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BioWorld - Sunday, April 12, 2026
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Medical technology
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Regulatory actions for June 11, 2025

June 11, 2025
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Creo Medical, Soundhealth, Spineup, Volta Medical.
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LEX Diagnostics VELO system

Lex seeks FDA clearance ahead of $100M Quidelortho takeover

June 10, 2025
By Shani Alexander
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.
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Dexcom G7 CGM

Diabetes partnerships abound ahead of ADA

June 10, 2025
By Annette Boyle
With the American Diabetes Association annual meeting a week away, four major diabetes tech companies queued up new partnerships for their devices.
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Female sitting on floor in dark room

Livanova petitions CMS for VNS therapy coverage reconsideration of TRD

June 10, 2025
By Mark McCarty
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.
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Shipping container with flag of China

European Commission clamps down on Chinese med tech

June 10, 2025
By Mark McCarty
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.
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Green, blue, gray dollar signs

May med-tech financings surged to $3.51B

June 10, 2025
By Amanda Lanier
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.
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Appointments and advancements for June 10, 2025

June 10, 2025
New hires and promotions in the med-tech industry, including: Anteris, Bioporto, Somnum Bene, Enhanced Genomics, Fibrogen.
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Financings for June 10, 2025

June 10, 2025
Med-tech firms raising money in public or private financings, including: Atraverse, hellocare.ai, Mayo Clinic, Medx, Stimscience, Somnee, Tagomics.
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In the clinic for June 10, 2025

June 10, 2025
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Masimo, Viz.ai .
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Other news to note for June 10, 2025

June 10, 2025
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.
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