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Johnson and Johnson said Monday that it accepted an offer from The Carlyle Group, extended in January, to acquire Raritan, N.J.-based Ortho-Clinical Diagnostics. Read More
The FDA has warned Ultradent, a dental device manufacturer, for significant and repeated quality violations related to CAPAs, packaging, labeling and device design. Read More
The U.S. could save about $30 billion in healthcare costs a year by requiring medical devices to be interoperable, a white paper by West Health Institute and the Office of the National Coordinator for Health IT concludes. Read More
CDRH will now publish a Federal Register notice and post “Immediately in Effect” guidance on its website when it changes its scientific expectations for a product under development, according to a final standard operating procedure that took effect Wednesday. Read More
Sponsors of 510(k)s for electrosurgical devices and bipolar electrosurgical vessel sealers intended for general surgery should test the biocompatibility of all materials that will come into contact with the patient, a pair of FDA guidances recommend. Read More
The FDA has approved St. Jude Medical’s Allure Quadra Cardiac Resynchronization Therapy Pacemaker (CRT-P), Assurity pacemaker and Endurity pacemaker families of devices. Read More
The FDA’s Molecular and Clinical Genomics Devices Panel voted yes, and yes again, to recommend approval of two new colon cancer diagnostics, paving the way for a new generation of less-invasive tests to screen for the disease. Read More
A new UK proposal would allow the country’s healthcare administration to consider “burden of illness” as a measurable component when assessing new medical products for government reimbursement. Read More