Clinical-trial AI cash, senior care safety tech, and a trio of MDR certifications: Europe’s week mixed capital, commercialization, and infrastructure-level digital transformation.
People on the move
Guerbet Karim Boussebaa appointed CEO, effective Feb 2, to sharpen execution in imaging contrast and interventional solutions as the firm targets high-growth AI integration.
Medicines for EuropeSteffen Saltofte (CEO of Zentiva) officially begins his tenure as President for the 2026–2028 term, focusing on “open strategic autonomy” and manufacturing resilience.
Money flows
Biorce $52.5M (approx. €48.6M), Series A, AI platform for clinical-trial design; the largest Iberian healthtech Series A to date, led by DST Global Partners to eliminate costly protocol amendments.
Gardia €8.5M, Series A, mobile senior safety tech; the German startup is scaling its smartphone-free fall-detection wristband across the DACH region with insurance reimbursement.
Hublo €40M, reinvestment vehicle; following a 2025 exit, Revaia is doubling down on the Paris-based workforce management leader to support post-exit growth under new majority ownership.
Ahead Health $6M (approx. €5.5M), Seed, AI-native preventive health; the Zurich-based firm is deploying its “personal health OS” through partnerships with clinics in Switzerland and Germany.
NuVision Biotherapies £4.8M (approx. €5.7M), scale-up round; Nottingham-based spinout expansion of its amniotic membrane products for ocular wound healing into 12 new countries.
Linda AI €2.6M, Pre-seed; dental front-desk voice-AI automation expanding into the UK and Ireland markets to address clinical staffing bottlenecks.
On the press
Government of Ireland National EHR Procurement The Minister for Health approved the commencement of vendor shortlisting for a single, integrated digital record for every patien, the largest digital project in Irish state history.
MDR Win: P&F Products and Features The Vienna-based firm received EU MDR certification for its TricValve® Transcatheter Bicaval Valves, a Class III solution for severe tricuspid regurgitation.
MDR Win: Acarix Secured EU MDR certification for the CADScor System, its non-invasive AI-acoustics tool for ruling out significant coronary artery disease at the point of care.
MDR Win: Biocomposites Gained MDR certification for STIMULAN Rapid Cure, the first calcium matrix carrier to be certified for use with combined antibiotics in bone and soft tissue.
Ecosystem Report Invest Europe and the EIF released an analysis on gender and geography in VC, highlighting that while capital is consolidating, “American accents” are increasingly driving late-stage European digital health rounds. Download report below:
The “2026 MDR inflection point” is here: four high-stakes certifications in a single week—alongside Ireland’s landmark EHR procurement—signal that the market is ruthlessly pivoting away from “pilotitis” toward infrastructure-level integration and hard regulatory validation.
For years, European imaging AI founders have been trapped by Rule 11 of the MDR, which effectively pushed almost all diagnostic software into Class IIa or higher. However, the regulatory landscape shifted dramatically this week as the European Commission’s simplification proposal moved toward implementation, signaling a fundamental win for the digital health sector.
Full Text of Rule 11
Software intended to provide information which is used to take decisions with diagnosis or therapeutic purposes is classified as class IIa, except if such decisions have an impact that may cause: – death or an irreversible deterioration of a person’s state of health, in which case it is in class III; or – a serious deterioration of a person’s state of health or a surgical intervention, in which case it is classified as class IIb. Software intended to monitor physiological processes is classified as class IIa, except if it is intended for monitoring of vital physiological parameters, where the nature of variations of those parameters is such that it could result in immediate danger to the patient, in which case it is classified as class IIb.
All other software is classified as class I. [Source]
1. The End of the “IIa-by-Default” Nightmare
The core of the recent reform (Obelis (Jan 28, 2026)) addresses the “classification nightmare,” in which even low-risk software was subjected to the same scrutiny as invasive devices.
The Change: Software used for monitoring, prediction, or diagnosis that does not carry a risk of death or serious deterioration may now be eligible for Class I.
Impact: This allows for self-certification in many triage and screening applications, slashing time-to-market from 18 months to weeks and saving startups an average of €150k–€300k in initial audit fees.
