The U.S. Centers for Medicare & Medicaid Services reported a request for information for a modernized digital health ecosystem that would presumably improve beneficiary access to digital health technologies.
Companies new to the world of U.S. FDA regulation are often unaware of how detailed the agency’s inspections are, which might be the case with the October-November 2024 inspection of Noah Medical Inc.
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.
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.
Device makers may find it difficult to avoid running afoul of the Anti-Kickback Statute, but a recent case in the U.S. Court of Appeals for the Seventh Circuit suggests that the statutory definition of a referral is not set in stone.
The U.K. National Institute for Health and Care Excellence (NICE) endorsed the use of the Orbit system by Mindtech Ltd. as a treatment for tics and Tourette syndrome.
The U.S. FDA typically announces its inspections at facilities located outside the U.S. – a courtesy not extended to domestic manufacturing sites. This is about to change per an agency press release quoting commissioner Marty Makary as describing the disparate treatment as a double standard.
The U.S. FDA in 2018 granted the de novo petition by Seattle-based Adaptive Biotechnologies Corp. for the company’s DNA test for evaluation of residual hematological malignancies, but waited until March 8, 2025, to post notice of the attendant regulation.
Legislators in Washington again are considering a pair of bills that would affect how patents are obtained and sustained including the Patent Eligibility Restoration Act of 2025. This would constitute a big win for companies in the life sciences thanks to provisions that clarify just what is and is not eligible for patent protection.
Few observers think of CPAP machines as common fare where the med-tech patent wars are concerned, but Resmed Corp. recently came away with a win in litigation that resulted in the nullification of the first 20 claims of a CPAP patent held by Cleveland Medical Inc.
