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Fierce 15

  • Go big or go home: A call for 2015 Fierce 15 nominations

    We need your help to ferret out the best, most timely examples of med tech innovation. Who has ambition and the potential to make a real leap forward, while being wildly appealing to physicians, patients and payers across a global healthcare environment that is increasingly value-based?

FDA warns that Maquet's anesthesia system could lead to a fatal stop in ventilation

On the heels of a permanent injunction from the Department of Justice that resulted in the cease of manufacturing at one of Maquet's facilities, the suspension of 5 of its devices from the market and a $6 million fine, the FDA just warned practitioners that the company's Flow-i Anesthesia Systems have a problem that "may cause anesthesia gas to leak and could prevent the ventilator from providing breathing support if not corrected immediately."

Analysts: Roche sale of diabetes diagnostics unit could be a long time coming

After Bayer offloaded its diabetes device unit last month, some investors thought Roche would follow suit and sell its own underperforming diabetes diagnostics business. The Swiss drugmaker has experienced its fair share of problems with the unit, which stalled recently in light of price cuts and reimbursement issues in the U.S. But anyone expecting a sale of Roche's diabetes diagnostics business shouldn't hold their breath, analysts said.

Novartis launches navigation app for visually disabled on Apple Watch

Novartis launched its ViaOpta navigation app for the visually impaired on the Apple Watch, making it the first app of its kind to run on a smartwatch. It's also available on Android Wear.

FDA approves a second placement confirmation test for Bayer's controversial Essure birth control device

It may be too little too late. But now the FDA has signed off on the use of transvaginal ultrasound as a means of ensuring the proper placement of the Essure permanent birth control device within three months of its insertion.

GlySure gets CE mark for first continuous intravascular glucose monitor for hospital use

Managing blood glucose levels tightly helps improve morbidity and mortality rates among diabetics. That's particularly true for diabetics who have other major health problems. Now British startup GlySure has gained a CE mark specifically for use in intensive care units with adult cardiac surgery patients. Until now, blood glucose management for these critically ill patients often required frequent manual monitoring by the hospital staff.

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