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The FDA granted AtheroMed’s Phoenix Atherectomy System 510(k) clearance to treat vessels below the knee in patients with peripheral artery disease. Read More
Stryker is bullish on robotic surgery, planning a first-half 2014 trial of its recently acquired Mako robotic surgery platform for use in full-knee replacements. Read More
The FDA has issued draft guidance standardizing the way companies report computational modeling and simulation studies, paving the way for more computer modeling in medical device trials. Read More
American Aesthetics Medical Supply, a Dallas-based maker of microdermabrasion systems and crystals, lacks appropriate procedures for its suppliers and receipt of incoming ingredients, according to an FDA warning letter. Read More
The FDA does not review new clinical data in considering most cardiac implantable electronic devices, according to a study in last week’s Journal of the American Medical Association — a fact the authors say may have contributed to several high-profile recalls. Read More
Business is on the upswing for St. Jude Medical’s once-beleaguered cardiac rhythm management division, which experienced strong growth in the 2013 fourth quarter. Read More