MedTech News
.................... by Andrew Celentano
SeeMedX Files 510(k) with FDA for Innovative Cardiac Monitoring System to Transform Heart Failure Care
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
FDA clears Quanta home hemodialysis system
Quanta Dialysis Technologies announced today that it received FDA 510(k) clearance for the use of its dialysis system in the home.
R3 Vascular wins FDA IDE for drug-eluting scaffold
R3 Vascular announced today that the FDA granted investigational device exemption (IDE) to evaluate its Magnitude drug-eluting bioresorbable scaffold.
FDA clears second set of changes to iRhythm Zio AT to resolve warning letter
iRhythm Technologies (Nasdaq:IRTC) announced that the FDA granted 510(k) clearance for Zio AT design modifications and labeling updates.
SynCardia picks up patent for total artificial heart
SynCardia announced today that it received a second patent expanding the coverage of its fully implantable artificial heart technology.
FDA clears Exactech porous 3D tibial implant for knee replacement
Exactech announced today that it received FDA 510(k) clearance for its Truliant porous tibial tray, a 3D tibial knee implant.
FDA approves Abbott CGMs for use during medical imaging
Abbott (NYSE:ABT) today announced a significant regulatory milestone that could make common medical procedures easier for people with diabetes.
CytexOrtho gets FDA approval for first-in-human trial of absorbable hip implants
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.