We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
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
The FDA is proposing to establish five categories of Class III devices, delineated by risks, benefits and available controls — a move that could help to streamline classification of high-risk devices and promote consistent expectations about the process. Read More
Minneapolis, Minn.-based Greatbatch has issued a field corrective action for its Standard Offset Cup Impactor, after a sterility level of 10-6 was not achieved when the device was subjected to steam sterilization cycles during a recent design and manufacturing transfer, company spokesman Christopher Knospe told Device Daily Bulletin. Read More