Categories
Digital Health MedTech

Europe MedTech & Digital Health Weekly Brief (Week of Jan 19–26, 2026, #21)

A heavyweight week for the “reimbursement-first” era: chronic care platforms are hitting mega-round scale, NICE is formalizing the digital MSK pathway, and a French-made mitral valve just secured its ticket to the EU market.

People on the move

ONWARD Medical / Ali Kiboro
The Dutch-Swiss neurotech leader has appointed Ali Kiboro (ex-AliveDx, Quest Diagnostics) as CFO to steer the commercialization of its spinal cord stimulation systems.

BVI Medical / Jim Hollingshead
The former Insulet CEO takes the helm at the ophthalmology specialist as it deploys a $1B financing package to scale its global eye care portfolio.

mOm Incubators / Daniel Green
The portable neonatal tech startup named Daniel Green (ex-Caristo, Perspectum) as COO to lead the operational scale-up of its Dyson Award-winning incubators.

Money flows

Oviva
€200M ($217M), Series D, AI-enabled Chronic Care;
Led by Kinnevik (investing $100M) with participation from Planet First Partners and Norrsken VC. The funding scales its reimbursed digital programs for obesity, hypertension, and T2D across DACH and the UK.

Ananda Impact Ventures €73M, First Close, Health/Deeptech;
Backed by the EIF and NRW.BANK, this fifth Core Impact Fund targets later-seed and Series A healthtech startups across Europe.

Cancilico
€2.5M, Seed, AI Oncology; The Dresden-based spin-off is building automated hematology diagnostics (MyeloAID) to address the global shortage of pathologists.

On the press

  • HighLife SAS
    The Paris-based firm secured CE Mark for its Transcatheter Mitral Valve Replacement (TMVR) system, the first transfemoral, “one-size-fits-most” option for mitral regurgitation in Europe.
  • NICE Early Value Assessment (EVA)
    The UK body green-lit 8 digital technologies (including Hinge Health and Joint Academy) for NHS use in managing hip and knee osteoarthritis, provided they undergo 3 years of real-world evidence generation.
  • Abbott / TactiFlex Duo
    Won CE Mark for the world’s first dual-energy ablation catheter, allowing physicians to switch between pulsed field (PFA) and radiofrequency (RF) energy during a single AFib procedure.

One thing to remember

Evidence-backed, reimbursed digital care is moving from “pilot” to “platform.” The simultaneous arrival of a €200M round for payer-integrated care (Oviva) and NICE’s formal pathway for MSK apps signals that the “app” era is over, now it is the “clinical utility and evidence”.

Categories
Uncategorized

Europe MedTech & Digital Health Weekly Brief (Week of Jan 12–18, 2026, #20)

Quiet but productive: seed checks for prevention and preclinical tools, one neat CE mark, and a fresh EU call.

People on the move

Qureight / Rebecca Simmons
Ex-Riverlane operator becomes COO to scale the Cambridge clinical-trial imaging platform. [Source]

NanoSyrinx / Thomas Farrell
The UK-based intracellular drug delivery innovator appointed Thomas Farrell as CEO to steer its nanosyringe platform from concept to clinic; founder Joe Healey transitions to CSO. [Source]

BICO / Ewa Linsäter
The Swedish bio-convergence giant (formerly Cellink) tapped Ewa Linsäter as its new CFO to stabilize financial strategy following a period of aggressive M&A. [Source]

Money flows

ShanX Medtech
€24M package (equity, Innovatiekrediet, and €8.85M EC contract by DG HERA and HaDEA) to accelerate validation and EU launch of ultra-rapid infection diagnostics.

Ahead Health
$6M Seed, preventive “AI-native” health system; funds expansion across Europe and product development.

FluoSphera
€1.23M Seed. Geneva startup scaling an animal-free multi-tissue preclinical platform to speed drug discovery; backing from Soulmates Ventures and others.

On the press

FDA & EMA issue joint AI guidance
Regulators on both sides of the Atlantic published a “10 Principles” document for AI in medicine, creating a rare unified framework for lifecycle management and GxP compliance, a massive win for startups tired of dual documentation.

Boston Scientific scores CE Mark for Embold
The medtech giant received European certification for its Embold detachable coil system, expanding its neurovascular portfolio for treating stroke and aneurysms in EU centers.

Innovative Health Initiative (IHI) Call 12
The EU’s IHI partnership launched its single-stage Call 12, offering applicant-driven funding (50% public match) for consortia tackling unmet clinical needs—a prime target for startups seeking non-dilutive runway.

ACCESS-AD consortium
Amsterdam- and London-led public-private effort kicks off to accelerate Alzheimer’s diagnosis and treatment pathways in European health systems.

