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
Oncology operating systems, perioperative risk AI and pre-CT stroke triage all raised fresh capital this week, while Brussels and Munich quietly tightened the screws on AI compliance and imaging vendors celebrated a shiny new CE mark.
People on the move
Ergea Group (Luxembourg) New CEO for pan-European imaging & cancer care
Ergéa, a Luxembourg-based pan-European provider of diagnostic imaging and cancer care services, has promoted David Rolfe from UK CEO to Group CEO and appointed Mark Graves as the new CEO of Ergéa UK, signalling a more integrated European growth push in imaging and radiotherapy infrastructure.
Restore Medical (Israel): ex-Medtronic dealmaker takes the chair
Heart-failure device company Restore Medical (Israel, backed in part by the European Innovation Council Fund) has appointed Chris Cleary, former SVP Corporate Development at Medtronic and architect of the Covidien mega-deal, as chairman of the board to guide its transcatheter heart-failure therapy through advanced US and global clinical development.
Money flows
Gosta Labs (Finland) €7.5M seed, oncology AI operating system Helsinki-based Gosta Labs raised a €7.5 million seed round, led by Voima Ventures with COR Group, the Aho family, Reaktor and other angels, to scale its oncology-focused AI operating system that turns each patient encounter into structured data, slashes documentation time and links care decisions to international treatment guidelines. The company plans to deepen medical-device-grade development and expand deployments across Europe, the Baltics and Australia.
Noteless (Norway) €3.5M to fight doctor burnout Oslo-based Noteless, a Norwegian HealthTech startup automating clinical documentation and task management, closed a €3.5 million round to tackle physician burnout by cutting admin time in hospitals and clinics; the investor syndicate includes People Ventures and Alliance Venture, with the company targeting broader Nordic and European rollout.
Healthplus.ai (NL) €2.3M late-seed for perioperative risk prediction AI Amsterdam-based Healthplus.ai raised €2.3 million in a late-seed round led by Elevating Capital and co-led by LUMO Labs, with ROM InWest and Pathena among the participants, to expand PERISCOPE®, its ISO- and CE-certified AI system that predicts post-surgical infection risk and suggests mitigation strategies for surgical teams. The funding will support deeper EHR integrations (Epic, Cerner, ChipSoft), further model development across perioperative pathways and broader roll-out in Europe plus FDA clearance work for the US.
AI-Stroke (France) $4.6M seed for pre-CT stroke triage Paris-area medtech AI-Stroke secured a US$4.6 million seed round led by Heka (Newfund VC) with Bpifrance and angels, to advance an “AI neurologist” that runs on smartphones or tablets for pre-hospital stroke triage, analysing 30-second video of facial symmetry, arm movement and speech. The capital will fund FDA regulatory work and multisite clinical studies in leading US stroke centres, with the company also adding a heavyweight international stroke advisory board.
On the press
TÜV SÜD launches voluntary EU AI Act conformity certificates
TÜV SÜD announced new services for early, voluntary conformity certificates under the EU AI Act (Regulation (EU) 2024/1689), offering manufacturers of AI systems including high-risk use cases in medicine and medical devices an independent review of technical documentation and partial compliance ahead of mandatory assessments. The program covers gap assessments, training and an “Attestation of Conformity,” aimed at helping companies get AI products AI-Act-ready before notified bodies are fully designated.
GE HealthCare wins CE mark for Omni 128 cm total-body PET/CT
GE HealthCare received CE mark for its Omni 128 cm total-body PET/CT system, enabling commercialisation in the EU of an ultra-long axial field-of-view scanner intended to improve sensitivity, enable low-dose protocols and support advanced oncology and theranostics workflows. The platform is pitched at high-throughput cancer centres and research hubs across Europe.
MHRA outlines “innovative approaches” to medtech regulatory reform
The UK MHRA’s MedRegs blog set out its latest thinking on medtech regulatory reform, highlighting more agile statutory instruments, innovation-friendly approval routes, and closer alignment with international partners for medical devices and IVDs. For EU-facing companies selling into the UK, the piece is a useful signal on future reliance routes and how sandbox-style approaches may coexist with post-market vigilance expectations.
One thing to remember
AI-heavy clinical tools are still getting funded from oncology operating systems to perioperative risk prediction and pre-CT stroke triage. This week’s TÜV SÜD and MHRA moves are a clear reminder that in Europe, “AI-first” now has to mean “AI-and-compliance-first.”
For founders, the competitive edge is shifting toward teams that can show device-grade evidence and be visibly AI-Act-ready long before their product hits a hospital PACS or EHR.
If you work in HealthTech in Europe, you’ve probably noticed something strange. 2024 felt like the world was ending, yet the actual numbers say something very different. Capital didn’t disappear — it simply stopped tolerating nonsense.
Now, in 2025, the money is flowing again, and aggressively so. But it’s flowing selectively.
