London-based Livanova plc. has petitioned the U.S. CMS to cover vagus nerve stimulation device for treatment-resistant depression without the need for a clinical trial — a change that would eliminate the costly and cumbersome coverage with evidence development mechanism.
The med-tech industry brought in $13.74 billion from January through May 2025, up from $12.76 billion during the same period last year. In May alone, the sector raised $3.51 billion across 47 transactions, nearly doubling April’s total value of $1.88 billion from 37 deals.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alamar Biosciences, Artera, Boehringer Ingelheim, EBR Systems, Echosens, Hellocare.ai, Linear Diagnostics, Mainz Biomed, Paige.AI, Quest.
Despite the June 9 gutting of the U.S. CDC’s Advisory Committee for Immunization Practices, the Department of Health and Human Services said the committee’s June 25-27 meeting will continue as scheduled. But a new panel has yet to be named, and typically ACIP members have a lot of behind-the-scenes work to do before a meeting.
Omada Health Inc. rang the opening bell on the New York Stock Exchange on June 6, marking its first day as a public company, but it won’t be the most recent IPO for very long. Continuing the brisk pace seen so far this year, Caris Life Sciences Inc. is hot on its heels with a road show in progress leading up to its expected debut on the Nasdaq next week.
Newel Health srl received CE mark certification under the European Medical Device Regulation for Amicomed, its digital therapeutic solution for hypertension management. The app, which was cleared as a class IIa medical device, provides clinical insights and behavioral tools to help individuals manage their blood pressure.