One thing to remember

With the new FDA-EMA joint AI guidance, “regulatory harmonization” is finally more than just a buzzword. Smart founders will use these 10 principles to build a single validation dataset that satisfies both watchdogs simultaneously, potentially shaving 12–18 months off their global commercial roadmap

Categories
Uncategorized

Europe MedTech & Digital Health Weekly Brief (Week of Dec 6–12, 2025, #18)

Deal flow picked up: cardiology workflow hardware gets a seasoned chair, obesity tech hits a pivotal milestone, and Europe leans into AI—from a €10m cross-border programme to NICE nudging digital MSK tools forward.

People on the move

CathVision (Denmark): Eric Thepaut (ex-Boston Scientific EMEA) becomes independent chairman; company also ships ECGenius v3.5 to tighten EP lab workflows.

Money Flows

• New funds that will touch healthtech: University2Ventures (U2V) closes first tranche of a €60M fund for European university spin-outs; KBC launches a €100M Start it Fund for Belgian startups from idea to IPO.

Xeltis (NL/CH): €40.3M equity + €9.7M debt (convertible loan + venture debt); to scale restorative cardiovascular implants and advance clinical programs.

FICUS Health (DE): €3M Seed; AI documentation automation for rehabilitation clinics to cut admin time and integrate with German data standards.

Punto Health (UK/ES): $2.7M Seed; building a speech-AI “OS for dementia care,” with pilots across NHS and Spanish centres.

ONEHEALTH (NI/ROI): €10M cross-border programme backed by PEACEPLUS to support AI/digital health projects and SME pilots over four years.

On the press

• NICE moves digital MSK forward — Early Value Assessment for digital tools managing mild-to-moderate hip/knee osteoarthritis reached “Resolution,” with publication due Jan 22, 2026. Signal to SaMD teams: evidence + value proposition now.

Nitinotes (IL/EU) hits pivotal first-patient milestone for EndoZip automated ESG; follows recent CE Mark enabling EU launch. Good read on automation entering bariatric endoscopy.

One thing to remember

The week says “AI with outcomes”: capital is flowing to workflow AI and documentation relief while public funding and NICE processes create room for evidence-led digital rollouts—set your 2026 plan to pair clinical claims with operational ROI and real-world pilots across EU/UK sites.

Categories
Digital Health MedTech

Europe MedTech & Digital Health Weekly Brief (Week of Nov 29–Dec 5, 2025, #17)

A compact week: venture debt fuels vascular access, cardiology gets a non-invasive CE mark, and NICE nudges digital rehab platforms toward the NHS.

People on the move

Lucile Blaise joins LivaNova (UK) as Global Head of Commercialization, Obstructive Sleep Apnea, adding strong EU market access chops to the executive team.

Money flows

Xeltis (NL) gets nearly €50M, venture debt + equity; package includes up to €37.5M from EIB (first €10M drawn) and €10M from existing investors EQT Life Sciences and Invest-NL. Funds push aXess vascular access conduit toward EU commercialization.

Angelini Ventures (Italy): €150M EIB co-investment agreement to back European biotech and digital health startups over six years (EIB €75M + Angelini Ventures €75M). Signals more institutional firepower for EU healthtech.

Annette (France) €2M round to scale its GLP-1 companion care platform for structured obesity support; led by Redstone, Ring Capital and AFI Ventures.

Ray Studios (France) €10M to expand its physician-led tattoo-removal clinic network across Europe; co-led by Factory Capital and Nickleby Capital.

On the press

Cardiawave (FR): Valvosoft® receives CE Mark as the first non-invasive ultrasound therapy for severe symptomatic aortic stenosis; data cited from EU FIM and pivotal studies across 12 centres.

• Boston Scientific: European approval for the Farapoint™ pulsed-field ablation focal catheter to treat atrial fibrillation, complementing Farapulse™ PFA platform.

• NICE (UK) publishes Early Value Assessment (HTE35) for digital platforms supporting cardiac rehabilitation, enabling conditional NHS use while evidence is generated over three years.

One thing to remember

EU cardiology is having a moment: capital is flowing into commercialization-ready devices, while regulators opened the door to earlier adoption of digital rehab and cleared a novel non-invasive therapy. Founders who can pair strong clinical data with payer-relevant outcomes will find both financing and fast-track pathways this winter.

Categories
Digital Health

Preventive diagnostics meets subscription-living: lessons from the US and Europe

The paradigm in healthcare is shifting: instead of “see a doctor when things go wrong”, some start-ups are betting the future lies in “continuous health monitoring for when things haven’t yet gone wrong”. The US model is blazing ahead; Europe is watching with interest and caution.

The US playbook: Function Health


Here’s the rundown for Function Health (Function) in the U.S.:

Strong traction and funding: A beta release in April 2023 reportedly hit ~50,000 paying members and >200,000 on the waitlist. They also closed a Series A backed by top-tier investors including Andreessen Horowitz.

