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Digital Health MedTech

Europe MedTech & Digital Health Weekly Brief (Week of 4–10 October 2025, #9)

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.

Merz Therapeutics (DE): The company has opened a new affiliate in Poland, with Jolanta Dilling-Sulimierska stepping in as General Manager to lead local expansion efforts.

Investment and Funding Activity

  • 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.

This content has been enhanced with GenAI

Sources

https://www.eu-startups.com/2025/10/cricket-stars-help-raise-e3-8-million-for-the-medical-travel-company-and-its-cross-border-healthcare/

https://www.eu-startups.com/2025/10/dutch-mens-health-startup-fellos-lands-e2-million-to-tackle-sensitive-issues-like-ed-and-pe-through-telehealth/

https://siliconcanals.com/np-hard-ventures-launches-e25m-fund-ii/

https://news.medtronic.com/Medtronic-Cardiac-Surgery-launches-VitalFlow-TM-Extracorporeal-Membrane-Oxygenation-ECMO-system-in-Europe%2C-advancing-care-for-critically-ill-patients

https://www.businesswire.com/news/home/20251007948309/en/Vektor-Medical-Secures-CE-Mark-for-vMap-Bringing-the-Benefits-of-Non-Invasive-Arrhythmia-Mapping-to-Europe

https://www.gov.uk/government/news/patients-to-benefit-as-uk-and-us-regulators-forge-new-collaboration-on-medical-technologies-and-ai

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Digital Health MedTech

AI in EU Healthcare: Bureaucracy vs Opportunity

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.

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Digital Health MedTech

Omnichannel in MedTech: What Europe’s Top Players Can Teach You

What Leading MedTech Companies Can Teach about Omnichannel Marketing

Everyone talks about omnichannel. Few do it well.

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.

This content has been enhanced with GenAI.

See also:
Complete Guide to Omnichannel Marketing in Pharma and Medtech

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Digital Health MedTech

Europe MedTech & Digital Health Weekly Brief (Week of Sep 28–Oct 4, 2025, #8)

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.

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Digital Health MedTech

Pharma Beyond the Pill: AI, Patient Data & the Hacker’s Jackpot

Pharma wants real-world data; adversaries want it more.

Case Studies

  • MyFitnessPal breach (2018): 150m accounts compromised — a reminder of health data’s value (TIME).
  • Flo Health (2021): settled with US FTC for sharing sensitive reproductive data despite promising privacy (FTC).
  • Flo Health (2025): faced new lawsuits; a California jury also found Meta liable for collecting Flo user menstrual data without consent (Reuters).

Risk Hotspots

  • Insecure APIs/model endpoints
  • Sensor spoofing
  • Third-party SDK vulnerabilities
  • Cross-border transfers under GDPR special category rules

Mitigations

  • Privacy by design (minimise, pseudonymise, differential privacy)
  • Strong auth & rate limiting
  • TLS + encryption at rest
  • Transparency & explainability
  • Dependency vetting
  • Incident response aligned to GDPR & AI Act timelines

Your real-world data strategy is only as strong as your real-world security.

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Digital Health MedTech

Startups at Risk: The AI Security Blind Spot in HealthTech Funding

VCs love TAM slides. Users love not being breached.

Why Startups Under-Secure

  • MVP pressure, scarce resources, misaligned incentives
  • Lack of security expertise on early teams
  • Investor pressure to scale fast

Investors Waking Up

  • Some VCs now include security diligence checklists.
  • EU accelerators and Horizon programs require security roadmaps.
  • Compliance overhead from AI Act + NIS2 makes neglect unsustainable (European Commission).

Diligence Questions

  • Threat model?
  • Training data integrity?
  • Drift detection?
  • Audit trails?
  • OTA security?
  • DPIA performed?

Minimal Security Stack

  • IAM with least privilege
  • Encrypted storage/transit
  • ML provenance tracking
  • Logging & audits from day one
  • Version gating
  • Light adversarial sweeps
  • Incident response playbook

Secure runway beats growth at any cost, especially in health.

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Digital Health MedTech

Towards Trust: Can Europe Lead on Secure AI in Healthcare?

Europe wrote the rules. Now it has to monetise them.

The EU Stack

Why It Can Be a Moat

  • “Secure by design” branding
  • Regulatory export advantage
  • Procurement preference for certified solutions
  • Public trust premium

Risks & Tensions

  • Overregulation chilling startups (Harvard Petrie-Flom)
  • Fragmentation of enforcement across Member States
  • Standards lagging behind attack vectors

If Europe aligns security, standards, and procurement, trust becomes a market advantage — not a compliance tax.