2. Perpetual Certificates for Adaptive AI
Traditional MedTech regulation was built for hardware that doesn’t change. Software, particularly Adaptive AI, requires constant iteration.
The proposal to replace the fixed 5-year certificate validity with a risk-based, continuous surveillance model means that software updates will no longer be held back by fear of triggering a full re-certification cycle.
3. The “Fast Lane”: Breakthrough Device Status (MDCG 2025-9)
Recent guidance (Johner Institute (Jan 21, 2026)) and analysis this week highlight the power of the Breakthrough Device (BtX) designation.
For imaging AI targeting life-threatening conditions (e.g., automated stroke detection or rare oncology), this status offers:
Priority Review: Notified Bodies are now encouraged to prioritize these files.
Scientific Advice: Direct access to EU Expert Panels to validate clinical evidence strategies before full submission.
4. AI Act vs. MDR: Clearer Boundaries
A critical clarification emerged this week (Osborne Clarke (Jan 28, 2026)): AI-based medical devices will likely be treated as lex specialis. High-risk AI requirements from the AI Act will be integrated into the MDR/IVDR process, ensuring that imaging companies face a single conformity assessment rather than duplicative audits.
Checklist: Is Your AI Ready for the “Breakthrough” Path?
Use this 5-point assessment based on the new MDCG 2025-9 framework:
Criticality: Does your tool address a life-threatening or irreversibly debilitating condition?
Innovation: Can you prove a high degree of technological novelty compared to the current “state of the art”?
Clinical Impact: Is there a reasonable expectation of significant improvement in patient outcomes (e.g., faster time to treatment)?
Evidence Lifecycle: Do you have a robust plan for Post-Market Clinical Follow-up (PMCF) to manage residual uncertainty?
Regulatory Maturity: Is your Quality Management System (QMS) ready for the intense “structured dialogue” with Notified Bodies required for BtX status?
The European ecosystem is trading complexity for clarity this week: a landmark proposal to “de-clog” the MDR/IVDR bottleneck arrives alongside major CE marks in diabetes, while surgical imaging and pharmacy infrastructure secure fresh growth capital to scale.
The French-American exoskeleton pioneer, famous for its self-balancing “Eve” system, has appointed the CEO of Permobil to its board. This move signals a hard pivot from R&D to global commercialization in the assistive mobility sector.
The Swiss growth-stage investor has added two Growth Partners to strengthen its health-tech and fintech crossover plays, focusing on digital infrastructure in the DACH region.
Money flows
SamanTree Medical €20M (Venture Debt/EIB), Surgical Imaging; The European Investment Bank (EIB) is backing the Lausanne-based startup to scale its Histolog® Scanner. The device offers real-time, ultra-high-resolution imaging of tissue margins during surgery, aimed at reducing cancer re-operation rates.
Evaro €23.1M ($25M), Series A, Digital Health Infrastructure; Led by AlbionVC, the London-based startup provides “healthcare-as-a-service” API infrastructure. The capital will expand its NHS-licensed digital prescribing services for partners like Clue and Lovehoney.
Essity €400M (EIB Loan), Hygiene & Wound Care; The Swedish giant secured a massive RDI injection to advance bio-based materials and digital wound care solutions across its hubs in Sweden, Germany, and France through 2028.
MedVasc €2.2M (SEK 24M), Shareholder Round, Vascular; The Swedish startup is using the funds to progress its Solutio™ anesthesia catheter toward FDA approval, targeting a pain-free solution for laser treatment of varicose veins.
On the press
EU Commission / MDR & IVDR Simplification — A transformative legislative proposal has been advanced to reduce administrative burdens. Key highlights include the potential reclassification of certain SaMD (Software as a Medical Device) and the introduction of a perpetual audit model to replace 5-year re-certifications.
Senseonics / Eversense 365 CE Mark — Approval granted for the world’s first one-year implantable CGM. The EU rollout is set to begin in Germany, Italy, Spain, and Sweden, marking a major milestone in long-term diabetes management.
