AI pathology and precision health get fresh fuel; MDR CE marks stack up; MHRA drops safety signals and an IDAP tweak—another week of pilot-to-product momentum.
People on the move
ViCentra (the Netherlands) Ex-Dexcom and Medtronic leaders join to scale Kaleido across Europe; Karen Baxter becomes SVP Sales, Europe; Jay Little becomes VP Strategy & Business Development.
• Lumendi EU MDR CE mark for DiLumen™ EZ¹ and DiLumen™ C¹ endotherapy devices; enables EU commercial distribution.
• Bot Image MDR CE mark for ProstatID® AI prostate MRI software, opening European market access; product is FDA-cleared in the U.S.
• MHRA — October Safety Roundup and Field Safety Notices published; useful for vigilance teams.
• MHRA — IDAP update: UCNA extension for HistoSonics’ EDISON™ ultrasound ablation system; worth tracking alongside EU MDR routes.
One thing to remember
Regulatory momentum matters: CE marks keep landing while the UK fine-tunes access pathways, and capital is returning tohiow focused clinical AI and women’s health sensors. Founders who tie clinical utility to crisp EU/UK access narratives will convert faster to distribution.
Valuation isn’t everything but in healthtech, it tells you who’s still scaling
Let’s not pretend valuation is the ultimate success metric. But it is a decent proxy for where capital, confidence and commercial traction are flowing. Especially in a market as fragmented and overregulated as European healthcare.
The 2025 leaderboard of Europe’s top 10 most valuable healthtech companies.
Not biotech. Not pharma. Just tech-enabled health. Companies at the intersection of software, care and medical delivery models. Most are private. A few are flying under the radar. And yes, Finland opens the list.
Valuation: US$11 billion (Sep 2025) What it does: Smart wearable ring + health analytics Why it matters: Europe’s wearables play moving into serious health data.
Valuation:US$6.4 billion (2025 ranking) What it does: Appointment booking and telehealth platform for European health systems. Why it matters: A dominant platform reaching scale across French & German markets, signalling what digital health infrastructure looks like in the EU.
Valuation: US$4 billion (June 2025 funding round) What it does: AI-enabled digital therapy / musculoskeletal care Why it matters: Bridges digital therapeutics and service delivery with high value healthcare cost savings.
Valuation: Reported ~US$2 billion What it does: Telemedicine/virtual primary care (marketed as “Livi” in UK/France) Why it matters: One of the larger pan-European virtual care plays.
Valuation: Reported >US$1 billion (source) What it does: Tech enabled home care & community services Why it matters: A service delivery business scaling across UK homecare, a difficult but high impact node of the health system.
Valuation: ~US$1 billion What it does: Women’s health (cycle tracking, fertility, health analytics) Why it matters: Rare consumer digital health “scale” platform in Europe with global ambitions.
Valuation: ~US$1.8 billion What it does: Full body scanning diagnostics with AI Why it matters: Diagnostics and proactive screening is one of the less hyped but high upside segments in EU healthtech.
Valuation: ~US$600 million (estimate) What it does: Wearable insulin delivery device + patient engagement Why it matters: Device + digital combo in chronic disease management
Valuation: ~US$300 million (estimate) What it does: Continuous blood pressure monitoring without cuffs Why it matters: Remote monitoring is crowded, but clinically meaningful, reimbursable models still rare.
Valuation: ~US$150 million (estimate) What it does: Smart ambient care sensors for elderly living at home Why it matters: A realworld aging play; modest valuation, but high relevance for Europe’s demographic shift.
What this list tells us?
Valuation follows integration. The highest valued companies are those who figured out how to embed into care delivery systems, not just launch a product or service. It’s not just software. Many of the names here incorporate hardware or device components, but the business model leads with experience, outcomes, and scale. Europe has range. From Portugal to Sweden to France, the value creation is not limited to London/Berlin (though they still matter). But caution remains. Private valuations are fluid. Some said “decacorn” for Oura a year ago; latest official validated valuation is half of it at around ~$5.2bn the jump to ~$11bn comes from news speculation.
One Last Note
This list isn’t final, and it will change, maybe an hour after the publication. Private valuations shift. Some firms may consolidate or pivot. But if you’re looking to invest, compete or expand — these are the healthtech companies dominating European healthtech headlines for now.
