Complaints are one of the most commonly cited sections in FDA device warning letters. Read More
Australia’s Therapeutic Goods Administration will transition to the ISO 13485:2016 standard governing medical device quality management systems over the next three years. Read More
In an industry first, the FDA approved an expanded indication for transcatheter heart valves for patients with aortic valve stenosis at intermediate risk for death or complications from open-heart surgery. Read More
Cook Medical announced a global recall of 8,750 units of its Roadrunner UniGlide hydrophilic wire guides due to the possibility of glass particles in the coating of the wire guide units. Read More
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