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Despite few safety risks, a sharply divided FDA advisory panel voted not to reclassify cranial electrotherapy stimulation (CES) devices from Class III to Class II because of a lack of data to support the products’ efficacy.
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Getting supplier quality under control is crucial if devicemakers wish to avoid the risk of product liability and its accompanying financial hit, industry experts say.
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Last year, the federal government collected $1.45 billion in settlement from pharmaceutical and medical device companies, and the most common charge of alleged misconduct was off-label promotion, according to law firm Skadden.
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Johnson & Johnson has offered unnamed concessions meant to ease the European Commission’s antitrust concerns over the company’s proposed $21.3 billion acquisition of leading orthopedic device maker Synthes.
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Boston Scientific’s ION Paclitaxel-Eluting Platinum Chromium Coronary Stent system and TAXUS Liberte Paclitaxel-Eluting Coronary Stent system have received U.S. Food and Drug Administration approval for use in patients experiencing an acute myocardial infarction, or heart attack.
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Medication via remote-control instead of a shot? Scientists implanted microchips in seven women that did just that, oozing out the right dose of a bone-strengthening drug once a day without them even noticing.
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Applications are now open for ZeroTo510, a program designed to help entrepreneurs bring medical device products and companies to market, and are being accepted now through April 5.
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