Tag: medical devices

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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.

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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MedTech

OrganOx’s $1.5B Exit and Europe’s €403M MedTech Push: A Blueprint for Start-Up Success

OrganOx metra transport. Source: OrganOx website

Forget IPO hype. Europe’s MedTech scene is quietly reinventing exit strategies. The recent blockbuster OrganOx deal shows that patient-growth capital and global acquirers, not public markets, may set the real pace for scaling life-saving innovation.

OrganOx’s $1.5B Exit: A MedTech Precedent in a Quiet Market

Oxford-based OrganOx, a university spin‑out, has secured one of the UK’s largest MedTech exits, a $1.5 billion acquisition by Terumo. The deal delivered a 10× return for BGF, one of the UK’s most active investors. OrganOx’s technology, automated liver perfusion, has already supported over 6,000 transplants worldwide. In layman terms, it allows fors fully automated, easy-to-use preservation of the donor organ in a functional state for up to 24 hours.

In a market where IPOs have gone quiet, this deal sets a new precedent: high-value, clinically proven MedTech start-ups don’t need to chase the volatility of public markets to deliver impact and returns.

Europe’s MedTech Funding Engine: A Public‑Private Lever

The European Commission has approved a €403 million funding IPCEI programme for MedTech SMEs, with a focus on digital health and AI-enabled devices. The package is expected to attract €826 million in private capital and create 800 jobs across Europe.

For startups, this funding represents more than a financial lifeline: it’s a validation that EU policy is actively supporting MedTech innovation and aiming to rebalance Europe’s lagging venture ecosystem.

What This Means for Start-ups? Beyond IPOs to Real Outcomes

  • Exit without IPO: OrganOx proves that acquisition can be just as transformative as a listing.
  • Policy-driven growth: Founders should align their pipelines with EU funding priorities to maximise non-dilutive leverage.
  • Execution over hype: Europe rewards clinical validation and scalable access models—not moonshot projections.

Startups should design strategies that are M&A ready while embedding pathways to tap into EU-backed scaling opportunities.

Implications for Strategy and Investors

  • For founders: Patient growth capital and regulatory navigation matter more than vanity valuations. Position your business for strategic buyers who can unlock global reach.
  • For investors: The OrganOx exit underscores the value of holding through scale. In a funding environment tilted towards policy-supported growth, long‑term bets on MedTech SMEs can deliver double‑digit returns.

Conclusion

OrganOx isn’t just a headline; it’s a guidepost. In Europe’s MedTech world, execution and ecosystem alignment outperform aspiration for the trading floor. The lesson? IPO dreams may dominate headlines, but the real exits are happening elsewhere.

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Digital Health MedTech

Europe MedTech & Digital Health — Weekly Brief (Week of Aug 16–22, 2025, #3)

AI meets approvals, mental health consolidates, and early-stage device builders get fuel — a tidy week for cardiology/ophthalmology AI, workflow rollouts, and surgical tools.

People on the move

CMR Surgical: Chris O’Hara joins as Commercial President & GM (U.S.) to drive Versius robot expansion following FDA authorization; signals Cambridge-based CMR’s acceleration of global go-to-market. Mr. O’Hara brings experience at Intuitive Surgical (a company that builds DaVinci that Versius robot is challenging) and Globus Medical (specialists in spine sugery devices), his appointment is a strategic bet from CMR Surgical.

Money flows

Nami Surgical (Glasgow, UK): $10M, Series A (opened); developing a mini ultrasonic scalpel for robotic surgery. Proceeds support product development and commercialization prep. Tech from Nami addresses a critical unmet need in the field. Ultrasonic scalpels, which use high-frequency vibrations to simultaneously cut tissue and cauterise blood vessels, are indispensable tools in modern minimally invasive surgery. What they have is 90% smaller than available competitors.

Mindler (Sweden) acquires ieso Digital Health UK on undisclosed terms; creates a cross-border digital mental health platform spanning Nordics & UK buyers (employers, insurers, public payers). As there is an urgent need to address crisis of mental health and lack of (human) specialists, platforms such us Mindler and ieso are indispensable.  Mindler is acquiring only ieso’s UK-based telecare services business, which is responsible for direct patient care delivery to the NHS. The parent company, ieso, will remain an independent entity pivoting to focus on the development and commercialisation of its evidence-based clinical AI platform, Velora, with an initial focus on the US market.

On the press

• ZEISS lands CE mark for CIRRUS PathFinder: integrated AI decision-support for OCT that flags abnormal macular B-scans and improves OCTA visualization; EU-ready software update/licence.

• Femasys secures UK MHRA approval for FemBloc: non-surgical, in-office permanent contraception; follows the company’s recent CE mark and advances European commercialization.

• Affidea x Skin Analytics: pan-European partnership to deploy Class III CE-marked AI dermatology (DERM – Deep Ensemble for the Recognition of Malignancy) across sites, starting in Romania and Lithuania with Greece next.

One thing to remember The EU’s AI-in-diagnostics momentum is real: new CE/MHRA greenlights (ZEISS, FemBloc) are pairing with deployment deals (Affidea × Skin Analytics), while funding still finds focused hardware/robotics and safety wearables (Nami Surgical, SIT). Founders: bring regulatory-grade proof and a crisp rollout plan.

This content has been enhanced with GenAI tools.

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Digital Health MedTech

Europe MedTech & Digital Health — Weekly Brief (Week of Aug 9–15, 2025, #2)

A crisp week: AI diagnostics raised, sports concussion wearables funded, a Dutch conversational-AI startup got scooped up, and the UK nudged its devices policy closer to home care.

People on the move

Jade Leung - a new UK Prime Minister AI Adviser. Source: Linkedin

Jade Leung has been appointed as the UK’s Prime Minister’s AI Adviser while continuing as CTO at the AI Safety Institute; expect ripple effects on health AI policy and procurement.

Tom Moore - President and CEO of Minze Health

Thomas Moore named President & CEO of Minze Health to scale digital urology diagnostics/therapeutics across EU and the US.

Money flows

Sports Impact Technologies (Ireland): €650K Pre-Seed for behind-the-ear concussion-detection wearable; beta with athletes kicks off in September, full launch targeted for 2026.

Better Medicine (Estonia): €1M Pre-Seed to expand CE-certified AI for kidney cancer detection, fund EU rollout and FDA-aligned pilots.

VentriJect (Denmark) — €1.7M (round type undisclosed) to scale its cardiorespiratory fitness monitoring device (SEISMOfit) and push commercialization.

HOPCo × Caro Health (the Netherlands) — Amsterdam’s conversational-AI health startup Caro Health acquired by US-based HOPCo; Caro’s team to expand HOPCo’s European digital division and integrate across products.

On the press

Automated insulin delivery — Utrecht’s ViCentra says its next-gen closed-loop Kaleido system is slated for a Europe launch next year, signaling more AID competition on the continent.

UK devices policy — MHRA opens a stakeholder survey on the Health Institution Exemption (HIE), floating extensions to community/home use and tighter PMS/governance—practical for hospital “in-house” SaMD/device teams.

Macro: Italy watch — New data show Italy’s tech funding momentum; healthtech has already raised ~$126M in 2025, underlining ongoing digital health demand.

One thing to remember

AI-heavy workflow tools are getting their first cheques (imaging, concussion safety) while cross-border consolidation (Caro→HOPCo) accelerates go-to-market—set against a UK policy tweak that could legitimize more hospital-built software/devices beyond the hospital walls. If you’re raising: show path to deployment (pilots, CE status) and a plan for integration into care pathways.


This content has been enhanced with GenAI tools.