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BSX wins CE Mark, FDA nod for new S-ICD | Regulatory news for the week of March 23, 2015

March 24, 2015 by MassDevice

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

Boston Scientific wins CE Mark, FDA nod for smaller 'leadless' ICD

March 17, 2015 by Brad Perriello

PAD: Medtronic wins expanded FDA nod for Protégé GPS stent

March 18, 2015 by Brad Perriello

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.

PAD: Medtronic wins expanded FDA nod for Protégé GPS stent

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Varicose vein treatment: VenaSeal wins FDA approval

February 20, 2015 by Brian Johnson

Federal regulators say they have approved the VenaSeal closure system to treat varicose veins

Covidien study: VenaSeal effective in treating leg 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's managed services biz books $1B in sales

February 18, 2015 by Brian Johnson

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's expanding services biz tops $1B in sales

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Medtronic CFO Ellis: Covidien deal frees up 25% more cash

February 17, 2015 by Brad Perriello

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 CFO Ellis: Covidien deal frees up 25% more cash

FLASH: Medtronic's profits jump 30% in Street-beating Q3

February 17, 2015 by Brad Perriello

Medtronic says its fiscal 3rd-quarter profits jumped nearly 30% as it tops Wall Street's forecast, without any contribution from Covidien.

FLASH: Medtronic's Q3 earnings soar 30%