Less than a week ago, executives at Lyra Therapeutics Inc. were looking ahead to “imminent” data from its first phase III study in chronic rhinosinusitis (CRS), testing drug-device candidate LYR-210, a drug-device candidate largely expected to fill a much-needed gap in CRS treatment. On Monday, May 6, they were announcing plans to preserve cash in the wake of the failed Enlighten 1 study, which raised doubts as to the feasibility of the company’s CRS programs, which also include the similarly designed candidate LYR-220.

Masimo Corp.’s pride and joy, the Stork baby monitor, achieved a new developmental milestone with U.S. FDA clearance for over-the-counter marketing. The agency cleared Stork, which monitors key vital signs including oxygen saturation level, pulse rate and skin temperature, for use on a prescription basis in December. It has been available in the U.S. as a health and wellness device since August 2023.

The U.K. Medicines and Health Care Products Regulatory Agency (MHRA) is among the regulators across the globe that are scrambling to keep pace with artificial intelligence (AI) in medical devices, releasing an April 30, 2024, paper on its own approach. One of the key considerations in this paper is that MHRA expects to up-classify some AI-enabled device software functions in its ongoing regulatory revamp, a prediction that suggests a more stringent premarket path for these products in the years ahead.

The U.K. National Institute for Health and Care Excellence has posted an early value assessment review of digital technologies for the management of chronic obstructive pulmonary disease, giving the conditional nod to only one technology — the Mycopd app by London-based My Mhealth Ltd.

The med-tech industry has seen a surge in financings activities in the first four months of 2024.