The FDA issued a warning against unnecessary and excessive fetal ultrasound imaging and heartbeat monitoring using Doppler heartbeat monitors, advising women not to receive or perform the procedures at home or for nonmedical reasons.
Monitoring electrocardiograms tracking heart conditions at home may become as cheap, easy and routine as using an electronic thermometer. AliveCor has reduced the price on its ECG monitor to $74.99 from $199; it's also now a third-generation device that is 50% thinner and 40% lighter.
Transformational scientific leaps forward that fulfill fundamental patient needs have fueled the appetite for biotech in recent years. But this year, perhaps for the first time, visions for major med tech leaps forward with the integration of information and wireless technologies seemed to be everywhere. This offers a lot of tantalizing possibilities and readers were eager to explore them.
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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.
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.
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 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.
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.
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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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.
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.