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FDA Wary of Mobile Urine Tester, Clears iPhone 5-Compatible Devices
Biosense Technologies (India) has developed a mobile urine lab known as uChek that was accepted into Apple’s App Store. The product, however, was not submitted to FDA for regulatory clearance, and the agency has issued a letter to the company urging them to do so. This marks the first time that the agency has issued such a warning to a maker of mobile-enabled health-monitoring product. The app tests for 25 medical conditions ranging from diabetes to urinary tract infections.
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Cook Medical's Zilver PTX Receives Class I Recall Status
Following reports that Cook Medical's Zilver PTX drug-eluting stent could separate from delivery catheters during implantation, the device received Class I recall status from the FDA. The company recalled the device in April due to an issue with its delivery catheter. Under some conditions, the delivery catheter could put a patient at an increased risk of amputation, thrombosis or death.
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Cardiologists Lambast FDA for Dangerously Slow Device Approvals
Through the European Union’s CE Mark certification program, cardiologists in the European Economic Area have access to cutting-edge technologies. This includes TAVR devices like the Sapien XT by Edwards Lifesciences and CoreValve by Medtronic, which have been commercialized years in advance before their debut in the United States. However, cardiologists in the United States face increasing frustration as they wait for FDA regulators to approve next-generation products.
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Tryton Medical Aims for FDA Approval for Side Branch Stent
At EuroPCR, Tryton Medical (Newton, MA) announced its new initiative to win favor with FDA regulators. As of now. the Tryton Side Branch Stent has approval in the Middle East, Russia and Europe. However, FDA approval has eluded the implant so far. Under the leadership of the Nordic-Baltic Bifurcation Study Group, a new 150-patient trial may help get the stent gain entry into the U.S. market.
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Drug-Coated Balloon Shows Promise in Covidien's First-in-Human Clinical Study
Covidien (Mansfield, MA) recently released positive results for its new first-in-human drug-coated balloon as the European Association of Percutaneous Cardiovascular Interventions (EAPCI) Congress in Paris wraps up.
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Intuitive Surgical Wins First da Vinci Patient Injury Lawsuit, 25 Plus Cases Pending
While Intuitive Surgical (Sunnyvale, CA) faces dozens of patient injury lawsuits related to its da Vinci robotic surgery system, its first patient injury lawsuit has ended in victory for the company, according to Bloomberg. In the 10–2 verdict, a Washington jury decided that the company did not demonstrate negligence in its robotic surgery training program.
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Toshiba and Others Battle for Stake in Panasonic’s Healthcare Division
With Panasonic selling a stake in its healthcare division, several major industry players are vying for a piece of the ailing electronics manufacturer. While early rumors indicated that Panasonic would sell its entire healthcare division, the company will retain partial ownership of its medical device group. The overall group could be worth as much as $1 billion.
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BPA Levels in Medical-Grade Polycarbonate Not Risky, Ethicon Study Shows
Bisphenol A (BPA) has has been linked by health experts to of health problems including cancer and reproductive toxicity. In fact, last month, the state of California added the compound to a list of chemicals known to cause reproductive problems under Proposition 65. In 2009, the compound came under the scrutiny of FDA.
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Medtronic Receives First CE Mark for Valve-in-Valve Procedures
Medtronic has announced that the CE Mark would cover valve-in-valve procedures that use the company’s CoreValve Evolut and CoreValve transcatheter aortic valve implantation systems in patients suffering from degenerated bioprosthesis surgical aortic valves. This represents the first CE Mark approval for valve-in-valve procedures.
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Stentys Cardiac Stent Reduces Heart Attack Rate One Year After Implantation
Stentys (Paris, France) has announced positive results from its Apposition III trial. The primary endpoint of the study was the incidence of major adverse cardiac events (MACE) at 12 months. For the patient population in the study, the MACE percentage was 9.3%. The MACE rate for conventional stents averages 11.1%.
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