Workflow AI meets breast imaging and structural heart trials: a week of pragmatic progress across funding, CE marks, and sandboxed regulation.
People on the move
Avanzanite Pharma names Giovanni Galliano General Manager for Italy to accelerate rare disease launches and market access.
AVITA Medical Board Chair Cary Vance becomes Interim CEO as company recalibrates commercialization; preliminary Q3 revenue guidance included.
Money flows
Spex Capital (UK) — €30M first commitment toward a €100M Venture HealthTech Fund; targeting early-stage digital health/medtech globally with tickets up to €5M. Expect more UK/EU clinical commercialisation support via its NHS ties.
Gladys (UK) secured £1.5M seed for AI-enabled home care coordination; plans to scale across local authorities and domiciliary providers.
Meta-Flux (Ireland) €1.8M seed (techbio) to expand its AI “virtual biologist” for preclinical decision support; signals steady investor appetite for data platforms feeding medtech/diagnostics pipelines.
On the press
Vara (Germany) granted CE certificate for AI breast-imaging software, enabling EU deployment as an independent second reader and decision-support tool in screening/diagnostics.
MHRA (UK) — selects seven technologies for Phase 2 of the AI Airlock and publishes pilot report; a concrete pathway for AI-as-a-Medical-Device evidence generation in the NHS.
Anteris (USA) — receives first European regulatory clearance in Denmark to commence PARADIGM pivotal trial of the DurAVR transcatheter heart valve; Danish recruitment slated for Q4 2025.
One thing to remember
Even in a choppy macro, European medtech/digital health kept moving: targeted capital (Spex, Gladys), real approvals (Vara CE), and live regulatory pathways (MHRA Airlock) all point to a market rewarding evidence and workflow impact—build for deployment, not demos.
This content has been enhanced with GenAI.
Sources
https://tech.eu/2025/10/13/gladys-secures-1-5m-to-scale-ai-home-care-across-the-uk/
https://www.eu-startups.com/2025/10/british-healthtech-investor-spex-capital-announces-e30-million-commitment-to-e100-million-fund/
https://www.gov.uk/government/news/ai-tools-that-could-detect-diseases-earlier-selected-for-next-phase-of-mhras-ai-airlock-programme
https://www.auntminnieeurope.com/clinical-news/womens-imaging/news/15769386/vara-granted-ce-mark-for-ai-breast-imaging-software
https://www.gov.uk/government/publications/ai-airlock-sandbox-pilot-programme-report
https://www.businesswire.com/news/home/20251013986565/en/Avanzanite-Expands-Italian-Operations-with-General-Manager-Appointment
