LAS VEGAS, Nov. 4, 2024 /PRNewswire/ — SeeMedX Inc. (“SeeMedX”) today announced the submission of its 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for its innovative, non-invasive cardiac monitoring device, designed to allow medical professionals to have real-time insights into cardiac performance and fluid status
Quanta Dialysis Technologies announced today that it received FDA 510(k) clearance for the use of its dialysis system in the home.
R3 Vascular announced today that the FDA granted investigational device exemption (IDE) to evaluate its Magnitude drug-eluting bioresorbable scaffold.
iRhythm Technologies (Nasdaq:IRTC) announced that the FDA granted 510(k) clearance for Zio AT design modifications and labeling updates.
Exactech announced today that it received FDA 510(k) clearance for its Truliant porous tibial tray, a 3D tibial knee implant.
Abbott (NYSE:ABT) today announced a significant regulatory milestone that could make common medical procedures easier for people with diabetes.
CytexOrtho today said it has approval from the FDA to start a Phase 1 clinical trial evaluating the safety and efficacy of its absorbable hip implant in human patients.
Paragonix Technologies this week announced it received FDA 510(k) clearance for its KidneyVault donor kidney preservation system.
Distalmotion announced today that it received FDA de novo approval for its Dexter surgical robot for adult inguinal hernia repair.
Vantis Vascular announced today that it received FDA 510(k) clearance for its CrossFast integrated microcatheter guide extension system.