Category: MedTech

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Digital Health MedTech

Europe MedTech & Digital Health — Weekly Brief (Week of Sep 20–26, 2025, #7)

A brisk week: big wearable debt, a Finland-to-EU CE mark, and fresh regulatory momentum for tinnitus therapy—plus Medtronic doubles down on a London robotics and AI hub.

People on the move

Medtronic Neurovascular: Dr. Adam S. Arthur named Chief Medical Officer, effective Sept 30; brings >20 years’ neurosurgery experience to stroke care strategy.

Olympus (Smart Connected Care): Appoints Slawek Kierner as Chief Digital Officer to accelerate connected-care strategy.

Money flows

Oura (FI): Secured $250M debt facility from a bank syndicate (JPMorgan, Goldman Sachs, BofA, Barclays, Citi, Wells Fargo) to fuel growth and operations. Signals continued appetite for consumer-grade, clinical-adjacent wearables in Europe. Since launching its smart ring in 2015, the company has now sold over 5.5 million units, with more than half of those sales occurring in just the past year.

In addition to record-breaking sales, ŌURA reported more than $500 million in revenue for 2024, representing a more than 200% increase from the previous year.

Ventech (FR/EU): Closes €175M Fund VI to back ~35 European startups across Seed–Series A; mandate spans digital health among other verticals. Good news for early-stage medtech/digital health founders in FR–DE–Nordics.

Co-founder Zoar Engelman, PhD, appointed CEO of Axon Therapies

Axon Therapies (US) $32M Series A to advance heart failure therapy; co-led by Berlin-based Earlybird (EU investor read-through: continued EU GP exposure to cardio devices).

Transmedics OCS - Source: Transmedics.com

TransMedics × Mercedes-Benz (IT/EU): Strategic collaboration to launch Italy’s first dedicated organ-transport ground network (V-Class fleet) across four hubs to scale OCS perfusion logistics; part of broader EU rollout plans.

On the press

Marginum (FI): CE mark (MDR) cleared for HIVEN®, an intraoperative aspirate-tissue monitoring device to aid margin assessment in glioma surgery; Nordic clinical validation noted.

Neuromod Devices (IE): Achieves MDR certification and MDSAP; secures TGA (AU) and Health Canada approvals, ensuring ongoing EU availability and near-term international expansion for Lenire tinnitus therapy.

Medtronic (UK/EU): Doubles London presence to create a global hub for surgical robotics and AI, aligned with NHS 10-Year Health Plan collaboration ambitions.

Anova (UK/US) — Launches a global clinical registry (AnovaOS) for RWE and post-market surveillance—potentially useful for EU MDR PMCF and European study recruitment workflows.

One thing to remember

The week’s signal: European medtech commercialisation is accelerating on two tracks—scale capital (Oura debt, Ventech VI) and regulatory/market access (MDR clearances and global approvals), with major strategics (Medtronic) anchoring AI/robotics hubs in Europe. If you’re fundraising or launching in Q4, tie your story to measurable care delivery gains and MDR-ready evidence.

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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.

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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

AI Security in Healthcare: Europe’s Strategic Fault Line (and How to Win It)

AI Security in Healthcare

AI in healthcare is often sold as a story of improved diagnostics, personalised therapies, and predictive medicine. But beneath that dream lies a fragile backbone: security. One breach, one exploited model, and reputations, finances, even lives are at stake.

In Europe, this tension is amplified. The Artificial Intelligence Act entered into force on 1 August 2024, putting health AI under new obligations (European Commission). At the same time, NIS2 extends cyber resilience rules to hospitals, while the European Health Data Space (EHDS) (in force from March 2025) will demand interoperable, secure data exchange.

This series of posts dissects that tension from five angles:

  1. Why AI in Healthcare Has a Security Problem: Overview of attack vectors, real-world risk, regulatory context.
  2. From MRI to MedTech: Securing AI-Powered Devices: How embedded and edge AI in devices create vulnerabilities.
  3. Pharma Beyond the Pill: AI, Patient Data & the Hacker’s Jackpot: Why pharma’s “beyond the pill” strategies are hacker magnets.
  4. Startups at Risk: The AI Security Blind Spot in HealthTech Funding: Why early-stage ventures often underinvest in security.
  5. Towards Trust: Can Europe Lead on Secure AI in Healthcare?: Can the EU turn trust and compliance into a competitive advantage?
  6. FAQ: AI Security in Healthcare

The future of health AI won’t be won on models — it’ll be won on trust.

