Lex Diagnostics Ltd. has submitted dual applications to the U.S. FDA seeking 510(k) clearance and CLIA waiver status for its Velo system, an ultra-fast point-of-care molecular diagnostics platform. The move comes after the recent news from Quidelortho Corp. that it intends to acquire Lex for $100 million following U.S. regulatory approval of the technology. Read More
With the American Diabetes Association annual meeting a week away, four major diabetes tech companies queued up new partnerships for their devices. Read More
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. Read More
The trade wars spanning the globe lined up some unlikely-seeming adversaries, and such is the case in the trade scrum between the EU and China. Read More
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. Read More
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. Read More
Med-tech firms raising money in public or private financings, including: Atraverse, hellocare.ai, Mayo Clinic, Medx, Stimscience, Somnee, Tagomics. Read More
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. Read More
