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.
FDA investigators issued a four-observation Form 483 to Suture Concepts, a manufacturer of soft-tissue management devices, following a December inspection of the company’s Beverly, Mass., facility. Read More
Belgium-based Ion Beam Applications (IBA) has acquired Modus Medical Devices, a Canadian manufacturer of “phantoms” used for quality assurance in radiation therapy. Read More
The FDA has issued a warning about counterfeit COVID-19 test kits that are being marketed in the U.S. — including fake Flowflex COVID-19 test kits and iHealth COVID-19 antigen rapid test kits. Read More
The FDA has clarified that it does not plan to regulate most software apps used in public health — such as the case-counting software programs that have been in use throughout the pandemic — as medical devices. Read More