Next up: where the money’s coming from — and who’s still writing the big cheques.
What’s scaling, who’s paying, and why you should care
Let’s start with a question. What do Oura, Sword Health, and Doctolib have in common?
If you said “healthtech unicorns” you’re technically right, but that’s not the real answer. The real answer: they’re European, they’re growing like weeds, and most investors or founders still talk about them like they’re niche side projects.
Which is odd. Because these are the companies quietly shaping the future of healthcare on the old continent, while half the market’s still arguing about whether DiGA is dead or just very German.
So, I’ve put together something to help.
This is Mapping the European HealthTech Goldmine. A five-part series for anyone building, backing, or expanding healthtech in Europe.
Why now?
Because the money’s back.
After the hangover that was 2023, last year saw European healthtech bounce to around $4.8 billion in VC funding. This year? $4.3 billion in Q1 alone, and that’s not even counting what gets tucked into medtech, diagnostics, or things with “AI” bolted on just to close a round.
The capital is flowing. But, and this is where it gets interesting, it’s not flowing evenly.
It’s going to:
A handful of markets (Finland? Really? Yes.)
A small set of models (wearables, MSK, diagnostics-as-a-service)
And companies that figured out how to integrate with public health systems without losing their will to live.
What you’ll actually get
No vague “trends”. No breathless “disruption” language, this you have in the name of this website. I offer just five posts that get to the point:
What Europe’s HealthTech Winners Did Differently (Besides surviving long enough to be acquired.)
Who this is for
If you’re a founder, an investor, or someone trying to scale something in European healthcare without losing your shirt — this is for you.
Especially if you’re tired of reading loud headlines about $20M Series A rounds in the US and wondering why your reimbursement pilot takes 18 months and a PowerPoint deck for the bored Ministry officials.
Read it, steal ideas from it, or forward it to your CFO
The first post, the top 10 most valuable healthtech companies in Europe goes live next.
After that, one post a week, give or take. Short reads. Linked data. Unapologetically European perspective.
If that sounds useful, subscribe, bookmark, or just come back with coffee.
Funding stacked, boards shuffled, CE marks landed — this week runs on neurotech raises, workflow monitors, and regulator backed AI.
People on the move
Cardiawave (France): Jonathan Freeman becomes Board Chair as the French non invasive ultrasound outfit gears up for global expansion.
CoMind (UK): Taavet Hinrikus, partner at Plural joins the board alongside the new round, bringing company building and scaling firepower.
Money flows
ONWARD Medical (UK): €50.85M private placement. Neurostimulation for spinal cord injury. Proceeds go to ARC IM development, ARC EX commercial build out in the US and Europe, and operations runway into late 2026.
CoMind (UK): 60M USD growth round. Non invasive brain monitoring to replace surgical holes for neuromonitoring. Backers include Plural and Taavet Hinrikus who also joins the board.
Calm Storm (Austria): €30M new fund close. Vienna based fund doubles down on health and digital across CEE and DACH with pre seed through seed checks.
Cyclana Bio (UK): £5M pre seed. Women’s health discovery platform for endometriosis using tissue level models and AI. Co led by NfX and Eka VC.
Median Technologies (France): Financing update. Received €19M first tranche from the European Investment Bank agreement on Oct 20 and highlighted earlier €23.9M capital increase to extend runway to at least Q4 2026 while preparing US launch of its AI lung cancer SaMD.
On the press
• GE HealthCare: CE mark for Carevance patient monitor, adding cardiac output insights for perioperative care, with European showcase at ESICM Munich. • MHRA: New AI projects to predict side effects from drug interactions and speed safer treatments. Signals growing UK emphasis on applied AI across medicines and devices. • Femasys: Initiates EU post market surveillance for FemBloc permanent birth control, a step in the MDR commercial plan for Europe. • Chronic care watch: Useful macro lens on why chronic care is the next healthtech frontier and where founders can build. Helpful context for EU markets leaning into long term conditions.
One thing to remember
Follow the money into clinically close, workflow ready tech. Neuro monitoring, perioperative hemodynamics, and women’s health discovery drew fresh capital or clearances, while regulators nudged AI into practical safety use. Founders who pair hard clinical value with clean MDR playbooks will find doors open this quarter.
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.
