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.
Covidien and Medtronic announced more than 45 people will join a newly created team to tackle integration issues during their merger.
Medtronic has tied its long-term growth to three pillars: strong U.S. sales, double-digit growth in emerging markets and Covidien. But last quarter, the medical device giant didn't deliver on emerging market revenue growth as it encountered difficulties with distributors in India and China. It expects to return to double-digit gains in both countries this fiscal year.
Speculation is building that Minneapolis-based Medtronic will modify its offer for Dublin-based Covidien.