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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
The FDA is making significant organizational changes to the Center for Devices and Radiological Health (CDRH), which plays a lead role within the agency in how medical devices are evaluated or cleared for clinical investigations and marketing. Read More
“False-positive or false-negative results from improper use of these tests could lead to further exposure of uninfected individuals,” the agency said. Read More