2024: The Great Reality Filter
Forget the headlines about a funding collapse. What actually happened in 2024 was a reset of expectations. Investors didn’t stop writing cheques, they just stopped writing them for half-baked pitch-deck poetry.
A study analysing ~1,300 funding rounds across European biotech, medtech and digital health showed fewer deals, but bigger ones. Median pre-seed funding actually rose ~15.7% YoY to around €870K, which doesn’t sound like panic to me.
And Q3 2024 alone brought nearly US$2B in HealthTech investment.. The hubs were the usual suspects: UK, Germany, France, with Spain, Portugal and the Netherlands quietly moving up the table.
The hottest segments? Oncology, biotech and AI-powered diagnostics: areas where outcomes are measurable and regulatory paths exist.
Karista summed up the year perfectly: a “reality filter”.
It was not a crash, but a sorting mechanism. The pretenders left the room, the contenders stayed.
2025: Capital Is Back, Smarter
Then 2025 arrived and the mood changed fast.
According to Galen Growth, European digital health funding grew 52% YoY in H1 2025, totalling around US$3.4B across 182 deals. Europe is representing 26% of global funding
Figure 1. European Digital Health Funding Trend 2021–2025 (Indexed) Indexed view using 2021 baseline of 100. 2025 funding growth (52% YoY, US$3.4B H1) based on Galen Growth. 2021–2024 values illustrative, derived from partial public snapshots. Source: disrupting.healthcare
Figure 2. Average Deal Size — 2024 vs 2025 (Relative) Based on publicly reported 3× YoY increase in average deal size (Galen Growth, Healthcare.Digital). Source: disrupting.healthcare
Even more striking: ~65% of all capital went to AI-powered clinical and diagnostic platforms.
Figure 3. Capital Allocation by Segment — H1 2025 ~65% of capital allocated to AI-driven clinical & diagnostic platforms (Galen Growth, H1 2025). Source: disrupting.healthcare
This isn’t a hype revival, but it’s conviction capital. Investors aren’t betting on stories. They’re betting on proof.
The Difference in One Sentence
2024 sorted the real players from the noise. 2025 is paying the real players.
Metric
2024
2025
Deal flow
Reduced volume
Clear acceleration
Average deal size
Reduced volume
€16M
Funding Focus
Biotech, oncology, med-device
AI-clinical & diagnostic
Investor tolerance
Traction required
Validation required
Entry barrier
Brutal
Still high, but capital available
Capital geography
UK, DE, FR
Broader pan-EU activity
What to Do With This Information
If you’re a founder:
If you have validation: raise now.
If you only have a concept deck: don’t waste everyone’s time.
Mix non-dilutive + VC — it’s no longer optional.
If you’re an investor:
Europe is still undervalued vs the US — genuine upside exists.
Secondary acquisitions are coming.
AI is not a theme — it’s now an allocation mechanism.
It’s not 2021 again. 2025 is healthier, clearer, and honestly, more exciting.
Data Methodology & Transparency
The charts included in this article illustrate directional trends in European HealthTech funding rather than precise historical totals. Publicly available data does not provide continuous, fully aggregated funding records across all HealthTech sub-segments (digital health, medtech, diagnostics, biotech) from 2021 through 2024.
The indexed 2021–2025 funding trend chart is a normalized illustrative representation designed to highlight directional recovery and acceleration rather than exact historical volumes. Earlier periods (2021–2024) are estimated using partial public snapshots and normalized to a 2021 baseline of 100 to enable comparison.
The chart communicates trajectory, not absolute values. Where precise historical figures are required (e.g. investor deck, financial report), a consolidated dataset should be constructed from Dealroom / PitchBook / CB Insights / Crunchbase Pro and national grant databases.
Robotics bags big money, IVF gets an automation CE mark, and UK regulators sketch next steps for AI in care.
People on the move
Distalmotion (Switzerland) Chas McKhann becomes Executive Chairman alongside a $150M raise; focus is US growth while keeping EU base in Lausanne.
Money flows
Distalmotion (Switzerland) $150M, Series G / growth; scaling DEXTER® surgical robotics with ASC push and US commercial build-out.
Sofinnova Partners (France) — €650M, flagship Capital XI; early-stage focus in medtech/biopharma, active deployment underway.
On the press
• Overture Life (Spain) CE markfor DaVitri™, billed as the first automated device cleared in the EU or US for vitrifying unfertilised eggs; EU commercial rollout begins.
• Cardiovalve (Israel) CE file submitted for transcatheter tricuspid valve after positive TARGET study interim; EU approval process initiated.
• JenaValve (Germany) 1,000th case with CE-marked Trilogy™ TAVR for aortic regurgitation/stenosis, signalling steady EU adoption.
Capital and credibility still move together: big-ticket robotics funding and a heavyweight €650M early-stage fund arrived the same week that EU-relevant CE activity and the UK’s AI-in-health policy guardrails advanced. It is an evidence that clear regulatory paths plus deployment stories are what unlock cheques right now.
