Prognomiq Inc. secured $34 million in a series D funding round to advance development of an early detection test for lung cancer based on its multiomics platform. The blood-based test could provide an alternative to the underutilized low-dose CT scans currently recommended for individuals at high-risk of lung cancer.

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.

Cell and gene therapy companies are the beneficiaries of positive changes along the regulatory path that the U.S. FDA is paving for them, according to a panel of executives who spoke at the BioFuture 2024 conference in New York. The agency is trying to set up cell and gene companies for success and that’s a very different agency than what it was years ago, said Paul Bresge, CEO of Ray Therapeutics Inc.

Alongside the release of abstracts related to the American Society of Hematology meeting next month in San Diego, and as part of the firm’s third-quarter update, Beam Therapeutics Inc. disclosed that one patient died in the phase I/II trial testing BEAM-101 in sickle cell disease (SCD).

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.