Tag: Digital Health

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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.

Categories
Digital Health MedTech

Poland’s healthtech has outgrown ‘nearshore’: 10 products and 10 global hubs

A network of interconnected digital health hubs in Poland, showcasing advanced healthtech and pharma IT innovations with professionals collaborating in futuristic environments.

Stop calling Poland a nearshore

Poland isn’t just shipping code for someone else’s roadmap. It’s producing digital health products used by tens of millions, and it’s hosting serious pharma/biotech tech operations—not just shared services. If you still think of it as a low‑cost back office, you’re reading a 2015 brochure.

Poland healthtech at a glance

MetricSnapshotSource
Healthcare marketPLN 191bn (~$52bn) (2023); projected 8.3% CAGR (2023–2028)Strategy& 2024
Medtech market (CEE)$11bn, largest in CEE; projected $13.8bnPAIH MedTech
Digital railsIKP, e‑Prescription (mandatory since 8 Jan 2020), e‑Referral (mandatory 2021)CeZ, e‑Rx analysis, policy
Enterprise hubs10+ pharma/medtech hubs (Roche, GSK, Bayer, Moderna, Astellas, BI, GEHC, Philips, Fresenius, AZ)Examples and links below

Polish products to watch (scale & potential)

CompanyWhat it doesScale / tractionMarkets & notes
DocplannerMarketplace + SaaS for clinics80m patients/month, 260k active doctors, 22m bookings/mo, 13 countriesEntered DACH via jameda acquisition
InfermedicaAI symptom‑to‑triage & intake86% user satisfaction; 76% intent to follow guidanceUsed by payers incl. Techniker Krankenkasse
DiagnostykaDiagnostics network1,100+ collection points, 156 labs; PLN 1.6bn revenue (2023); IPO priced at PLN 105; debut 7 Feb 2025Reuters
LabplusAutomated lab‑result interpretationIntegrated with leading labs incl. Diagnostyka partnershipB2B/API model across lab networks
CardiomaticsAI for Holter/long‑term ECGCE‑marked; clinician time savings reportedStudy overview
StethoMeAI‑enabled home stethoscopeCE‑marked lung‑sound analysis; remote respiratory careDeployed in telehealth programmes
AioCareConnected spirometryValidated in primary carePubMed
Saventic HealthAI for rare‑disease detectionEU roll‑out; €1.9m funding (2024)EU‑Startups
BrainScanAI for brain CT (stroke/trauma)2024 expansion across EMEAIndustry coverage
Jutro MedicalAI‑first hybrid primary care€12m Series A (2025) to expand EUEU‑Startups

Enterprise gravity: big pharma/medtech tech now runs through Poland

CompanyCityWhat happens hereScale (where stated)Source
RocheWarsaw & PoznańGlobal IT Solution Centre; Regional Clinical Trials Centre; Global Procurement Hub1,250+ employees in PolandRoche Poland
GSKWarsaw & PoznańGlobal Regulatory Centre; global trials coordination; Tech/Cyber600+ employeesGSK Poland footprint 2024
BayerWarsawDigital Hub building data platforms & productsup to 400 IT roles plannedAnnouncement, Hub page
ModernaWarsawInternational Business Services (finance, PV, HR, digital)~160 roles targetPress release
AstellasWarsawGlobal Capability Centre (2025)New hubLeadership news
Boehringer IngelheimWrocławGlobal Business Services centreLaunched 2022GBS page
GE HealthCareKrakówCommand Center software developmentPlatform in 290+ hospitalsGEHC Command Center
PhilipsŁódźGlobal Business Services hubOne of 7 global hubsPhilips GBS
Fresenius (FDT & FMC)WrocławDigital Technology & GBS hub for EMEAScaling teamsFresenius DT Poland,
AstraZenecaWarsawGlobal Clinical Trials CentrePart of AZ’s global networkAZ Poland

Why Poland now (and why it matters for commercialisation)

  • Public digital rails are in place. e‑Prescription has been mandatory since 8 January 2020; e‑Referrals became mandatory in 2021. The national P1 platform under Centrum e‑Zdrowia (CeZ) powers services like IKP/mojeIKP across the system.
  • Talent density × EU proximity. A deep engineering pool with multinationals co‑locating product and data teams in Warsaw/Poznań lowers integration costs across EMEA.
  • Export DNA. Docplanner’s acquisition of jameda shows a practical route: build in Poland, expand via M&A into regulated EU markets to accelerate trust and supply‑side liquidity.

