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.
EU leaders are deadlocked over a proposed premarket mechanism for the highest-risk devices, and the stalemate threatens to delay adoption of a major overhaul in device and diagnostic regulations until late next year or even 2016. Read More
Manufacturers of passive implants, such as surgical screws, must begin subjecting products to magnetic resonance testing to see if they become dangerous when exposed to MR systems and radiofrequency heating, the FDA says. Read More
Yet another court has ruled against Myriad Genetics in ongoing disputes over the company’s patents on tests to detect genes associated with breast cancer. Read More
Medical imaging maker Volcano was plucked up by Royal Philips for $1.2 billion, just days after Wall Street analysts predicted a rocky year ahead for the San Diego, Calif., devicemaker. Read More
Devicemakers whose products include a drug component could find GMP compliance especially tricky, due to a 2013 regulation that requires expiration dates like those used for drugs, an industry expert says. Read More
Proof that a diagnostic test could be safely performed by untrained workers convinced the FDA to grant a first-ever regulatory waiver for a syphilis rapid screening assay. Read More
New Zealand’s regulatory authority is updating its uniform recall procedure for devices, following a recent decision not to pursue a joint regulatory authority with Australia. Read More
The Indian government appears poised to expand foreign direct investment by medtech companies as it searches for ways to beef up domestic manufacturing. Read More
The FDA last week green-lighted a new test for coronary heart disease, saying it could be especially helpful in detecting the condition in African-American women. Read More
San Antonio, Texas, contract manufacturer Voss Plastics received a 10-citation warning letter for serious lapses in good manufacturing practices and lack of written procedures for adverse event reporting. Read More
An umbrella group in the EU is recommending that health technology assessment bodies pool sensitivity and specificity data from multiple diagnostic accuracy studies using one of two methods: hierarchical summary receiver operator characteristic or bivariate random-effects techniques. Read More
