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 Obama administration said it will offer up to $20 million for the development of a rapid diagnostic to identify highly resistant bacterial infections at the point of care. Read More
Jury members in an ongoing bellwether trial over Johnson & Johnson’s Pinnacle hip system will be allowed to consider testimony from an expert who said the company should have known the product was unsafe, a judge ruled recently, landing a blow to the defense. Read More
A high-profile report calling for the elimination of the 510(k) system is misplaced, says Jeffrey Shapiro, director of the law firm Hyman, Phelps & McNamara, who argues what actually is needed is greater transparency. Read More
The Centers for Medicare & Medicaid Services should be more transparent about its plans for the Sept. 30 first release of Physician Payment Sunshine Act data, device and biotech groups say. Read More
Multiple device units manufactured for a single patient usually won’t need to be tallied separately under the FDA’s five-unit limit on custom devices, a new final guidance clarifies.
Read More
Whistleblowers who alleged CDRH read their personal emails cannot proceed with litigation at this time, according to a judge who said plaintiffs must first exhaust all administrative remedies to their claims. Read More
India’s medtech industry could reach $50 billion by 2025 if comprehensive regulatory and reimbursement infrastructures are put in place, a new market research report says. Read More
Devicemaker Brava, a manufacturer of breast enlargement devices, received an FDA warning letter for violating informed consent procedures and conflict-of-interest issues related to clinical trials of its fat micrografting device. Read More
Manufacturers implementing unique device identification may choose a barcode for their Automatic Identification Data Capture technology, or they can use “any other technology that serves the same objectives,” new FDA guidance clarifies. Read More