Medtronic yesterday announced FDA 510(k) clearance of the NC Euphora Noncompliant Balloon Dilatation Catheter to encourage stent apposition to the artery wall.
Treasury Secretary Jacob Lew told the Urban Institute yesterday that "in the very near future" he will decide on steps President Obama can take to curb tax inversion deals without congressional action.
Medtronic said that its recent CE mark for its CoreValve Evolut R System for transcatheter aortic valve implantation paves the way for the option to recapture or reposition artificial valves during heart surgery. The new feature is an advance in the relatively new arena of less-invasive heart surgery for patients who cannot withstand the rigors of open heart procedures.
Pediatric devices are in short supply because of the prevalence of rare diseases in children, as well as their unique physiology. So, FDA's 510(k) clearance of Medtronic's Shillla Growth Guidance System for the treatment of scoliosis in children less than 10 years old has particular significance.
The Medtronic-Covidien integration team must be working overtime juggling not only existing products but also those in the deal pipeline. The pair hasn't slowed down at all--between them they have disclosed 5 acquisitions since their own merger announcement in mid-June, three of them this week alone.
Medtronic wants to be known for manufacturing high-quality devices and providing related services as well. To that end, the company today announced the acquisition of privately held Italian company NGC Medical S.p.A.
Medtronic today announced the $200 million acquisition of the Netherlands' Sapiens Steering Brain Stimulation to bulk up its neuromodulation offerings.
Medtronic snagged FDA approval for its next-generation cardiac resynchronization therapy (CRT) pacemaker in patients with heart failure, expanding its cardiovascular portfolio and advancing its proprietary technology for heart rhythm therapy.
The U.S. Food and Drug Administration has picked up the pace on novel medical device approvals, but this year still may not hit levels seen in 2011 and 2012. During the first six months of 2014, the agency granted 17 premarket approvals, way up from 23 for the entirety of 2013.
Corporate tax inversions, including Medtronic's planned shift to Ireland following its purchase of Covidien, are causing a backlash among some shareholders stuck with a big tax bill becaues of capital gains taxes associated with the deal.