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.
France’s National Agency for Safety of Medicines and Health Products released new cybersecurity recommendations for medical devices designed to minimize the risk of cyber attacks. Read More
Certain models of Medtronic’s MiniMed insulin pumps have potential cybersecurity risks and should be swapped out for newer models, the FDA advised. Read More
The FDA rapped five devicemakers for a variety of violations including complaint handling, validations and failure to establish procedures for process changes. Read More
Most comments on the FDA’s draft guidance for reclassifying surgical staplers supported the move to reclassify devices from Class I to Class II but some cautioned that the rule could adversely affect access to the products. Read More
The FDA issued a June 20 warning letter to Clinicon for quality system lapses related to its SureProble Class II sterile probe following an April 3-4 inspection of the firm’s Oceanside, California facility. Read More
With only nine months to go before the EU’s Medical Device Regulation hits its May 26 application date, the U.S. is pressing the EU to delay implementation for another three years. Read More