Baxter recalls infusion sets over deadly embolism risk

By Damian Garde Baxter ($BAX) has launched a recall of some of its disposable buretrol devices, warning that their valves can allow air to seep into the solution and lead to a dangerous ...

Transcatheter mitral valve-replacement startup pulls in $32.5M

By Mark Hollmer Right now, Edwards Lifesciences ($EW) and Medtronic ($MDT) are the major players in transcatheter aortic valve implantation. But California startup CardiAQ Valve Technologies ...

St. Jude wins injunction in fight with ICD partner

By Damian Garde St. Jude Medical ($STJ) scored a legal victory in its spat with AorTech, which makes the polymer insulation for Durata leads. AorTech has threatened to pull out of ...

GE grabs U-Systems to boost its breast imaging capabilities

By Mark Hollmer GE Healthcare ($GE) snatched up U-Systems this week, less than two months after the California company won a hard-fought PMA approval for its breast cancer ultrasound ...

Pricing pressures, foreign exchange rates dampen Covidien’s Q4

By Mark Hollmer Covidien ($COV) blames foreign exchange rates for causing a sales dip in both its 2012 fourth quarter and fiscal year, but pricing pressures in some device segments ...

Device trade group asks FDA to clarify and change proposed rule on unique device identifiers

By Arundhati Parmar The Food and Drug Administration’s proposed Unique Device Identifier code system is sometimes described as giving the industry a track and trace mechanism ...

E. coli Cases in Northwest Michigan Linked to Unpasteurized Cider

BY NEWS DESK Unpasteurized, unlabeled apple cider is thought to be the source of a series of E. coli infections that have recently cropped up in Antrim County, Michigan. The Health ...

FDA’s Top Supplement Issues

Daniel Fabricant, Ph.D., Director, Division of Dietary Supplement Programs, FDA, gave a quick talk this morning at SupplySide West, touching on FDA’s top regulatory concerns for supplements. ...

Canada’s Supreme Court strips Viagra patent from Pfizer

By David Ljunggren (Reuters) – Canada’s Supreme Court struck down the patent on global pharmaceuticals giant Pfizer Inc’s (PFE.N) Viagra erectile dysfunction drug ...

UK’s NICE rejects Novartis asthma drug in change of tack

(Reuters) – Britain’s health cost-effectiveness watchdog NICE plans to recommend against the use of Novartis’s severe asthma drug Xolair, or omalizumab, after earlier ...

Looming fiscal cliff could be disastrous for state, biotech expo speaker says

By Tom Henderson Be very, very afraid. That was the message delivered Wednesday afternoon at a session at the eighth annual MichBio Expo at theKellogg Hotel and Conference Center on ...

FDA accepts Merck application for insomnia drug

Suvorexant to receive review for controlled substance scheduling BY ALARIC DEARMENT WHITEHOUSE STATION, N.J. — The Food and Drug Administration has accepted an application from Merck ...
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