Quick Q&A: for operators and investors

Is Poland still just a ‘nearshore’ play? No. Platform leaders (Docplanner, Infermedica) and 10+ pharma/medtech hubs now concentrate product‑adjacent work in Poland: engineering, data, regulator not only SSC/BPO.

What’s the biggest commercial bottleneck domestically? Limited, inconsistent NFZ pathways for digital health; most early revenue is private pay or export. Limited purchasing power within market. Treat Poland as an R&D and proof‑of‑value market; monetise in DACH/UK.

Best route to scale across Europe? Build MDR‑ready from day one, localise for DE/IT/ES, and consider controlled M&A to enter regulated markets (see Docplanner → jameda).

What metrics matter? Adoption proxies (e.g., Infermedica’s satisfaction and intent to follow guidance), conversion to appropriate care, reduced waiting time, and clinician time saved.

Playbook for founders and operators

  • Build for export from day one. Multilingual, MDR‑ready, and priced for DACH/UK.
  • Piggyback on the hubs. Partner with Roche/GSK/Bayer/Moderna teams locally for pilots, data pipelines, or co‑dev—your buyer is often already in Warsaw.
  • Measure what matters. Track adherence, conversion to appropriate care, and time‑to‑diagnosis—Infermedica’s adoption proxies are a good template (2024 data).

Bottom line

Poland isn’t Europe’s healthtech subcontractor anymore. It’s a product‑making, enterprise‑integrated node.
The smart money will treat Warsaw and Poznań as launchpads, not low‑cost destinations.

This content has been enhanced with GenAI tools.

Categories
Digital Health MedTech

Europe MedTech & Digital Health Weekly Brief #1

(Week of Aug 2–8, 2025)

August might be peak out-of-office, but Europe’s medtech builders didn’t pack it in. Cardiology AI is scaling, workflow AI is cutting admin drag, and evidence-backed devices are crossing borders.

People

    Marta Gaia Zanchi, Founding Partner at Nina Capital, Source: Nina Capital

    Investor POV:
    Marta Gaia Zanchi, Founding Partner at Nina Capital, speaking on healthtech hype vs. reality—data moats, regulatory timing, and evidence as currency shaping founder and LP conversations.

    Money flows

      Ross Upton, Ultromics Founder and CEO. Source: Ultromics.com

      Ultromics raised  $55M for AI cardiology diagnostics — Oxford-based echocardiography AI scaling decision support for earlier detection and heart failure insights across NHS/EU care.
      Listen to this interview with Ultromics Founder and CEO Ross Upton.

      SNIPR Biome logo. Source: SNIPRBiome website.

      SNIPR Biome gets €35M injection to advance CRISPR therapies for antimicrobial resistance. In this round there are new backers such as the Cystic Fibrosis Foundation and the German Federal Agency for Breakthrough Innovation (SPRIN-D)


      Oliver Åstrand, CTO; Oscar Boldt-Christmas, CCO; Lukas Saari, CEO; Founders of Tandem Health. Source: www.tandemhealth.ai

      Tandem Health secures $50M to build an AI-native operating system for clinical workflows across Europe.

      On the press

        One thing to remember

        In 2025 Europe, the fastest route from “cool demo” to “signed contract” is evidence-backed AI or devices that save clinician time and improve outcomes.

        Founders: design for clinical workflows, not just pilots; document outcomes and time-saved like it’s your superpower; pair dilutive with non-dilutive where it speeds trials and procurement.

        Investors: back teams converting regulatory readiness and real-world evidence into purchase orders—and keep an eye on AI companions where engagement meets adherence. Europe’s healthtech summer is quiet but compounding.

        This content has been enhanced with GenAI tools.