Categories
Digital Health MedTech

Europe MedTech & Digital Health — Weekly Brief (Week of September 13-19, 2025, #6)

Chronic care raises capital, CE-marks keep flowing, leadership benches shift, and new data reveals just how underfunded CEE’s healthtech sector remains. I am travelling, so this brief will be, well, brief.

People on the move

Venous Stent B.V. — Darren Spencer appointed CEO to drive its iliac venous stent programme into first-in-human trials and through EU regulatory milestones. NLC Health (Sep 2025)

Data4Life (Germany) — Dr. Ben Illigens named CEO to scale its health data platform (Data2Evidence) and tighten focus on compliance and translational research. Yahoo / Data4Life (Sep 1, 2025)

Money flows

Doctor.One (Poland/Europe) — €4M Seed led by YZR Capital with Impact Ventures and existing investors. The asynchronous chronic care platform is expanding into Germany, Spain, and the UK, with pharma partnerships already underway. EU-Startups (Sep 17, 2025); EIT Health (Sep 17, 2025)

On the press

  • Johnson & Johnson Shockwave Javelin Catheter Launch — New peripheral intravascular lithotripsy catheter hits Europe, promising better outcomes for below-knee calcified lesions. Johnson & Johnson (Sep 15, 2025)
  • Roche SmartGuide + mySugr CE Mark — CE approval for Roche’s Accu-Chek SmartGuide CGM integrated with the mySugr app; rollout planned across multiple EU markets. Biospace (Sep 17, 2025)
  • AVITA Medical RECELL GO CE Mark — CE approval expands European access to RECELL GO burn care device. BioPharma Boardroom (Sep 15, 2025)
  • CEE Funding Gap Report — New EU-backed investor guide highlights that CEE health ventures raise on average €1.8M vs €4.1M across Europe, and the region captures only 3.9% of EU’s VC funding. Medvia (Sep 12, 2025)

One thing to remember

Capital is flowing, but not evenly: while Western Europe powers up chronic care and device launches, CEE healthtech founders remain chronically underfunded. For investors, this looks like arbitrage. For founders, it means sharper evidence, earlier partnerships, and bolder cross-border strategies will be key to attract scale-up capital.

This content has been enhanced with GenAI.


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Digital Health MedTech

Europe MedTech & Digital Health Weekly Brief (Week of September 6–12, 2025, #5)

Workflow AI meets hard regs: funding into clinical workforce & pathology AI, a CEE mental health roll-up, and CE marks in resuscitation, MSK and neuro-mobility.

People on the move

Haughton Design (UK) appoints Dr. Ash Ghadar as CEO to scale medtech/drug-delivery design services; a reminder that device commercialisation chops are in demand.

Allianz Partners (FR) names Okan Özdemir Chief Officer for Health & Board Member; payer-side signal for digital health distribution.

Money flows

Teton.ai (DK) $20M Series A, predictive eldercare AI; Plural leads with Bertelsmann Investments, Antler Elevate, Nebular and PSV Tech. Funds to push EU/US rollout and dataset expansion.

TERN Group (UK) €20M Series A; AI clinical workforce platform to optimise staffing across Europe & GCC; led by Notion Capital with RTP Global, LocalGlobe, EQ2, Leo Capital et al.

Aiosyn (NL) €2.4M to advance AI pathology tools for cancer diagnostics; supports validation and productisation with Dutch partners.

SafeHeal (FR) €10M Series C extension led by Asabys to accelerate EU commercial launch of Colovac and continue U.S. study.

Hedepy (CZ) acquires Poland’s HearMe (terms undisclosed) to consolidate CEE online psychotherapy; adds 80+ corporate clients and 120+ professionals; founders join leadership

On the press

• Neurescue (DK) wins CE mark under MDR for its intelligent aortic balloon catheter; the first device approved to treat non-shockable cardiac arrest in Europe.

• Varian (Siemens Healthineers) secures CE mark for Embozene microspheres in genicular artery embolisation (GAE) for knee osteoarthritis; first CE-marked embolic for GAE.

• Lifeward (IL/US) gains CE mark for ReWalk 7 personal exoskeleton; EU commercial launch enabled, with Germany a key reimbursed market.

• Report: Europe’s 10 biggest healthtech deals in H1 2025: €4B raised; UK led by volume. Useful late-stage context.

One thing to remember

Regulatory traction is back: three CE marks in one week (resuscitation, MSK pain, neuro-mobility) while capital flowed to workflow AI (staffing, lab data) and pathology. EU buyers will reward products that unblock staffing, data, and function bottlenecks.

This content has been enhanced with GenAI.

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