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Digital Health MedTech

Europe MedTech & Digital Health Weekly Brief (Week of Sep 28–Oct 4, 2025, #7)

A brisk week: AI health coaching nets fresh capital, vet workflow AI gets a push, CE-marked remote monitoring scales, and Brussels opens the door for MDR/IVDR feedback.

People on the move

Dentsply Sirona: Aldo M. Denti appointed EVP & Chief Commercial Officer effective Oct 6 to align global business units with commercial execution. Mr. Denti brings extensive experience from J&J MedTech, especially DePuy (orthopaedics) and Acuvue (Vision Care).

Money flows

Simple Life (UK): €29.8M Series B, AI health coach; led by HartBeat Ventures. Plan: expand AI personalisation, gamification; claims strong revenue and active subs.

Lupa (UK): €17M Series A, AI-native operating system for veterinary clinics; launching a Veterinary AI Lab and scaling across Europe.

RDS (FR): €14M Series A to industrialise and expand MultiSense RDS, a CE-marked connected patch for continuous remote patient monitoring across Europe.

SeaBeLife (FR): €2M pre-Series A to advance dry AMD and severe acute hepatitis programs (biotech angle with medtech-adjacent implications for retina diagnostics ecosystems).

On the press

• European Commission launches a “Call for Evidence” on the future of MDR/IVDR (targeted revision to reduce burden, improve predictability, enable digitalisation). Deadline: Oct 6, 2025.
• HERA invites applications. Joint Industrial Cooperation Forum call is live; applications due by Oct 29, 2025 (17:00 CEST).
• Cardiology device rollout: Elixir Medical begins full European rollout of LithiX high-capacity IVL following CE mark; >400 patients treated across 16 countries.
• Swiss TAVI protection play advances in US. FDA clears pivotal trial for AorticLab’s FLOWer embolic protection system (already CE-marked in EU since 2024), signalling a scale-up trajectory for a Europe-born device.

One thing to remember

Regulation and reimbursement tailwinds matter: with Brussels actively revisiting MDR/IVDR and CE-marked RPM/IVL tools scaling across hospitals, founders who align early with compliance workflows and real clinical endpoints will move faster on procurement and pilots than those chasing generic “AI copilot” stories.

By Piotr Wrzosinski

Piotr Wrzosinski is a Pharma and MedTech commercialization and digital marketing expert with 20+ years of experience across pharma (Roche, J&J), consulting (Accenture, IQVIA) and medical devices (BD).
He leads transformative EMEA Omnichannel Delivery Center team at Becton Dickinson and shares insights on Pharma, MedTech and Digital Health at disrupting.healthcare to speed up digital innovation in healthcare, because patients are waiting for it.

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