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.

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.

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.

Hifibio Therapeutics Inc. has gained IND clearance from the FDA for HFB-200604, a potentially best-in-class BTLA agonist monoclonal antibody for inflammatory and immunology diseases.

Korro Bio Inc. has announced a submission to the Australian Bellberry Human Research Ethics Committee (HREC) for a phase I/II study of KRRO-110 for α-1 antitrypsin deficiency (AATD).

Disc Medicine Inc. found itself after an end-of-phase II meeting with the U.S. FDA in what Wainwright analyst Douglas Tsao called a “best-case scenario” regarding the path forward for bitopertin in erythropoietic protoporphyria (EPP).

The U.S. FDA reported a class I recall of tracheostomy tube kits by Minneapolis-based Smiths Medical Inc., because of the risk of separation of the tube’s pilot balloon and inflation line.

The U.S. Medicare outpatient final rule affirms several new devices for the new technology pass-through program, but one of the more significant findings is that CMS will use separate payment mechanisms for two renal nerve denervation devices, following the blueprint the agency employed for this question in the inpatient final rule.