Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Creo Medical, Soundhealth, Spineup, Volta Medical.
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.
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.