Omnichannel in MedTech usually means a half-baked app, an email campaign, or a portal nobody uses. ZEISS changed the script.
In March 2025, ZEISS launched its EyeCare Network and quietly took a €10 million stake in Ocumeda, a tele-ophthalmology platform connecting 700 optical stores to 300,000 patients. Retail stores. Welcome to the new front line of diagnostics.
What’s Happening in Stores
The journey starts when someone walks into an optician’s shop to get new glasses. Instead, they’re offered a medical-grade eye check using ZEISS devices like the VISUREF 1000. That data is sent to a licensed ophthalmologist through Ocumeda’s secure platform. Within hours, the patient gets a validated medical opinion.
This is more than a tech pilot:
120,000+ screenings already done in Germany.
700+ sites onboarded.
Rollout underway in Austria and Switzerland.
Retail is becoming the gateway to care. Not the follow-up. The entry point.
Why This Is True Omnichannelin MedTech
Most omnichannel talk is just marketing. ZEISS is building infrastructure.
Retail as healthcare touchpoint
Hardware + software + clinical validation
Training and support for store staff
GDPR-ready workflows from day one
Every part of the journey — from store to cloud to clinic — is tightly integrated.
Why ZEISS Bought a Piece of the Ocumeda Platform
ZEISS didn’t stop at integration. It bought 10% of Ocumeda, with the option to go to 25%. This isn’t a partnership but a vertical integration.
Owning a slice of the platform means:
More influence over features, pricing, data standards
Tighter alignment between devices and digital workflows
Protection from being locked out by third-party platforms
Think Apple with its chips. Tesla with batteries. ZEISS wants the same control in MedTech.
Where It Could Go Wrong
The model works. But scaling it won’t be easy. Risks include:
Channel tension – Will ophthalmologists feel replaced?
Quality variation – Can every optical shop maintain high standards?
Data governance – Who owns the patient data?
Regulatory fog – Is a retail “screening” still a medical act?
EU complexity – Rules change across borders. Fast.
The challenge isn’t the tech. It’s alignment on legal, operational, and clinical level.
For MedTech practitioners it has one more caveat. Vision Care has retail element while other areas such as Orthopedics, Specimen Management, Medication Management are pureplay B2B.
FAQs: What You Need to Know
Is this reimbursed care?
Not yet. It’s mostly out-of-pocket, but early signs show willingness to pay for convenience and speed.
Is ZEISS building a competitor to ophthalmology clinics?
No. It’s offering pre-screening. Final decisions still rest with licensed doctors.
Why is this different from telehealth apps?
Because it integrates physical diagnostics, real medical devices, and human oversight, not just video calls.
Could Zeiss Vision Care model scale to other specialities?
Any field with simple tests, decentralised screening potential, and device-led data capture could follow suit.
What Other MedTech Companies Should Learn
This isn’t about gadgets. It’s about building a system where:
Devices become data sources.
Stores become clinics.
Platforms become the product.
If you’re still pushing apps with no backend, portals with no users, and devices with no data strategy, you’re not doing omnichannel. You’re doing PR.
Final Takeaway
ZEISS is turning the optical shop into a diagnostic hub and buying into the data backbone that powers it. This is what real omnichannel looks like in MedTech, where the product is the experience, and the device is just the entry point. Own the gateway. Or someone else will.
Key Developments, Funding Rounds, Launches, and Regulatory Updates
This week in European MedTech and Digital Health has seen steady progress, with notable funding rounds, product launches, regulatory milestones, and leadership changes. Key highlights include the debut of a new ECMO system, a cardiology AI solution achieving its CE mark, and enhanced regulatory cooperation between the UK and the US on AI and medical devices.
People on the Move
PBC Biomed (IRL): Mark McMahan has been appointed Chief Commercial Officer to accelerate go-to-market strategies for trauma and extremities products in the EU and US.
The Medical Travel Company (UK/India): Raised €3.8 million in a round led by Nexus Venture Partners, with participation from athlete collective 4CAST. The company focuses on building regulated cross-border care pathways for UK patients to access accredited providers in India. The new funds will support deeper partnerships in the UK and the certification of care pathways.