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Digital Health MedTech

FAQ: AI Security in Healthcare

Is AI safe to use in healthcare?

AI can improve diagnostics, treatment recommendations, and patient monitoring but without safeguards it can be manipulated. Adversarial attacks on medical imaging AI have been shown to cause misclassifications (European Journal of Radiology).

The EU recognises this: under the AI Act, most health AI is “high-risk” and must meet requirements for risk management, logging, transparency, and human oversight (European Commission).

What makes healthcare AI especially vulnerable?

  • High-value data: medical records and biomarkers can be monetised.
  • Legacy IT systems: hospitals often run outdated software.
  • Safety-critical use cases: an AI mistake can harm patients.

A striking example: the WannaCry ransomware attack (2017) disrupted the UK NHS, cancelling appointments and locking critical systems (UK National Audit Office).

What regulations apply to AI in healthcare in Europe?

  • AI Act (2024) high-risk AI systems must comply with strict risk, logging, and oversight rules (European Commission).
  • MDR/IVDR safety and performance rules for devices, including AI-powered ones.
  • NIS2 Directive (2023) cybersecurity rules for hospitals and health infrastructure (European Commission).
  • European Health Data Space (EHDS) secure EU-wide health data access and exchange from 2025 (European Commission).

What real-world health data breaches should I know about?

  • MyFitnessPal (2018): 150m accounts exposed (TIME).
  • Flo Health (2021): settled with US FTC for sharing sensitive reproductive data without consent (FTC).
  • Flo Health (2025): faced new lawsuits; a California jury also found Meta liable for illegally collecting Flo users’ menstrual data (Reuters).

These cases underline that health data is both sensitive and heavily scrutinised.

What can startups do to avoid AI security pitfalls?

  • Secure training data integrity
  • Audit trails from day one
  • Adversarial testing
  • Incident response plans
  • Data Protection Impact Assessments (DPIAs) under GDPR

Investors increasingly check these; a weak security posture is becoming a deal-breaker.

Can Europe lead on AI security in healthcare?

Yes, if it turns regulation into a competitive advantage.

Europe’s bet is that “trustworthy AI” will attract hospitals, regulators, and patients. If secure-by-design becomes the norm, EU firms may gain a global edge, provided compliance doesn’t strangle startups.

In healthcare, AI is only as valuable as it is trustworthy. Europe is trying to legislate that trust into existence.

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Digital Health MedTech

Why AI in Healthcare Has a Security Problem

Every health AI model is a decision engine — and an attack surface.

The Risks (with Evidence)

  • Adversarial examples derail medical imaging AI — systematic review across radiology (European Journal of Radiology).
  • Data poisoning, inversion & extraction are recognised clinical AI risks with mitigations like audit trails and continuous monitoring (García-Gómez et al.).

Why Healthcare Is Special

  • High stakes, legacy networks, and fragile systems — the WannaCry ransomware attack disrupted NHS care at scale (UK National Audit Office).

Framework for Defence

  1. Threat modelling & asset inventory
  2. Data integrity controls
  3. Access isolation
  4. Logging & audit trails
  5. Drift monitoring
  6. Adversarial testing
  7. Rollback plan

Aligned with the EU AI Act’s high-risk obligations: risk management, logging, human oversight (European Commission).

In healthcare, AI isn’t “just software” — it’s safety-critical infrastructure.

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Digital Health MedTech

From MRI to MedTech: Securing AI-Powered Devices

Your pacemaker is now an endpoint. Attackers read release notes too.

Why Devices + AI Are Tricky

  • Firmware–model coupling, edge inference, constrained compute, long lifetimes.
  • Risks mapped in Biasin et al.’s study on AI medical device cybersecurity (arXiv).

Case in Point

The 2017 firmware recall for ~465k Abbott (St. Jude) pacemakers shows the stakes, a patch was issued to mitigate RF cybersecurity vulnerabilities (Read more).

Regulatory Overlap

  • AI used for medical purposes typically lands in high-risk under the AI Act, layering obligations on top of MDR/IVDR (European Commission).
  • This includes logging, robustness, and human oversight.

Secure Design Patterns

  • Isolation/sandboxing
  • Secure boot + model integrity checks
  • Fail-safe fallback modes
  • Lightweight cryptography
  • Device logging & anomaly detection
  • OTA updates with rollback
  • Adversarial robustness testing

Ship devices with a patch plan, audit trail, and model provenance. Or don’t ship at all.