring for population health management.
President-elect Donald Trump has nominated Johns Hopkins University surgeon Dr. Martin Makary to be the next commissioner of the FDA, according to media reports.
Philips (NYSE:PHG) announced today that it received FDA 510(k) clearance for a number of remote imaging features.
The clearance paves the way for the launch of Medtronic’s Smart MDI system, which combines its InPen and Simplera continuous glucose monitor for people who take multiple daily insulin injections.
Align Technology (Nasdaq:ALGN) announced today that it received CE mark for its Invisalign palatal expander system.
Insightec announced today that it received FDA approval and CE mark for its Exablate Prime system with certain Philips MR systems.
Route 92 Medical announced today that it received CE mark for its line of neurovascular intervention products for treating stroke.
The RESPOND ventilator expands access to care with a 5-year warranty and minimal maintenance needs, enhancing long-term affordability.
President-elect Donald Trump today said he is nominating Dr. Mehmet Oz to serve as administrator of the Centers for Medicare & Medicaid Services (CMS).