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.
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
Threat modelling & asset inventory
Data integrity controls
Access isolation
Logging & audit trails
Drift monitoring
Adversarial testing
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.
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:
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.
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.
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.
• 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.
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.
Think AI alone is transforming healthcare? Think again. The real game-changer could be quantum computing, particularly when paired with supercomputers. This isn’t future fiction anymore. It’s happening now.
What’s New—and Why It Matters
Combining quantum computing and supercomputers enables molecular simulations, like insulin dynamics involving tens of thousands of orbital. Classical systems simply could not handle it.
Experts are calling this the “AI on steroids” era, and the real test is whether quantum hardware can catch up to the hype.
Expected impact: quantum systems promise to make drug development far more accurate and efficient than ever before.
Strategic Insight—Why It Matters for European Commercialisation
Regulation won’t slow us down: Quantum tools could help Europe leapfrog red tape by enabling faster, in-silico trials and predictive toxicology.
Startups must recalibrate: As this tech moves from testing labs to real-world deployment, funding and venture strategies must shift, think hybrid infrastructure, not cloud-only or chip-only bets.
Policy windows opening: EU research programmes (e.g., Horizon Europe, Digital Europe) could be primed to support hybrid computing capabilities as they realise their impact on healthcare ROI.
What Are the Challenges? (Because of course there are.)
Hardware still nascent: Supercomputer capacity is real—but quantum hardware still lags and faces error-correction hurdles. “AI on steroids” isn’t quite combat-ready yet.
Integration complexity: Hybrid systems bring technical, regulation, and cost challenges, especially for SMEs.
Talent crunch: Few European researchers bridge computational chemistry, quantum algorithms, and AI. Building that capability will be critical.
Quantum‑supercomputer hybrids aren’t tomorrow’s sci‑fi. They’re today’s infrastructure for slashing decades off MedTech R&D. Don’t sleep on this. Europe’s commercial edge will go to those who code quantum-native, not just cloud‑native.
Europe is not just a consumer of quantum technologies, it’s investing heavily to become a global leader. The Quantum Technologies Flagship commits €1 billion over 10 years to research and commercial pilots.
Add Horizon Europe and EuroHPC’s hybrid supercomputers, and you get a uniquely European playbook: strong public co-funding, national champions, and cross-border infrastructure.
Key hubs include:
France: Pasqal, a neutral-atom hardware leader, and Qubit Pharma, focused on quantum drug discovery.
Finland: Algorithmiq, developing quantum algorithms for pharma and life sciences.
Regulation as Strategy
What makes Europe unique is not qubit counts but regulation as market infrastructure. For quantum healthcare, three frameworks matter most:
GDPR: mandates privacy and security by design, critical for sensitive genomic and clinical data.
Medical Device Regulation (MDR) & In Vitro Diagnostic Regulation (IVDR): quantum-enabled diagnostics must clear the same CE-marking hurdles as any AI-driven device.
AI Act: classifies healthcare AI (quantum or not) as “high-risk,” requiring transparency, bias monitoring, and human oversight.
For founders, this is not just a compliance burden but a potential export advantage: build under Europe’s strict rules, and your product is more likely to pass scrutiny in the US, UK, and Asia.
The Funding Landscape
European investors are cautiously optimistic. Quantum is a long game, but public–private models are de-risking the early stage. The European Investment Bank (EIB) has begun backing quantum startups, and national governments (e.g. France’s €1.8bn quantum plan) provide direct subsidies.
Still, private VC funding in Europe lags the US. The opportunity lies in co-investment: pairing deep-tech VCs with public grants to build resilient ventures that can survive the long runway to commercial ROI.
Strategic Takeaway
For Europe’s medtech and pharma founders:
Embrace regulation early: treat MDR, GDPR, and the AI Act as design inputs, not afterthoughts.
Leverage co-funding: combine EU and national grants with private capital to extend runway.
Anchor in hubs: partner with HPC centres, Fraunhofer, or national quantum labs to gain credibility.
Quantum healthcare in Europe won’t be won by the first to 1,000 qubits. It will be won by the first to regulation-ready, market-accessible solutions that can scale across 27 member states and then export globally.