MHRA / Safety & Fee Updates — The UK regulator published its January safety roundup and statutory fee changes for clinical investigations. Crucial for any EU startup with UK deployment on the 2026 roadmap.
One thing to remember
The regulatory “Great Rationalization” has begun: with the EU Commission moving to down-classify medical software and simplify audits, the cost of market entry for SaMD is poised to drop. Founders who can align their clinical evidence with these emerging, leaner pathways will have a massive advantage in the 2026 fundraising environment.
A heavyweight week for the “reimbursement-first” era: chronic care platforms are hitting mega-round scale, NICE is formalizing the digital MSK pathway, and a French-made mitral valve just secured its ticket to the EU market.
People on the move
ONWARD Medical / Ali Kiboro The Dutch-Swiss neurotech leader has appointed Ali Kiboro (ex-AliveDx, Quest Diagnostics) as CFO to steer the commercialization of its spinal cord stimulation systems.
BVI Medical / Jim Hollingshead The former Insulet CEO takes the helm at the ophthalmology specialist as it deploys a $1B financing package to scale its global eye care portfolio.
mOm Incubators / Daniel Green The portable neonatal tech startup named Daniel Green (ex-Caristo, Perspectum) as COO to lead the operational scale-up of its Dyson Award-winning incubators.
Money flows
Oviva €200M ($217M), Series D, AI-enabled Chronic Care; Led by Kinnevik (investing $100M) with participation from Planet First Partners and Norrsken VC. The funding scales its reimbursed digital programs for obesity, hypertension, and T2D across DACH and the UK.
Ananda Impact Ventures €73M, First Close, Health/Deeptech; Backed by the EIF and NRW.BANK, this fifth Core Impact Fund targets later-seed and Series A healthtech startups across Europe.
Cancilico €2.5M, Seed, AI Oncology; The Dresden-based spin-off is building automated hematology diagnostics (MyeloAID) to address the global shortage of pathologists.
On the press
HighLife SAS The Paris-based firm secured CE Mark for its Transcatheter Mitral Valve Replacement (TMVR) system, the first transfemoral, “one-size-fits-most” option for mitral regurgitation in Europe.
NICE Early Value Assessment (EVA) The UK body green-lit 8 digital technologies (including Hinge Health and Joint Academy) for NHS use in managing hip and knee osteoarthritis, provided they undergo 3 years of real-world evidence generation.
Abbott / TactiFlex Duo Won CE Mark for the world’s first dual-energy ablation catheter, allowing physicians to switch between pulsed field (PFA) and radiofrequency (RF) energy during a single AFib procedure.
One thing to remember
Evidence-backed, reimbursed digital care is moving from “pilot” to “platform.” The simultaneous arrival of a €200M round for payer-integrated care (Oviva) and NICE’s formal pathway for MSK apps signals that the “app” era is over, now it is the “clinical utility and evidence”.
Two watchdogs, one playbook. On 14 January 2026, the European Medicines Agency and the U.S. FDA jointly published “Guiding principles of good AI practice in drug development,” a concise set of 10 rules for using AI across the medicines lifecycle, from data collection and model building to post-market monitoring.
It’s not a binding guidance, but it’s the clearest signal yet of how EU and U.S. reviewers want AI-supported evidence generated and governed. EMA news ; FDA page; PDF
What changed (and why it matters)
• Alignment: EMA and FDA are now publicly aligned on AI “good practice.” That reduces ambiguity for EU startups planning global trials and submissions. • Scope: The principles span the full lifecycle, not just model validation. They expect quality data, clear context of use, risk-based methods, human factors, documentation, and ongoing monitoring. • Trajectory: EMA explicitly says this will underpin future, more detailed guidance in Europe—so aligning now is a head start on tomorrow’s rules.
The 10 principles in plain English
The FDA page lists them verbatim; here’s the founder-friendly translation you can map to your technical file.
Human-centric by design → Keep clinicians and patients in the loop; design for usability and safety.
Risk-based approach → Tie effort to risk: higher-risk claims need deeper controls and evidence.
Adherence to standards → Use recognised data, quality, and interoperability standards wherever possible.
