FDAnews Device Daily Bulletin

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.

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.

Baxter Healthcare is issuing an alert about three problems with its Aquarius hemofiltration machine using software version 6.01.

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.

CardioFocus successfully treated the first patient in a pivotal trial of its HeartLight endoscopic ablation system for atrial fibrillation.

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.

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.

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.

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.