Fellos (NL): Secured €2.0 million in growth capital to expand its men’s health telemedicine services, specifically targeting erectile dysfunction and premature ejaculation. The funding will enable the company to scale operations in the Netherlands and broaden its service offering. Investors include healthcare professionals, Dutch Operator Fund, and Capital Mills. (7/10/2025)
NP-Hard Ventures (NL): Announced a €25 million first close for Fund II, targeting European technical founders in deeptech and automation. The fund’s remit covers medtech infrastructure and robotics—providing vital capital for enabling tools in clinical and device workflows.
Anasens × MAVAND: The two companies have entered into a distribution agreement for DrugAsens™ across selected EU markets and Australia. The partnership covers joint go-to-market strategies, training, and post-sales support.
Product Launches and Regulatory Updates
Medtronic: Launched the VitalFlow ECMO system in Europe—a one-system platform debuting at EACTS in Copenhagen. This innovation expands options for ICU and intra-hospital transport of critical care patients.
Vektor Medical: Secured the CE mark for vMap, an AI-assisted, non-invasive arrhythmia mapping product based on 12-lead ECG data, now entering the EU market. This technology has the potential to streamline electrophysiology workflows.
Philips: Achieved a milestone with the 5,000th installation of its Zenition mobile C-arm, with the milestone site at Kolín Regional Hospital in the Czech Republic.
UK MHRA & US FDA: Announced a deeper collaboration on medical technologies and AI, including new reliance routes and the creation of a National AI Commission. This alignment aims to speed up safe access to innovative devices.
Key Takeaway
The combination of commercial momentum and regulatory support is paving the way for faster adoption of new technologies in Europe. With the launch of ECMO and arrhythmia-mapping solutions and closer UK–US regulatory alignment, companies should focus on products that improve clinical workflow efficiency and meet notified-body evidence requirements. Investors are encouraged to keep an eye on infrastructure and peri-procedural AI, as these segments are transitioning from pilot phases to procurement.
The European Commission’s latest 150-page analysis of artificial intelligence deployment in healthcare across the EU isn’t light reading. But it should be mandatory for anyone building or backing AI-driven MedTech. Because while the headlines scream about generative AI revolutionising medicine, the report paints a far less dramatic, but more commercially useful, picture.
This is a story of uneven adoption, promising use cases strangled by red tape, and the growing chasm between regulatory intention and real-world execution. In other words, typical European healthcare.
The Few Use Cases That Work
Despite the hype, only a narrow set of AI applications are actually scaling:
Imaging and diagnostics continue to lead, especially in radiology, pathology, and dermatology. This is due to data abundance and well-defined clinical tasks.
Operational AI is quietly making a difference in logistics and scheduling, especially tools that improve patient flow or reduce no-shows.
Administrative automation using LLMs and NLP is gaining traction, particularly digital scribes and documentation tools.
In all cases, the successful deployments are narrow, specific, and integrated into existing workflows. General-purpose AI or standalone platforms are still a fantasy.
Why Adoption is Stalling
The study outlines 26 distinct barriers. Let’s group the key ones:
1. Data fragmentation and access
Hospitals operate with siloed systems and non-standardised formats. Even when data is available, trust, consent, and governance issues make it unusable.
2. Overlapping regulation
MedTech startups must navigate the AI Act, GDPR, MDR, IVDR, HTA rules, and soon the EHDS. Each imposes its own requirements for transparency, explainability, evidence, and liability.
3. Procurement paralysis
Hospitals rarely procure standalone AI tools. They prefer solutions bundled with existing systems or validated by public-private pilots. That means startups must either integrate into incumbent platforms or navigate years-long public tenders.
4. Lack of robust evidence
Most AI tools lack RCTs or real-world data at scale. This stalls reimbursement and formal adoption. And since HTA bodies treat algorithms like drugs, the evidentiary bar is high and expensive.
5. Cultural resistance
Doctors are wary of black-box tools. Patients aren’t convinced about machine-made diagnoses. And hospital administrators need guarantees, not hype.
Strategic Insights for EU Founders
If you’re a MedTech founder in Europe, here’s what to take away:
Build for integration: Design your AI to plug into Cerner, Epic, or national EHR systems. Standalone platforms won’t survive.
Focus on unsexy wins: AI that reduces admin, improves scheduling, or boosts documentation accuracy is easier to validate and adopt.
Use hospitals as research partners: Academic centres want to publish. Co-develop your real-world evidence with them.
