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. Read More
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). Read More
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. Read More
While the inpatient and outpatient final rules for 2025 are baked into the U.S. Medicare payment system, there are indications that Congress will consider legislation that would flatten rates across sites of service. Read More
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. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abbott Labs, Penuma, Penumbra, Shockwave. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Affidea, Aiforia, Bluewind Medical, Complete Genomics, Cvrx, Elucid Bioimaging, Paige. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aitrics, Biotia, Lumithera, Simbiosys. Read More
