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Digital Health MedTech

Europe MedTech & Digital Health Weekly Brief – Funding, AI Act & Imaging (Week of Nov 22–28, 2025, #16)

Oncology operating systems, perioperative risk AI and pre-CT stroke triage all raised fresh capital this week, while Brussels and Munich quietly tightened the screws on AI compliance and imaging vendors celebrated a shiny new CE mark.

People on the move

Ergea Group (Luxembourg)
New CEO for pan-European imaging & cancer care

Ergéa, a Luxembourg-based pan-European provider of diagnostic imaging and cancer care services, has promoted David Rolfe from UK CEO to Group CEO and appointed Mark Graves as the new CEO of Ergéa UK, signalling a more integrated European growth push in imaging and radiotherapy infrastructure.

Restore Medical (Israel):
ex-Medtronic dealmaker takes the chair

Heart-failure device company Restore Medical (Israel, backed in part by the European Innovation Council Fund) has appointed Chris Cleary, former SVP Corporate Development at Medtronic and architect of the Covidien mega-deal, as chairman of the board to guide its transcatheter heart-failure therapy through advanced US and global clinical development.

Money flows

Gosta Labs (Finland)
€7.5M seed, oncology AI operating system
Helsinki-based Gosta Labs raised a €7.5 million seed round, led by Voima Ventures with COR Group, the Aho family, Reaktor and other angels, to scale its oncology-focused AI operating system that turns each patient encounter into structured data, slashes documentation time and links care decisions to international treatment guidelines. The company plans to deepen medical-device-grade development and expand deployments across Europe, the Baltics and Australia.

Noteless (Norway)
€3.5M to fight doctor burnout
Oslo-based Noteless, a Norwegian HealthTech startup automating clinical documentation and task management, closed a €3.5 million round to tackle physician burnout by cutting admin time in hospitals and clinics; the investor syndicate includes People Ventures and Alliance Venture, with the company targeting broader Nordic and European rollout.

Healthplus.ai (NL)
€2.3M late-seed for perioperative risk prediction AI
Amsterdam-based Healthplus.ai raised €2.3 million in a late-seed round led by Elevating Capital and co-led by LUMO Labs, with ROM InWest and Pathena among the participants, to expand PERISCOPE®, its ISO- and CE-certified AI system that predicts post-surgical infection risk and suggests mitigation strategies for surgical teams. The funding will support deeper EHR integrations (Epic, Cerner, ChipSoft), further model development across perioperative pathways and broader roll-out in Europe plus FDA clearance work for the US.

    AI-Stroke (France)
    $4.6M seed for pre-CT stroke triage
    Paris-area medtech AI-Stroke secured a US$4.6 million seed round led by Heka (Newfund VC) with Bpifrance and angels, to advance an “AI neurologist” that runs on smartphones or tablets for pre-hospital stroke triage, analysing 30-second video of facial symmetry, arm movement and speech. The capital will fund FDA regulatory work and multisite clinical studies in leading US stroke centres, with the company also adding a heavyweight international stroke advisory board.

    On the press

    TÜV SÜD launches voluntary EU AI Act conformity certificates

    TÜV SÜD announced new services for early, voluntary conformity certificates under the EU AI Act (Regulation (EU) 2024/1689), offering manufacturers of AI systems including high-risk use cases in medicine and medical devices an independent review of technical documentation and partial compliance ahead of mandatory assessments. The program covers gap assessments, training and an “Attestation of Conformity,” aimed at helping companies get AI products AI-Act-ready before notified bodies are fully designated.

    GE HealthCare wins CE mark for Omni 128 cm total-body PET/CT

    GE HealthCare received CE mark for its Omni 128 cm total-body PET/CT system, enabling commercialisation in the EU of an ultra-long axial field-of-view scanner intended to improve sensitivity, enable low-dose protocols and support advanced oncology and theranostics workflows. The platform is pitched at high-throughput cancer centres and research hubs across Europe.

    MHRA outlines “innovative approaches” to medtech regulatory reform

    The UK MHRA’s MedRegs blog set out its latest thinking on medtech regulatory reform, highlighting more agile statutory instruments, innovation-friendly approval routes, and closer alignment with international partners for medical devices and IVDs. For EU-facing companies selling into the UK, the piece is a useful signal on future reliance routes and how sandbox-style approaches may coexist with post-market vigilance expectations.

    One thing to remember

    AI-heavy clinical tools are still getting funded from oncology operating systems to perioperative risk prediction and pre-CT stroke triage. This week’s TÜV SÜD and MHRA moves are a clear reminder that in Europe, “AI-first” now has to mean “AI-and-compliance-first.”

