Here's a look at some of the top regulatory stories for medical device companies this week.
Australian regulators again warn users of Medtronic's Paradigm insulin pumps of the danger of accidental insulin overdose.
Australian healthcare regulators issued renewed warnings to patients using Medtronic's (NYSE:MDT) Paradigm insulin pumps, cautioning that an accidental button-press may result in a potentially dangerous overdose.
Medtech titan Medtronic plans to seek immediate appeal of a preliminary court injunction banning sales of its CoreValve transcatheter aortic valve implantation system.
Edwards Lifesciences lands a preliminary injunction limiting Medtronic from selling its CoreValve transcatheter aortic valve implantation system in the U.S.
The FDA expands the indication for Medtronic's cardiac rhythm management devices to include bi-ventricular pacing in certain patients.
Medtronic (NYSE:MDT) said the FDA expanded the indication for some of its cardiac rhythm management devices to include bi-ventricular pacing in certain heart failure patients.
U.S. and E.U. cardiologists call for a hard check on global sales of renal denervation technology in the wake of Medtronic's disappointing SYMPLICITY HTN-3 study.
MASSDEVICE ON CALL — A group of cardiologists is taking a hard stance against renal denervation, calling for medical device manufacturers to stop selling the technology as a treatment for hypertension.
Medtronic says it won CE Mark approval in the European Union for its Evera MRI SureScan implantable cardiac defibrillator, claiming it as the world's 1st ICD approved for full-body magnetic resonance imaging scans.
Medtronic (NYSE:MDT) said it won CE Mark approval in the European Union for the world's 1st market-cleared implantable cardiac defibrillator that's safe for full-body magnetic resonance imaging scans, its Evera MRI SureScan ICD.
The Evera device is slated for an immediate launch in Europe, according to a press release.