Clear context of use → Write a tight intended use and test against exactly that.
Multidisciplinary expertise → Put clinical, statistical, data, and regulatory people at the same table.
Data governance & documentation → Prove data provenance, consent, representativeness, and lineage.
Model design & development practices → Follow good ML engineering: versioning, reproducibility, and guardrails.
Risk-based performance assessment → Validate with clinically relevant metrics, thresholds, and comparators.
Lifecycle management → Define how you will change the model, when you’ll revalidate, and how you’ll communicate changes.
Clear, essential information → Document what matters: assumptions, limitations, and how humans should use the outputs.
What this means for EU medtech/digital health
SaMD and clinical-decision support
Even though the document targets medicines, the expectations rhyme with MDR Annex I (safety/performance), post-market surveillance, and software lifecycle standards (e.g., IEC 62304/82304-1). If your device or DTx relies on AI to generate evidence, reviewers will look for the same hygiene: traceable data, testable claims, human factors, and change control.
Trials with AI in the loop
If you use AI for recruitment, endpoint assessment, imaging reads, or safety signal detection, your protocol should specify the AI’s role, failure modes, human oversight, and re-read plans. That creates audit-ready evidence for both EMA and national CAs/ethics committees.
Global dossiers
Consistency across the Atlantic lowers duplication. You can design one validation program that serves EU HTA and U.S. review, with local adaptations instead of two separate playbooks. FDA page (Jan 14, 2026)
Monday-morning actions
Lock down data lineage • Create a “Data Provenance & Representativeness” appendix: sources, consent terms, inclusion criteria, demographics, and known skews. • Add traceability to your data pipeline (IDs, hashes, timestamps) so you can recreate every training and validation set. Sources: FDA page (Jan 14, 2026)
Nail intended use and claims • Write one-sentence intended use that is measurable. • Define performance metrics and clinically meaningful thresholds tied to that use. Sources: FDA page (Jan 14, 2026)
Predefine change management • Draft an SOP distinguishing minor vs. major model changes, required revalidation, and notification/communication steps. • Add versioning and a Model Bill of Materials (MBOM): training data versions, model hash, code tag, and inference stack. Sources: FDA page (Jan 14, 2026)
Build human-in-the-loop safeguards • Map where humans review, override, or arbitrate the AI’s outputs. • Run a small usability study to surface error modes and handoff issues. Sources: FDA page (Jan 14, 2026)
Plan for post-market monitoring • Specify quality metrics you’ll track in the wild (e.g., drift signals, subgroup performance) and when you’ll trigger a recall or revalidation. • Wire these metrics into your PMS plan and risk file so they’re not an afterthought.
Map the principles to your technical file
Create a simple table that maps each principle to an artifact in your dossier. Example rows: • Human-centric by design → Usability protocol + results; human oversight points in workflow; risk controls. • Risk-based approach → Risk file linking harms to claims; test depth matched to risk. • Standards → List of applied standards and why; any justified deviations. • Context of use → Intended use statement; inclusion/exclusion criteria; performance targets. • Multidisciplinary expertise → RACI for clinical, stats, data, and regulatory roles; meeting notes. • Data governance → Data management plan; provenance report; DPA/consent library. • Model practices → Training/validation plan; reproducibility checklist; code and model versioning. • Performance assessment → Statistical analysis plan; benchmarks; reader studies if applicable. • Lifecycle management → Change control SOP; MBOM; release notes. • Clear information → IFU/labeling; limitations; known failure modes and mitigations.
Funding hook
IHI’s new applicant-driven Call 12 is open with €163m, and proposals that show robust data governance, bias testing, and real-world performance monitoring will read stronger to evaluators. Bake the 10 principles into your work plan and budget lines (e.g., for bias audits and post-market analytics).
Quick FAQ on EMA and FDA 10 AI Principles
Is this a binding “guidance”?
No. It’s a set of joint principles. EMA notes it will underpin future guidance and align ongoing EU rulemaking. Treat it as strong direction, not optional reading.
We’re a SaMD company, not a pharma developer—do we care?
