This week: primary-care “rollup + AI” gets real money, non-invasive metabolic wearables keep attracting believers, and Brussels finally brought out the MDR/IVDR wrench set. It is silent for the end year festive break. Note, that also our weekly brief will stop until 9th of January.
Festive Break Notice
This will be the last Weekly Brief of 2025. We’re taking a short festive pause and will return with the next edition on January 9th. If Brussels sneaks out any last-minute surprises, we’ll catch them in the first January roundup.
A big thank-you to all the founders, operators, investors, clinicians, regulators, and quietly heroic compliance teams pushing European medtech and digital health forward.
Wishing you a restful break, clearer pipelines, faster CE paths, and fewer “please clarify” emails in 2026. Here’s to another year of building, fixing, and occasionally disrupting healthcare across Europe.
See you in January.
People on the move
European Innovation Council (EIC) — The Commission appointed the new EIC Board, which steers one of Europe’s biggest deeptech funding engines (relevant for medtech spinouts and scale-ups hunting EIC Accelerator/EIC Fund routes).
Money flows
Jutro Medical (Poland) €24M Series A extension (bringing Series A to €36M); scaling an AI-enabled primary care operator model (own clinics + own EHR + AI agents for admin).
Liom (Switzerland) €13.9M (CHF 13M) Series A extension (Series A now CHF 38M, total funding CHF 63M) to push its non-invasive glucose-monitoring wearable platform toward a miniaturised form factor.
Lucis (France) €7.2M ($8.5M) Seed led by General Catalyst (with YC and others) to expand preventive health testing and its biomarker dashboard across European markets.
Smile Genius (Ireland) €850k raised to date, with fresh backing cited from Enterprise Ireland, Haatch (UK) and angels; building dental clinic–lab workflow software and expanding across UK/Ireland.
On the press
EU MDR/IVDR reform (finally, a real proposal).
The Commission published a proposal to simplify and reduce burden in MDR/IVDR (including digitalisation and targeted changes), kicking off the next legislative phase with Parliament/Council.
EU digital health market access, still fragmented
France Digitale launched a petition calling for a unified EU framework to evaluate digital innovation, drawing on work coordinated by EIT Health’s task force on digital medical devices.
CE registration: point-of-care biopsy support tool enters EU market
CellTivity Scientific says its Van Gogh™ Microscopy System received CE registration (Class A under IVDR, per the release), enabling clinical use and commercial distribution across the EU.
One thing to remember
Capital is still flowing to “close-the-loop” models (care delivery + workflow software + automation) and to ambitious sensing platforms, but the biggest medium-term lever might be regulatory plumbing: if the MDR/IVDR simplification proposal holds together, 2026 could be the year Europe makes compliance timelines feel less like a hostage situation.
