Tag: medical devices

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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

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.

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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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MedTech

Quantum & Supercomputers: How Hybrid Computing Could Shave Decades off MedTech R&D

Quantum and Supercomputers hybrid in MedTech R&D

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.

This content has been enhanced with GenAI.

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Digital Health MedTech

Quantum Healthcare in Europe: Funding, Regulation and the Path to Market

Quantum Healthcare in Europe - Funding, Reugulations and Path to Market

Europe’s Quantum Moment

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.
  • Germany: Fraunhofer institutes leading applied research and partnerships with IBM.
  • 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.

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Digital Health MedTech

Harvest Now, Decrypt Later: Why Healthcare Must Go Post-Quantum Today

Harvest now, Decrypt later - post-quantum healthcare - medtech security

The Threat

Healthcare runs on trust — but its digital backbone is fragile. A sufficiently powerful quantum computer will run Shor’s algorithm, breaking RSA and elliptic curve cryptography. That means everything from EHRs to connected pacemakers is at risk.

And the danger isn’t hypothetical. Adversaries are already engaging in “Harvest Now, Decrypt Later” (HNDL) — collecting encrypted medical data today to crack open once quantum machines catch up. Health records are especially valuable because they must remain confidential for decades, often a century.

The Urgency

The US NIST finalised the first post-quantum cryptography (PQC) standards in 2024, including CRYSTALS-Kyber for key establishment and CRYSTALS-Dilithium for signatures. The EU has yet to mandate PQC explicitly, but under GDPR’s requirement for “appropriate technical measures”, regulators will likely interpret compliance as requiring migration.

Medtech and pharma firms cannot afford to wait. Migration is not a patch but a multi-year transformation: inventorying cryptographic assets, building crypto-agile architectures, and upgrading every system from EHRs to clinical trial platforms.

The European Edge

Europe is not passive. The EuroQCI initiative aims to build a pan-European quantum communication infrastructure based on quantum key distribution (QKD) — an ultra-secure backbone for critical sectors, healthcare included.

But PQC migration remains the urgent first step. Quantum-secure comms infrastructure is years away; vulnerable encryption is a present reality.

Strategic Takeaway

For European healthcare organisations:

  • Start the migration now: waiting until Y2Q is too late.
  • Prioritise PQC vendors and services: the “picks and shovels” of the quantum security gold rush.
  • Engage boards early: GDPR fines (4% of global turnover) make PQC a board-level risk.

Quantum computing’s promise in drug discovery may take a decade. Its threat to healthcare cybersecurity is here today. The winners will be those who treat post-quantum cryptography not as R&D, but as critical infrastructure.

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Digital Health MedTech

Europe MedTech & Digital Health Weekly Brief (Week of August 30–September 5, 2025, #5)

Hospitals want evidence, investors want traction: this week mixed the two: GI diagnostics, insulin delivery, genomics M&A. And sprinkled in fresh CE marks for surgical robots.

People on the move

Data4Life (DE), a digital health nonprofit backed by SAP founder, Hasso Plattner, appoints Dr. Ben Illigens as CEO to steer its health data and research initiatives. Data4Life is building open source platform Data2Evidence, which is based on the international OMOP data model.

“We are at a turning point where digital technologies are fundamentally transforming research and care. My goal is to strengthen Data4Life as a bridge between clinical research, technology, and practice,”
Dr. Ben Illigens.

Lottie (UK): George Hadjigeorgiou, cofounder of ZOE, a personalized nutrition health company, joins the board of Lottie as NED, signaling deeper crossover between consumer health and eldercare ops. Lottie is a UK’s marketplace for care homes and care services.

Money flows

Kaleido Insulin Pump visualisation - Source: https://hellokaleido.com/

ViCentra (NL) — $85M Series D; insulin patch pump maker (Kaleido) fuels next-gen device development and scale-up.  Round was led by new investor Innovation Industries, a leading European deeptech venture capital firm, with matching participation from existing investors Partners in Equity and Invest-NL, alongside continued support from EQT Life Sciences and Health Innovations.

Cyted Health (UK) — €37.5M Series B; GI molecular diagnostics to improve early detection and prevention of oesophageal cancer. Round aims to expand US commercialization while consolidating NHS footprint. Investment led by EQT Life Sciences, Advent Life Sciences and British Business Bank with continued support from existing investors Morningside and BGF.

EndoSign® by Cyted

ArcaScience (FR): $7M round led by The Moon Venture; AI “benefit–risk” intelligence platform for life-sciences R&D to clean, link and query messy evidence.

Aiomics (DE) — €2M pre-Seed; clinical-grade AI agents to reduce clinical documentation burden and improve care pathways.

M2Care (FR): €26M venture-studio raise from Bpifrance’s FTA2 fund to create/develop eight healthtech projects. Other investors in M2Care are Mérieux Développement (who actully created this incubator), Institut NAOS des Sciences de la Vie, Crédit Agricole Centre-Est. 

SeqOne (FR) aquired Congenica (UK), on undisclosed terms.
This merger creates a larger AI-powered genomics software group with strong UK presence.

On the press

One thing to remember

Evidence-first commercialisation is back: capital flowed to diagnostics and chronic-care delivery while robotics snagged CE marks. A cross-border genomics deal underlined that European buyers will pay for software that shortens time-to-impact. If you’re fundraising, pair outcomes data with a path to multi-market reimbursement; if you’re buying, look for software that accelerates clinical workflows, not just visibility.

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Digital Health MedTech

Europe MedTech & Digital Health — Weekly Brief (Week of August 23–29, 2025, #4)

OrganOx metra transport. Source: OrganOx website

This week’s highlights: a landmark UK medtech exit, a €403 million EU funding boost for AI-powered devices, and strategic momentum building across Europe for medtech commercialization. Otherwise it seems we are on annual leave.

People on the move

No newly reported high-level hires, board moves, or fund leadership changes in the European medtech/digital health sector this week.

Money flows

One thing to remember

Founders: now is the time to align innovation pipelines with EU priorities—combine clinical validation and AI integration with a clear path to strategic M&A to attract both Brussels funding and corporate buyers.

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