Service, not software: Hospitals want solutions, not licenses. Offer managed services, not just tools.
Treat CE mark as step one: It’s not product-market fit. It’s the starting point for evidence and integration.
What Investors Should Look For
Smart capital should prioritise teams who understand Europe’s slow path to adoption. Key signals include:
Integration-ready architectures
HTA or payer engagement early on
Built-in data governance and local validation
Evidence generation baked into the roadmap
If a startup claims AI disruption without regulatory or clinical depth, pass.
A Final Word
AI in EU healthcare is not a gold rush. It’s a policy-anchored trench war. But for the few who master the terrain, the rewards are durable. Think less blitzscaling, more systems change. Just don’t call it a revolution. In Europe, it’s called compliance.
In medtech, digital transformation isn’t optional. It’s survival. Yet for all the noise about AI-driven journeys and seamless customer experiences, even the top players are still building the plane mid-flight.
So what can smaller European medtech companies learn from the current leaders? I reviewed the publicly available cases of digital and omnichannel strategies of three global giants Medtronic, Siemens Healthineers, and Stryker to surface actionable insights and best practices.
Medtronic: Building Ecosystems, Slowly
Medtronic remains the largest medtech company by revenue. But when it comes to omnichannel, it’s evolving cautiously.
What they’re doing:
Co-marketing with Siemens Healthineers on the Multitom Rax imaging system as part of the AiBLE spine ecosystem (source).
Leveraging social media, clinician education tools, and content platforms to increase reach and engagement (case study).
What’s missing:
No visible digital marketplace or open ecosystem for partners.
Limited public evidence of AI-driven personalisation or predictive content.
Ecosystem thinking is valuable, especially in surgical or complex therapies. But without deep digital integration, especially around the customer journey, the ecosystem risks being a brochure, not a behaviour driver.
Siemens Healthineers: The Platform Pioneer
Siemens Healthineers offers perhaps the most mature digital and omnichannel setup among major medtech players.
What they’re doing:
Operate a Digital Marketplace that enables customers to explore, demo, and procure software solutions from Siemens and third parties (source).
Use Bynder DAM to centralise content across regions and channels (source).
Build audience-based personalisation using Adobe tools (source).
What’s missing:
Real-time sales integration and next-best action logic remain largely invisible.
Little public info on commercial outcomes (conversion lift, sales acceleration).
You might not build a full marketplace, but the lessons around content centralisation and partner integration apply universally, especially to smaller firms with limited resources.
Stryker: Agile Personalisation at Scale
Stryker isn’t the biggest, but it punches above its weight in digital marketing innovation.
What they’re doing:
Reportedly implemented AI-driven content personalisation, boosting engagement by 50% and cutting costs by 25% (source).
Use marketing automation tools to deliver educational content to clinicians and reps (source).
What’s missing:
Limited visible platform strategy; more campaign-centric than ecosystem-driven.
Attribution and full-funnel metrics remain hard to trace.
Stryker shows how even non-software-heavy medtechs can benefit from AI and automation. Start with content relevance. Scale later.
Learnings and Best Practices for European MedTech Marketers
1. Centralise your content before you personalise. Don’t jump to AI before you’ve cleaned up your content chaos. You need a workable Digital Asset Management setup.
2. Think ecosystem, not brochure. Medtronic’s AiBLE play works because it ties devices to a procedural journey. Even small firms can do this by connecting education, support, and product content into a workflow. Dont’t make artifical breaks between marketing, sales enablement and post-sale support.
3. Use digital to empower field, not replace it. True omnichannel means your rep knows when someone opened the email, attended the webinar, or downloaded a manual. Feed that data back to the front line, improve on data and feedback.
4. Focus on one journey and automate it well. Pick a narrow use case like onboarding surgeons to a new device and build a full journey. Then automate and replicate. Don’t try to boil the ocean.
5. Measure what matters. Don’t stop at clicks. Track whether digital engagement shortens sales cycles, improves training uptake, or drives service revenue.
Final Thought
The leaders aren’t perfect. Most are still struggling with full integration, attribution, and ROI. But they’re moving. And in medtech, movement is momentum. If you’re a European SME, you don’t need a marketplace or AI engine to start. You just need a map, a message, and the will to connect the dots.
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.
