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The randomized multicenter study will gauge the device’s ability to safely reduce intra- or postoperative cerebrospinal fluid leakage in patients undergoing cranial surgery. Read More
“This case demonstrates the Department of Justice’s commitment to ensuring that medical device manufacturers do not use improper relationships to influence physician decisionmaking and are transparent about the benefits that they provide to physicians,” said Acting U.S. Attorney Jennifer Williams. Read More
The company said that the CE marks cover broad indications for its Fibergraft BG Putty and BG Morsels products for fusion procedures in the lumbar and anterior cervical spine. Read More
After the September 2023 deadline, devicemakers will be required to include a Universal Device Identification (UDI) number on their device labels and packaging. Read More
Eurofins Export Services Oy of Finland has become the 20th notified body designated to certify device products in compliance with the EU Medical Device Regulation (MDR). Read More
A federal judge has issued a preliminary injunction blocking Charles River Laboratories (CRL) from harvesting the blood of horseshoe crabs for use in bacterial contamination tests for drugs and vaccines — a move that could lead to a shortage of the much-needed tests. Read More
The European Commission has proposed stiffer regulations for products that rely on artificial intelligence (AI) and some medical devices would be considered “high risk” under the proposal. Read More
Graphic Controls Data Recording failed to inform the FDA of several complaints about its automatic external defibrillator (AED) pads malfunctioning in a way that could have caused serious injury or death to patients, agency investigators found during an inspection of the company’s Buffalo, N.Y. facility. Read More
Several House Democrats have urged the Department of Health and Human Services (HHS) to reverse a Trump administration policy that removed FDA premarket review requirements for COVID-19 laboratory-developed tests (LDTs). Read More