Post-Covidien Shopping Spree: Medtronic makes a $150M play for embolization device firm
Medtronic (Dublin) appears to be making good on its promise to invest in and acquire U.S. medical technology following its $42.9 billion purchase of Covidien. The company just acquired Medina Medical (Menlo Park, Calif.), a private firm it already had an ownership stake in, for $150 million plus milestone-based payments.
Continuous monitoring; The Medicare CGM coverage fight
Continuous glucose monitors have been around for a few years, but the Centers for Medicare & Medicaid Services has had little to say about them to date. NHIC, a Medicare administrative contractor that seems to serve as the agency's point for durable medical equipment, has declared that CGMs are not coverable, and the coverage debate is getting noisier every day.
Reversal in regulatory pathway? Europe's changes to CE mark suddenly make FDA-first approval seem attractive
PARIS Later this year, the European Union is almost certain to impose a pre-market authorization procedure for novel high-risk implantable medical devices (Medical Device Daily, July 7 and July 8, 2015).