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        Digital Health MedTech

        Why SaMD Launches Fail in Europe

        Common Pitfalls

        1. Vague intended use leading to misclassification
        2. No QMS or weak cybersecurity
        3. Poor clinical evidence strategy
        4. Failure to engage clinicians or users

        Fixes:

        • Start regulatory early
        • Build real clinical value
        • Design with adoption in mind

        Learn more at Scaling MedTech: From Product to Market

        This post is part of SaMD Europe Launch Guide.

        This content has been enhanced by GenAI tools.

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        Digital Health MedTech

        Investment Trends in European Digital Health

        Where Capital Flows

        Investors favor:

        • AI-powered platforms
        • Value-based care tools
        • Female health (menopause, hormones)

        Valuation Benchmarks:

        • 4–6x revenue for most healthtech
        • 6–8x for AI/diagnostics
        • 10–14x EV/EBITDA for EBITDA-positive firms

        Learn more at Scaling MedTech: From Product to Market

        This post is part of SaMD Europe Launch Guide.

        This content has been enhanced by GenAI tools.

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        Digital Health MedTech

        Post-Market Surveillance for SaMD

        Staying Compliant Post-Launch

        Post-market surveillance (PMS) is required for all devices.

        Requirements:

        • Plan for data collection
        • Trend analysis and signal detection
        • Regular updates to clinical files
        • Vigilance reporting (e.g. EUDAMED)

        For Class IIa+, submit PSUR every 1–2 years.

        This post is part of SaMD Europe Launch Guide.

        This content has been enhanced by GenAI tools.

        Categories
        Digital Health MedTech

        SaMD Market Access & Reimbursement in Europe

        CE Mark ≠ Reimbursement

        Each EU country has its own reimbursement process.

        Highlights:

        – Germany (DiGA): Fast track, 12-month provisional access

        – France: Multiple programs (ETAPES, PECAN)

        – UK: NICE approval + local commissioning (ICBs)

        Evidence needs differ, it can be Randomized Controlled Trials (RCTs) or real-world evidence depending on system.

        Learn more on Scaling MedTech: From Product to Market

        This post is part of SaMD Europe Launch Guide.

        This content has been enhanced by GenAI tools.

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        Digital Health MedTech

        Clinical Evidence for SaMD in the EU

        MDR Requirements

        SaMD must show:

        • Clinical association (medical logic)
        • Analytical validity (correct processing)
        • Clinical validation (real-world benefit)

        Documentation:

        1. Clinical Evaluation Plan (CEP) = how you’ll gather evidence
        2. Clinical Evaluation Report (CER) = full evaluation
        3. Post-Market Clinical Follow-up (PMCF) = follow-up after launch

        Use real-world evidence, literature, or clinical studies.

        This post is part of SaMD Europe Launch Guide.

        This content has been enhanced by GenAI tools.

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        Digital Health MedTech

        The CE Marking Process for SaMD

        Get CE Mark

        Most SaMD is Class IIa or higher—requiring Notified Body involvement.

        Key Steps:

        1. Prepare tech documentation (Annex II, III)
        2. Implement QMS (ISO 13485)
        3. Create clinical evaluation plan (CEP) and report (CER)
        4. Work with a Notified Body

        Class-specific routes:

        • Class I: self-certify
        • Class IIa-III: Notified Body review + ongoing surveillance

        This post is part of SaMD Europe Launch Guide.

        This content has been enhanced by GenAI tools.

        Categories
        Digital Health MedTech

        SaMD Cybersecurity and GDPR

        Security = Safety

        Under EU MDR, cybersecurity is a General Safety and Performance Requirement. Failure to secure software is a patient safety risk.

        Technical Steps:

        • Secure architecture and testing (MDCG 2019-16)
        • Access control, encryption, logging
        • Vulnerability management and patches

        GDPR Considerations:

        • Health data = special category
        • Explicit consent and purpose limitation
        • DPIA (Data Protection Impact Assessment) required if high-risk AI involved

        This post is part of SaMD Europe Launch Guide.

        This content has been enhanced by GenAI tools.