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If sequestration cuts continue into the 2014 fiscal year, CDRH will not be able to hire the review staff the agency promised to hire under MDUFA III, Director Jeffrey Shuren told Congress Friday. Read More
A federal court in California has ruled that using conventional diagnostic techniques in concert with a natural phenomenon does not add enough to make the end product patent-eligible. Read More
Seattle-based Atossa Genetics has initiated a Class I recall of all lots of its Mammary Aspiration Specimen Cytology Test (MASCT) and the accompanying patient sample kit, along with the ForeCYTE Breast Health Test Kit, manufactured between Jan. 9 and Sept. 13, 2013. Read More
A group of patient advocacy organizations is urging Congress to pull back on proposed cuts in Medicare coverage for medical imaging, saying further reductions will seriously impede access to life-saving screening and radiation therapy services. Read More
Smith & Nephew announced the U.S. launch of its Healicoil Regenesorb suture anchor at the Arthroscopy Association of North America Fall Course in Las Vegas. Read More
OrthoSensor and Zimmer Holdings have signed a collaborative marketing agreement pairing Zimmer’s NexGen brand of knee replacement systems with OrthoSensor’s Verasense technology in the U.S. and abroad. Read More
CardioInsight, an Ohio-based devicemaker specializing in mapping abnormal heart rhythms, has secured $15 million in long-term strategic financing for its noninvasive ECVUE monitoring system. Read More
Better communication between CDRH and the Center for Drug Evaluation and Research should translate to fewer requests for duplicate data on companion diagnostic submissions. Read More
Infusion medication errors and alarm fatigue remain the leading health technology hazards for the coming year, a new report by the ECRI Institute says. Read More
Unilife shareholder Byron Brandt has filed a federal securities class-action suit against the devicemaker for alleged false statements about financial performance and quality compliance. Read More
Aptalis, a specification developer for the Flutter mucus clearance device, failed to report a contract manufacturer’s rework of devices to correct issues both this year and in 2012, a recent FDA warning letter says. Read More