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As the 118th Congress continues, FDAnews will be tracking the important pieces of pending legislation to keep you updated on regulations that could impact your business. Read More
Makers of connected medical devices should brace themselves for more FDA enforcement — warning letters, inspections, demands for information and untitled letters — as the digital health space unfolds and evolves, says a former Justice Department prosecutor. Read More
The FDA has deemed Avanos Medical’s Feb. 22 recall of certain Ballard Access closed suction ventilation devices as Class I, the most serious type of recall, as using these devices may cause serious injury or death. Read More
The latest devicemaker to follow an important FDA pathway for technological innovation in devices is French company UroMems, which has snagged a Safer Technologies Program (STeP) designation for its UroActive Smart Continence Therapy device. Read More
Over the past week, the FDA issued a correction of a docket, an authorization and two revocations of diagnostic devices and a request for comments on rapid response surveys. In addition, the agency announced a public workshop. Read More
mRNA developer Moderna and computer giant IBM have announced an agreement under which Moderna will explore next-generation technologies, including quantum computing and artificial intelligence (AI), to accelerate mRNA research and science. Read More
The artificial intelligence device can find caries, root canal defects, bone loss, discrepancy at margin, periapical radiolucency and calculus, the company said. Read More
The FDA has deemed Fresenius Kabi’s March 8 recall of its Ivenix Infusion System as Class I, the most serious type of recall, as use of the device may cause serious injuries or death. Read More
The FDA would like to have the regulatory authority to restrict new opioid approvals to those that are safer than already-approved and marketed opioids, Commissioner Robert Califf told senators at a hearing discussing the agency’s 2024 budget request. Read More