    For founders, the competitive edge is shifting toward teams that can show device-grade evidence and be visibly AI-Act-ready long before their product hits a hospital PACS or EHR.

    This content has been enhanced with GenAI.

    Categories
    Digital Health MedTech

    2024 vs 2025: Where the Money’s Really Coming From in European HealthTech

    If you work in HealthTech in Europe, you’ve probably noticed something strange. 2024 felt like the world was ending, yet the actual numbers say something very different.
    Capital didn’t disappear — it simply stopped tolerating nonsense.

    Now, in 2025, the money is flowing again, and aggressively so.
    But it’s flowing selectively.

    2024: The Great Reality Filter

    Forget the headlines about a funding collapse. What actually happened in 2024 was a reset of expectations. Investors didn’t stop writing cheques, they just stopped writing them for half-baked pitch-deck poetry.

    A study analysing ~1,300 funding rounds across European biotech, medtech and digital health showed fewer deals, but bigger ones.
    Median pre-seed funding actually rose ~15.7% YoY to around €870K, which doesn’t sound like panic to me.

    And Q3 2024 alone brought nearly US$2B in HealthTech investment..
    The hubs were the usual suspects: UK, Germany, France, with Spain, Portugal and the Netherlands quietly moving up the table.

    The hottest segments?
    Oncology, biotech and AI-powered diagnostics: areas where outcomes are measurable and regulatory paths exist.

    Karista summed up the year perfectly: a “reality filter.

    It was not a crash, but a sorting mechanism.
    The pretenders left the room, the contenders stayed.

    2025: Capital Is Back, Smarter

    Then 2025 arrived and the mood changed fast.

    According to Galen Growth, European digital health funding grew 52% YoY in H1 2025, totalling around US$3.4B across 182 deals. Europe is representing 26% of global funding

    Figure 1. European Digital Health Funding Trend 2021–2025 (Indexed)
Indexed view using 2021 baseline of 100. 2025 funding growth (52% YoY, US$3.4B H1) based on Galen Growth. 2021–2024 values illustrative, derived from partial public snapshots.

    Figure 1. European Digital Health Funding Trend 2021–2025 (Indexed)
    Indexed view using 2021 baseline of 100. 2025 funding growth (52% YoY, US$3.4B H1) based on Galen Growth. 2021–2024 values illustrative, derived from partial public snapshots. Source: disrupting.healthcare

    And the average deal size jumped to roughly US$18.6M, nearly three-times the Q2 2024 level.

    Figure 2. Average Deal Size — 2024 vs 2025 (Relative)
    Based on publicly reported 3× YoY increase in average deal size (Galen Growth, Healthcare.Digital). Source: disrupting.healthcare

    Even more striking: ~65% of all capital went to AI-powered clinical and diagnostic platforms.

    Figure 3. Capital Allocation by Segment — H1 2025
    ~65% of capital allocated to AI-driven clinical & diagnostic platforms (Galen Growth, H1 2025). Source: disrupting.healthcare

    The investment ecosystem has expanded dramatically:
    254 active digital-health-focused funds in 2025 vs 84 in 2021.

    This isn’t a hype revival, but it’s conviction capital. Investors aren’t betting on stories. They’re betting on proof.

    The Difference in One Sentence

    2024 sorted the real players from the noise.
    2025 is paying the real players.

    Metric2024 2025
    Deal flowReduced volume Clear acceleration
    Average deal sizeReduced volume €16M
    Funding FocusBiotech, oncology, med-deviceAI-clinical & diagnostic
    Investor tolerance Traction required Validation required
    Entry barrier Brutal Still high, but capital available
    Capital geography UK, DE, FR Broader pan-EU activity

    What to Do With This Information

    If you’re a founder:

    • If you have validation: raise now.
    • If you only have a concept deck: don’t waste everyone’s time.
    • Mix non-dilutive + VC — it’s no longer optional.

    If you’re an investor:

    • Europe is still undervalued vs the US — genuine upside exists.
    • Secondary acquisitions are coming.
    • AI is not a theme — it’s now an allocation mechanism.

    It’s not 2021 again. 2025 is healthier, clearer, and honestly, more exciting.

    Data Methodology & Transparency

    The charts included in this article illustrate directional trends in European HealthTech funding rather than precise historical totals. Publicly available data does not provide continuous, fully aggregated funding records across all HealthTech sub-segments (digital health, medtech, diagnostics, biotech) from 2021 through 2024.

