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  • FDA outlines UDI implementation plans for 2015

    The FDA outlined its 2015 plans for Unique Device Identification. If successfully pulled off, the UDI system promises many benefits to companies and consumers, including improved device recalls and better evidence collection.

China eases restrictions on device imports, charting a win for the industry

As med tech companies set their sails toward China, a new trade agreement between the U.S. and Chinese governments looks to ease restrictions for imports, paving the way for greater expansion by U.S. devicemakers.

Sorin says newly cleared Memo 3D ReChord will improve mitral valve repair

Italy's Sorin Group says its just-cleared Memo 3D ReChord semirigid annuloplasty ring for mitral valve repair will simplify the procedure and enable surgeons to achieve reproducible results.

Small cap Cerus spikes on back-to-back Intercept approvals by FDA

Small cap Cerus has gained some serious ground on Wall Street after the FDA approved its Intercept Blood System for platelets just a few days after the agency approved it for plasma use. Investors are betting that with the risk of Ebola in the forefront of public consciousness that processors of blood products will use any technology they can to improve the safety of their supply. These approvals mark the first time the FDA has approved a system to inactivate pathogens in platelets or plasma.

Private equity firm backs Sonoma Orthopedic with $12M to get ankle implant to market

Chicago-based private equity group First Analysis expects its $12 million cash infusion into Sonoma Orthopedic Products will be sufficient for the startup to gain FDA clearance for a new ankle implant--as well as to launch it and start to scale up sales.

Wall Street, media approve of Stryker's multi-year buying spree

In response to Zimmer's $13.4 billion bid for Biomet, rumor has it that Stryker will snatch up the other relatively small orthopedics player, the U.K.'s Smith & Nephew.

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FierceBiotech

AbbVie won an expected FDA approval for its next-generation treatment for hepatitis C, kicking off a race with Gilead Sciences for dominance in a blockbuster field.

FierceDiagnostics

Myriad Genetics won FDA approval for its companion diagnostic test for AstraZeneca's ovarian cancer drug Lynparza, giving the company a boost as it recoups from its latest patent battle loss and helping it gain ground in a fast-growing market.