Founded in 2021 (co-founded by Mark Hyman among others) to deliver a membership-based platform offering 100+ biomarker blood tests (and more) twice a year.

Members book tests at lab partners (over 2,000 locations via a partnership with Quest Diagnostics) and then receive reviews and insights from clinicians.

The promise: shift from reactive healthcare (“you’re sick, so treat”) to proactive (“monitor biomarkers, spot trends, intervene earlier”). As described by Function: “Health is not one test — it’s a pattern.”

Why this matters commercially

  • The business model: subscription + diagnostics + insights. Recurring revenue, high-engagement, measurable service.
  • The branding is consumer-centric: not “see a doctor”, but “stay ahead of trouble”.
  • From a marketing/omnichannel viewpoint: digital sign-up, lab booking network, data dashboards, membership renewal incentives.
  • The value proposition: for individuals willing to pay out-of-pocket, it aligns with performance, longevity, optimisation.

But there are caveats

  • The price point (~US$499/year for the basic membership) presumes consumers will pay for diagnostics out-of-pocket, outside insurance.
  • Some critics point out the risk of over-testing, consumer confusion, and “actionability” being less clear than the marketing suggests.
  • The model thrives in a U.S. environment: high out-of-pocket health spending, fragmented insurance, willingness to pay for wellness. Europe is different.

Europe: Similar plays, but different context

Enter Lucis, a Paris-based start-up positioning itself as “Function Health for Europe”.

Key points:

  • Lucis offers comprehensive blood testing plus AI-driven insights and personalised recommendations.
  • They claim to have achieved ~$400k ARR in Paris within four months, partnered with major lab networks in France, and are expanding to multiple European countries.
  • Their value chain: partner labs (for analytical quality), encrypted GDPR-compliant data, medical team review, actionable results.

Why this is noteworthy for European commercialisation

  • Reflects an appetite for preventive diagnostics beyond wearable devices and wellness buzz.
  • Shows that the membership/diagnostics model is crossing the Atlantic, albeit still early stage.
  • From a marketing perspective: branding preventive health not as gadgetry but as meaningful medical-lifestyle hybrid.

But Europe presents structural challenges

  • Many European health systems emphasise universal/public coverage; consumer willingness to pay direct for diagnostics may be lower.
  • Regulatory hurdles: Diagnostic tests often fall under stricter oversight; membership claims around trending biomarkers may invite scrutiny.
  • Distribution and reimbursement: Selling B2C across countries demands localisation (language, regulatory, lab accreditation) and often B2B or employer channels may be more realistic.
  • Value proposition needs to show ROI (cost savings, health outcomes) not just “optimisation” for affluent consumers.

Strategic takeaway for life-sciences / omnichannel marketing professionals

If you work in life-sciences commercialisation and are exploring preventive diagnostics or “functional health” (health optimisation, wellness-medical hybrid), here’s a sharper lens:

  1. Model to study: The Function Health structure (subscription + diagnostics + insights) is a template.
    • Digital marketing to attract consumers or employer channels.
    • Branding: lifestyle upgrade + health assurance.
    • Retention & renewal: what keeps users engaged year-to-year? Reports, re-tests, community.
    • Data & insights: dashboards, trends, clinician hooks.
  2. Europa adaptation is non-trivial: You cannot simply port the U.S. model wholesale. You’ll need to tailor for the European ecosystem:
    • Consider employer-benefit or private-insurance rebates rather than pure B2C in some markets.
    • Emphasise medically-grounded value: “preventive health saving cost/days lost” over “luxury optimisation”.
    • Ensure regulatory compliance across EU/EEA: IVDR, data privacy (GDPR), clinical claims.
    • Channel mix: digital acquisition + partnerships with labs, hospitals, insurers.
  3. Messaging & omnichannel tactics:
    • Use insight-led marketing: “discover 100+ biomarkers, track your health year-over-year” (audience: early adopters).
    • Leverage thought leadership (webinars, clinician commentary, open data).
    • Build recurring engagement: re-testing campaigns, personalised recommendations, lifestyle coaching add-ons.
    • Localise content for markets: language, healthcare system context, pricing comparisons.
  4. Risk management and credibility:
    • Avoid hype: emphasise what the data can show and what it can’t. Some markers don’t yet have actionable evidence.
    • Set realistic expectations: diagnostics without follow-through (behaviour change, medical supervision) may be less valuable.
    • Be prepared for regulatory push-back or scrutiny on claims of “prevention” vs “diagnosis”.

One thing to remember

Subscription diagnostics may be the future’s front door to preventive health, but only those who adapt for Europe’s market dynamics, regulatory terrain and consumer mindset will turn the key.

Categories
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.

Categories
Digital Health MedTech

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

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

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.

Categories
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.

Categories
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.