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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
A Thursday draft guidance from CDRH attempts to clarify the distinction between hearing aids and personal sound amplification products, or PSAPs. Read More
CDRH plans to roll out 12 final guidance documents in fiscal 2014, including guidances on cybersecurity, the device appeals process and the global unique device identification database, or GUDID, the center revealed Thursday. Read More
San Luis Obispo, Calif.-based FzioMed said the FDA has agreed to hear its appeal on a decision not to approve the company’s Oxiplex Gel spinal product, a clear, absorbable gel applied during lumbar spine surgery. Read More