    2025 funding values, including YoY growth, deal count and sector capital allocation are based on publicly reported figures from Galen Growth (H1 2025): European Digital Health Bucks the Global Trend

    The indexed 2021–2025 funding trend chart is a normalized illustrative representation designed to highlight directional recovery and acceleration rather than exact historical volumes. Earlier periods (2021–2024) are estimated using partial public snapshots and normalized to a 2021 baseline of 100 to enable comparison.

    The chart communicates trajectory, not absolute values.
    Where precise historical figures are required (e.g. investor deck, financial report), a consolidated dataset should be constructed from Dealroom / PitchBook / CB Insights / Crunchbase Pro and national grant databases.

    Next in This Series

    Best Places to Launch or Scale a HealthTech Company in Europe

    Spoiler: it is definitely not always London or Berlin.

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    Digital Health MedTech

    Europe MedTech & Digital Health Weekly Brief (Week of Nov 15–21, 2025, #15)

    Robotics bags big money, IVF gets an automation CE mark, and UK regulators sketch next steps for AI in care.

    People on the move

    Distalmotion (Switzerland) Chas McKhann becomes Executive Chairman alongside a $150M raise; focus is US growth while keeping EU base in Lausanne.

    Money flows

    Distalmotion (Switzerland) $150M, Series G / growth; scaling DEXTER® surgical robotics with ASC push and US commercial build-out.

    Sofinnova Partners (France) — €650M, flagship Capital XI; early-stage focus in medtech/biopharma, active deployment underway.

    On the press

    • Overture Life (Spain) CE markfor DaVitri™, billed as the first automated device cleared in the EU or US for vitrifying unfertilised eggs; EU commercial rollout begins.

    Cardiovalve (Israel) CE file submitted for transcatheter tricuspid valve after positive TARGET study interim; EU approval process initiated.

    JenaValve (Germany) 1,000th case with CE-marked Trilogy™ TAVR for aortic regurgitation/stenosis, signalling steady EU adoption.

    • MHRA (UK): Professor Alastair Denniston outlines principles for “safe, fast and trusted” regulation of AI in healthcare; more detail expected in 2026.

    One thing to remember

    Capital and credibility still move together: big-ticket robotics funding and a heavyweight €650M early-stage fund arrived the same week that EU-relevant CE activity and the UK’s AI-in-health policy guardrails advanced. It is an evidence that clear regulatory paths plus deployment stories are what unlock cheques right now.

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    Europe MedTech & Digital Health Weekly Brief (Week of Nov 8–14, 2025, #14)

    A compact week: small but pointed rounds in diagnostics and patient safety, a urology partnership scaling across EMEA, radiosurgery planning cleared on both sides of the Atlantic, and a headline corporate restructure.

    People on the move

    Exstent (UK) – Vascular surgeon Matt Thompson becomes CEO to drive commercialization of patient-specific aortic support.


    Money flows

    Self.co, formerly known as Allergomedica, (Lithuania) a €2.56M mixed grant + venture to scale molecular allergy testing and expand into the UK, Ireland, Austria and Germany; grant component from Innovation Agency Lithuania.

    Enteral Access Technologies (UK) a £500K bridging round to scale DoubleCHEK, its CO₂+pH nasogastric tube placement safety device; building UK adoption and early EU rollout.

    Minze Health (Belgium) × Medtronic: a three-year EMEA partnership to offer Minze’s automated bladder diary (Diary Pod) to patients receiving Medtronic sacral neuromodulation therapy; strengthens digital urology care pathways.

    On the press


    ZAP Surgical: ZAP-Axon radiosurgery planning system receives both EU CE certification and US FDA 510(k); enables clinical use across the EU and US.

    Siemens to deconsolidate Healthineers: Siemens plans a direct spin-off of 30% of its ~67% stake to shareholders, cutting to ~37% and targeting <20% medium-term; expect governance/strategic autonomy effects for a core European medtech anchor.

    • Tele-robotics milestone: Sentante (Lithuania) reports a first-of-a-kind remote robotic stroke procedure in Scotland guided by specialists located in Florida and Dundee; early signal for cross-border neuro-intervention models.

    One thing to remember


    Seed-stage cash is trickling into practical, reimbursable workflows (diagnostics, patient safety) while scale comes from channel partnerships and regulatory wins; design for distribution and evidence now so you’re ready when the capital tides turn.

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    Digital Health MedTech

    Who’s Funding the Boom?

