April may not have brought rain to med-tech, but tariffs and financial uncertainty certainly dampened the enthusiasm for IPOs. With those clouds lifting, three companies – Hinge Health Inc., Capsovision Inc., and Omada Health Inc. – appear ready to flower in May, potentially a harbinger of a return to the brisk pace for med-tech IPOs seen in the opening weeks of 2025 when eight companies raised nearly $1 billion.Read More
Mentaily Ltd. raised $3 million in seed funding for its AI-powered mental health diagnosis, triage and support tool, Liv. The platform is designed to help patients suffering from psychological distress and mental illness. Read More
The U.S. FDA’s April 4, 2025, warning letter to ICU Medical Inc. cited the company for failure to file a new 510(k) for changes to software used in an infusion pump, but those changes may have been driven by problems with the pumps the company acquired when it picked up Smiths Medical in 2022. The FDA also issued a warning letter to Epicare Acquisitions LLC related to its Zenith family of laser hair removal systems. Read More
Noridian Healthcare Solutions opened a draft local coverage determination for gene tests for heritable thoracic aortic disease per a request from Invitae Corp., of San Francisco, which makes a comprehensive panel test for aortopathy. Read More
As the U.S. Department of Health and Human Services (HHS) and its agencies begin weeding out old regulations, the department is requesting public input to help identify and eliminate outdated or unnecessary regulations. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: GE Healthcare, Imperative Care, Raydiant Oximetry, Roche, Seastar. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Apyx, Freespira, GE Healthcare, Know Bio, Prevencio, Rebrain. Read More
