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Boston Scientific recalled and issued a safety advisory for some of its implantable cardioverter defibrillators (ICDs) because of accelerated battery depletion, which could shorten the life of the devices.
Japan has the "slowest, least transparent and most difficult regulatory system" of the major medical device markets, hurting developers of innovative, advanced-technology devices, a new report from the International Trade Commission (ITC) says.
Dräger Medical announced it received 510(k) clearance for its Infinity TeleSmart system featuring a compact device that monitors electrocardiogram (ECG) readings and peripheral oxygen saturation.
Medical devicemakers seeking application-specific information on leak testing and functional testing medical products have a new online library of leak test and functional test applications.
A jury found Boston Scientific liable for infringing on Johnson & Johnson's (J&J) Palmaz stent patent in a retrial of patent litigation, Boston Scientific announced.
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has issued a bulletin providing new guidance on reporting and disseminating information about adverse incidents involving medical devices.
A study in the New England Journal of Medicine says computer-aided detection at mammography facilities identifies suspicious findings, "but its effect on the accuracy of interpretation is
unclear."