Tag: MedTech Commercialization

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Digital Health MedTech

Europe MedTech & Digital Health Weekly Brief (Week of 11–17 October 2025, #10)

Workflow AI meets breast imaging and structural heart trials: a week of pragmatic progress across funding, CE marks, and sandboxed regulation.

People on the move

Avanzanite Pharma names Giovanni Galliano General Manager for Italy to accelerate rare disease launches and market access.

AVITA Medical Board Chair Cary Vance becomes Interim CEO as company recalibrates commercialization; preliminary Q3 revenue guidance included.

Money flows

Spex Capital (UK) — €30M first commitment toward a €100M Venture HealthTech Fund; targeting early-stage digital health/medtech globally with tickets up to €5M. Expect more UK/EU clinical commercialisation support via its NHS ties.

Gladys (UK) secured £1.5M seed for AI-enabled home care coordination; plans to scale across local authorities and domiciliary providers.

Meta-Flux (Ireland) €1.8M seed (techbio) to expand its AI “virtual biologist” for preclinical decision support; signals steady investor appetite for data platforms feeding medtech/diagnostics pipelines.

On the press

Vara (Germany) granted CE certificate for AI breast-imaging software, enabling EU deployment as an independent second reader and decision-support tool in screening/diagnostics.

MHRA (UK) — selects seven technologies for Phase 2 of the AI Airlock and publishes pilot report; a concrete pathway for AI-as-a-Medical-Device evidence generation in the NHS.

Anteris (USA) — receives first European regulatory clearance in Denmark to commence PARADIGM pivotal trial of the DurAVR transcatheter heart valve; Danish recruitment slated for Q4 2025.

One thing to remember


Even in a choppy macro, European medtech/digital health kept moving: targeted capital (Spex, Gladys), real approvals (Vara CE), and live regulatory pathways (MHRA Airlock) all point to a market rewarding evidence and workflow impact—build for deployment, not demos.

This content has been enhanced with GenAI.

Sources

https://tech.eu/2025/10/13/gladys-secures-1-5m-to-scale-ai-home-care-across-the-uk/
https://www.eu-startups.com/2025/10/british-healthtech-investor-spex-capital-announces-e30-million-commitment-to-e100-million-fund/
https://www.gov.uk/government/news/ai-tools-that-could-detect-diseases-earlier-selected-for-next-phase-of-mhras-ai-airlock-programme
https://www.auntminnieeurope.com/clinical-news/womens-imaging/news/15769386/vara-granted-ce-mark-for-ai-breast-imaging-software
https://www.gov.uk/government/publications/ai-airlock-sandbox-pilot-programme-report
https://www.businesswire.com/news/home/20251013986565/en/Avanzanite-Expands-Italian-Operations-with-General-Manager-Appointment

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Digital Health MedTech

ZEISS, Ocumeda, and the Optical Trojan Horse: Omnichannel in MedTech

Zeiss.com - Vision Care

The €100 Million Bet on Retail Diagnostics

Omnichannel in MedTech usually means a half-baked app, an email campaign, or a portal nobody uses. ZEISS changed the script.

In March 2025, ZEISS launched its EyeCare Network and quietly took a €10 million stake in Ocumeda, a tele-ophthalmology platform connecting 700 optical stores to 300,000 patients. Retail stores. Welcome to the new front line of diagnostics.

What’s Happening in Stores

The journey starts when someone walks into an optician’s shop to get new glasses. Instead, they’re offered a medical-grade eye check using ZEISS devices like the VISUREF 1000. That data is sent to a licensed ophthalmologist through Ocumeda’s secure platform. Within hours, the patient gets a validated medical opinion.

Wir sind ocumeda

This is more than a tech pilot:

  • 120,000+ screenings already done in Germany.
  • 700+ sites onboarded.
  • Rollout underway in Austria and Switzerland.

Retail is becoming the gateway to care. Not the follow-up. The entry point.

Why This Is True Omnichannel in MedTech

Most omnichannel talk is just marketing. ZEISS is building infrastructure.

  • Retail as healthcare touchpoint
  • Hardware + software + clinical validation
  • Training and support for store staff
  • GDPR-ready workflows from day one

Every part of the journey — from store to cloud to clinic — is tightly integrated.

Why ZEISS Bought a Piece of the Ocumeda Platform

ZEISS didn’t stop at integration. It bought 10% of Ocumeda, with the option to go to 25%. This isn’t a partnership but a vertical integration.

Owning a slice of the platform means:

  • More influence over features, pricing, data standards
  • Tighter alignment between devices and digital workflows
  • Protection from being locked out by third-party platforms

Think Apple with its chips. Tesla with batteries. ZEISS wants the same control in MedTech.

Where It Could Go Wrong

The model works. But scaling it won’t be easy. Risks include:

  • Channel tension – Will ophthalmologists feel replaced?
  • Quality variation – Can every optical shop maintain high standards?
  • Data governance – Who owns the patient data?
  • Regulatory fog – Is a retail “screening” still a medical act?
  • EU complexity – Rules change across borders. Fast.

The challenge isn’t the tech. It’s alignment on legal, operational, and clinical level.

For MedTech practitioners it has one more caveat. Vision Care has retail element while other areas such as Orthopedics, Specimen Management, Medication Management are pureplay B2B.

FAQs: What You Need to Know

Is this reimbursed care?

Not yet. It’s mostly out-of-pocket, but early signs show willingness to pay for convenience and speed.

Is ZEISS building a competitor to ophthalmology clinics?

No. It’s offering pre-screening. Final decisions still rest with licensed doctors.

Why is this different from telehealth apps?

Because it integrates physical diagnostics, real medical devices, and human oversight, not just video calls.

Could Zeiss Vision Care model scale to other specialities?

Any field with simple tests, decentralised screening potential, and device-led data capture could follow suit.

What Other MedTech Companies Should Learn

This isn’t about gadgets. It’s about building a system where:

  • Devices become data sources.
  • Stores become clinics.
  • Platforms become the product.

If you’re still pushing apps with no backend, portals with no users, and devices with no data strategy, you’re not doing omnichannel. You’re doing PR.

Final Takeaway

ZEISS is turning the optical shop into a diagnostic hub and buying into the data backbone that powers it. This is what real omnichannel looks like in MedTech, where the product is the experience, and the device is just the entry point.
Own the gateway. Or someone else will.

This content has been enhanced with GenAI.

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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

https://disrupting.healthcare/wp-content/uploads/2025/10/simple-life.mp4

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

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

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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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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