
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.
iRhythm Technologies (Nasdaq:IRTC) announced that the FDA granted 510(k) clearance for Zio AT design modifications and labeling updates.
SynCardia announced today that it received a second patent expanding the coverage of its fully implantable artificial heart technology.
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.
Insulet (Nasdaq:PODD) Omnipod 5 users now have a new way to control their automated insulin delivery system.
Novosound today announced the unveiling of an ultrasonic blood pressure monitor, miniaturizing blood pressure monitoring in wearable devices.
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.