The FDA announced a class I recall of Evair compressors by Chicago-based GE Healthcare due to elevated levels of formaldehyde when the devices are used with specific models of Carescape or Engstron ventilators.
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) set up its second overseas regulatory office in Washington, four months after the drug and med-tech regulator opened its first Asia base in Bangkok, Thailand, in July 2024.
Qiagen NV added to its growing roster of panels cleared by the U.S. FDA in 2024 with the agency’s nod for its Qiastat-Dx Meningitis/Encephalitis assay. The clearance validates Qiagen’s strategy of developing rapid tests specifically for the U.S. market and builds on the respiratory, gastrointestinal and central nervous system tests already available.
The U.K. government is partnering with Oxford Nanopore Technologies plc to use its sequencing technology to create the world’s-first ‘early warning system’ for future pandemics. The partnership includes the development of a pathogen-agnostic biosurveillance system across the national health service (NHS).
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aitrics, Biotia, Lumithera, Simbiosys.
Medicare coverage of digital mental health therapies has traditionally been lacking, but the final Medicare physician fee schedule for 2025 added three new codes to deal with the coverage gap.
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