Yes, if your AI helps generate evidence in trials or registries, or if the device itself needs lifecycle AI controls. The same reviewers will expect the same hygiene.
What’s the fastest “win” we can ship this month?
Ship the MBOM and change-management SOP. These two artifacts de-risk updates, make audits easier, and force clarity on who does what when models change.
10 AI Principles Mini-checklist (copy/paste)
• Intended use written and testable • Data provenance + representativeness report • Predefined change-management plan (minor vs. major) • Validation plan tied to clinical claims • Human-in-the-loop design + usability evidence • Post-market monitoring metrics and triggers • Versioning/MBOM and audit trail in place
One thing to remember
Harmonisation just got real. If you’re building AI-enabled medtech in Europe, use the EMA–FDA principles to tighten your claims, your validation, and your change control now. You’ll cut review friction later, and your dossier will look like it was written by people who read the rules.
Quiet but productive: seed checks for prevention and preclinical tools, one neat CE mark, and a fresh EU call.
People on the move
Qureight / Rebecca Simmons Ex-Riverlane operator becomes COO to scale the Cambridge clinical-trial imaging platform. [Source]
NanoSyrinx / Thomas Farrell The UK-based intracellular drug delivery innovator appointed Thomas Farrell as CEO to steer its nanosyringe platform from concept to clinic; founder Joe Healey transitions to CSO. [Source]
BICO / Ewa Linsäter The Swedish bio-convergence giant (formerly Cellink) tapped Ewa Linsäter as its new CFO to stabilize financial strategy following a period of aggressive M&A. [Source]
Money flows
ShanX Medtech €24M package (equity, Innovatiekrediet, and €8.85M EC contract by DG HERA and HaDEA) to accelerate validation and EU launch of ultra-rapid infection diagnostics.
Ahead Health $6M Seed, preventive “AI-native” health system; funds expansion across Europe and product development.
FluoSphera €1.23M Seed. Geneva startup scaling an animal-free multi-tissue preclinical platform to speed drug discovery; backing from Soulmates Ventures and others.
On the press
FDA & EMA issue joint AI guidance Regulators on both sides of the Atlantic published a “10 Principles” document for AI in medicine, creating a rare unified framework for lifecycle management and GxP compliance, a massive win for startups tired of dual documentation.
Boston Scientific scores CE Mark for Embold The medtech giant received European certification for its Embold detachable coil system, expanding its neurovascular portfolio for treating stroke and aneurysms in EU centers.
Innovative Health Initiative (IHI) Call 12 The EU’s IHI partnership launched its single-stage Call 12, offering applicant-driven funding (50% public match) for consortia tackling unmet clinical needs—a prime target for startups seeking non-dilutive runway.
ACCESS-AD consortium Amsterdam- and London-led public-private effort kicks off to accelerate Alzheimer’s diagnosis and treatment pathways in European health systems.
One thing to remember
With the new FDA-EMA joint AI guidance, “regulatory harmonization” is finally more than just a buzzword. Smart founders will use these 10 principles to build a single validation dataset that satisfies both watchdogs simultaneously, potentially shaving 12–18 months off their global commercial roadmap
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 itsVan 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.
Deal flow picked up: cardiology workflow hardware gets a seasoned chair, obesity tech hits a pivotal milestone, and Europe leans into AI—from a €10m cross-border programme to NICE nudging digital MSK tools forward.
People on the move
CathVision (Denmark): Eric Thepaut (ex-Boston Scientific EMEA) becomes independent chairman; company also ships ECGenius v3.5 to tighten EP lab workflows.
• FICUS Health (DE): €3M Seed; AI documentation automation for rehabilitation clinics to cut admin time and integrate with German data standards.
• Punto Health (UK/ES): $2.7M Seed; building a speech-AI “OS for dementia care,” with pilots across NHS and Spanish centres.
• ONEHEALTH (NI/ROI): €10M cross-border programme backed by PEACEPLUS to support AI/digital health projects and SME pilots over four years.
