Here's a look at some of the top regulatory stories for medical device companies this week: Boston Scientific wins CE Mark, FDA nod for smaller 'leadless' ICD; FDA approves Biotronik's Eluna MRI-safe pacemaker; PAD: Medtronic wins expanded FDA nod for Protégé GPS stent; Australian PE shop acquires Simplify Medical
Medtronic says it won a nod from the FDA for its Protégé GPS stent to treat peripheral artery disease in the common and external iliac arteries.
Boston Scientific names former Covidien CFO Charles Dockendorff and Hologic CEO Stephen MacMillan to its board of directors.
Biolase Technology Inc.
, Boston Scientific
, Breg Inc.
, Google Inc.
, Hologic Inc.
, Penumbra Inc.
Federal regulators say they have approved the VenaSeal closure system to treat varicose veins
Covidien's VenaSeal closure system to treat varicose veins has been approved by the U.S. Food and Drug Administration, according to an agency press release.
Medtronic CEO Omar Ishrak tells analysts the company's managed services business for cath labs is expanding into new markets, with booked sales topping the $1 billion mark through its fiscal 3rd quarter.
Medtronic CFO Gary Ellis tells analysts that the $50 billion acquisition of Covidien pushes its available free cash flow from 35% to 60%, or about $7 billion annually.
Medtronic says its fiscal 3rd-quarter profits jumped nearly 30% as it tops Wall Street's forecast, without any contribution from Covidien.