MedTech News
LifeSignals Receives FDA 510(k) Approval for UbiqVue™ 2A Multiparameter System
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.
Dr. Martin Makary is Trump’s FDA commissioner nominee
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 picks up FDA nod for remote imaging capabilities
Philips (NYSE:PHG) announced today that it received FDA 510(k) clearance for a number of remote imaging features.
Medtronic nets FDA nod for smart insulin pen app
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 wins CE mark for Invisalign palatal expander
Align Technology (Nasdaq:ALGN) announced today that it received CE mark for its Invisalign palatal expander system.
FDA approves Insightec Exablate Prime for use on Philips systems
Insightec announced today that it received FDA approval and CE mark for its Exablate Prime system with certain Philips MR systems.
Route 92 Medical picks up CE mark for stroke portfolio
Route 92 Medical announced today that it received CE mark for its line of neurovascular intervention products for treating stroke.
CorVent® Medical Receives U.S. FDA 510(k) Clearance for RESPOND® Ventilator
The RESPOND ventilator expands access to care with a 5-year warranty and minimal maintenance needs, enhancing long-term affordability.