On the press
• NICE moves digital MSK forward — Early Value Assessment for digital tools managing mild-to-moderate hip/knee osteoarthritis reached “Resolution,” with publication due Jan 22, 2026. Signal to SaMD teams: evidence + value proposition now.
• Nitinotes (IL/EU) hits pivotal first-patient milestone for EndoZip automated ESG; follows recent CE Mark enabling EU launch. Good read on automation entering bariatric endoscopy.
One thing to remember
The week says “AI with outcomes”: capital is flowing to workflow AI and documentation relief while public funding and NICE processes create room for evidence-led digital rollouts—set your 2026 plan to pair clinical claims with operational ROI and real-world pilots across EU/UK sites.
A compact week: venture debt fuels vascular access, cardiology gets a non-invasive CE mark, and NICE nudges digital rehab platforms toward the NHS.
People on the move
Lucile Blaise joins LivaNova (UK) as Global Head of Commercialization, Obstructive Sleep Apnea, adding strong EU market access chops to the executive team.
Money flows
Xeltis (NL) gets nearly €50M, venture debt + equity; package includes up to €37.5M from EIB (first €10M drawn) and €10M from existing investors EQT Life Sciences and Invest-NL. Funds push aXess vascular access conduit toward EU commercialization.
Angelini Ventures (Italy): €150M EIB co-investment agreement to back European biotech and digital health startups over six years (EIB €75M + Angelini Ventures €75M). Signals more institutional firepower for EU healthtech.
Annette (France) €2M round to scale its GLP-1 companion care platform for structured obesity support; led by Redstone, Ring Capital and AFI Ventures.
Ray Studios (France) €10M to expand its physician-led tattoo-removal clinic network across Europe; co-led by Factory Capital and Nickleby Capital.
On the press
• Cardiawave (FR): Valvosoft® receives CE Mark as the first non-invasive ultrasound therapy for severe symptomatic aortic stenosis; data cited from EU FIM and pivotal studies across 12 centres.
• Boston Scientific: European approval for the Farapoint™ pulsed-field ablation focal catheter to treat atrial fibrillation, complementing Farapulse™ PFA platform.
• NICE (UK) publishes Early Value Assessment (HTE35) for digital platforms supporting cardiac rehabilitation, enabling conditional NHS use while evidence is generated over three years.
One thing to remember
EU cardiology is having a moment: capital is flowing into commercialization-ready devices, while regulators opened the door to earlier adoption of digital rehab and cleared a novel non-invasive therapy. Founders who can pair strong clinical data with payer-relevant outcomes will find both financing and fast-track pathways this winter.
Where the regulations help, the funding flows, and the pilots don’t take geological time
If you ask ten founders where to launch a healthtech startup in Europe, eight will say Berlin, one will say London, and one will whisper Lisbon for “quality of life reasons”. They’re all partially right and all are missing the bigger picture.
Europe isn’t one market. It’s 27 regulatory fiefdoms, three reimbursement philosophies, and a few hundred interpretations of GDPR. Your success depends less on your pitch deck and more on which country actually wants what you’ve built.
Below is your 2025 market map, written for people who need real answers: founders choosing their first market, investors analysing expansion, and operator-types who enjoy pain.
1. France
The most healthtech-friendly major market in Europe
Why France works
Strong government buy-in for digital health.
Funding muscle: Bpifrance, EU4Health, France 2030.
Single-payer structure = easier national rollout.
PECAN (the DiGA-like pathway) actually works.
Best for
Digital care delivery, AI diagnostics, practice management, DTx reimbursement plays.
If your solution is… Data heavy → Nordics / Baltics Reimbursement heavy → France / Germany Consumer-forward → UK Hardware + software → Switzerland / Ireland Cost-sensitive early-stage → Poland / Romania / Spain / Portugal
Europe rewards founders who pick the right first country — not the closest or the coolest. Start where the system actually wants what you’re building.
Europe HealthTech Market Selection Table (2025)
Region
Best For
Strengths
Risks / Caveats
France
DTx, diagnostics, digital care
Strong reimbursement, centralised system, public funding
Bureaucracy and long cycles
Nordics
Remote monitoring, preventive care, data platforms