    The VCs, public funds, and CVCs writing cheques in European healthtech (2025 edition)

    Healthtech funding in Europe is accelerating again.
    After a cautious 2023, investment rebounded to $4.8 billion in 2024, and Q1 2025 alone brought in $4.3 billion. Healthtech now captures 30 to 35% of all venture activity across the continent. But who’s actually writing those cheques?

    This post breaks down the capital stack behind Europe’s digital health growth: venture capital, public funds, and corporate/strategic investors. Whether you’re raising or deploying capital, here’s who you need to know in 2025.

    1. Venture Capital: Still the Primary Engine

    Venture capital is behind most of the major healthtech rounds in Europe. From seed to Series C, VCs provide the scaling fuel, validation, and network access.

    Top 5 VCs Investing in European HealthTech:

    • Sofinnova Partners: Paris-based life sciences fund active in healthtech, diagnostics, and therapeutics.
    • Octopus Ventures: UK fund with a strong healthtech thesis, including femtech and digital care.
    • Speedinvest: Vienna-based early-stage investor with a focus on digital health and care platforms.
    • EQT Life Sciences: Nordic growth-stage investor in diagnostics, medtech, and health platforms.
    • Calm/Storm Ventures: Focused on pre-seed and seed-stage digital health across underserved areas like paediatrics and mental health.
    Who are the best VCs for digital health in Europe?

    Those five are consistently active in 2024-25, spanning early to growth-stage capital.

    2. Public & EU Funding: De-risking and Catalysing Growth

    Public funding rarely leads rounds, but often enables them. Grants, co-investments, and match funding are key to bridging early clinical stages and reimbursement pilots.

    Key Public Funding Sources for HealthTech in Europe:

    • Horizon Europe: EU R&D programme with dedicated tracks for health and medtech.
    • EU4Health: €5.3 billion programme for health system resilience and digitalisation.
    • European Investment Bank (EIB): Committed €70 billion (2025-27) to tech, including health innovation.
    • Bpifrance: France’s national investment bank, active in medtech, digital health, and AI.
    • Innovate UK: Grant and co-investment body supporting UK healthtech pilots and R&D.
    Can you get EU grants for a healthtech startup?

    Yes. Programmes like Horizon Europe, EIC Accelerator, and EU4Health fund clinical validation, digital health infrastructure, and medtech scale-up.

    3. Corporate Venture & Strategic Investors: Validation with Capital

    CVCs and strategic investors are increasingly active in Series B+ deals. They offer more than capital, including access to clinical settings, distribution, and potential M&A.

    Key Corporate Venture Funds:

    Do corporates invest in digital health startups in Europe?

    Yes. In 2025, CVCs from pharma, medtech, and insurance are increasingly co-investing in digital health.

    Estimated Funding Breakdown (2025):

    SourceShare EstimateRole
    Venture Capital / PE65–75%Lead rounds, scale capital
    Public Funds / Grants (EU + National)10–20%Early-stage, pilots, non-dilutive
    Corporate / Strategic / CVC10–15%Strategic fit, late-stage, distribution

    Insight: Most healthtech rounds in 2025 involve blended capital: a VC lead, public match-funding, and a strategic partner.

    Strategic Takeaways

    Founders: Match your capital to your stage. Grants and public co-investments work best pre-revenue or pre-regulatory.
    Investors: Watch for startups with public funding traction—often a good de-risking signal.
    Operators: CVCs are gatekeepers to reimbursement and go-to-market. Engage early, but be realistic on timing.

    Next up: How the funding mix changed between 2024 and 2025, and what it signals about the future of EU healthtech capital.

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    Digital Health MedTech

    Europe MedTech & Digital Health Weekly Brief (Week of Nov 1–7, 2025, #13)

    Cardio-adjacent robots, workflow expansions, and device commercialization: this week mixes a new fund backing medtech, a fresh CE mark, and EU market-surveillance tidings.

    People on the move

    DBV Technologies (Germany)
    Kevin Trapp becomes Chief Commercial Officer to prep European go-to-market.

    Money flows

    United Founders (Luxembourg)
    €80M early-stage fund, cheques up to €1M, targeting AI, hardware, dual-use and medtech; early health bet includes Germany’s Every Health. Expect more operator-led tickets into clinical workflows.

    Holi (Poland)
    €3M Seed; digital obesity clinic. New markets in EU on deck; product build around data-driven care pathway.

    Nanox (Israel) ↔ EXRAY (Czech Republic)
    Distribution partnership for Nanox.ARC 3D imaging across Czech Republic; leverages recent EU CE mark to widen footprint. Useful read-through for cost-sensitive imaging buyers in CEE.

    On the press

    Nitinotes (Israel) – CE mark for EndoZip, an automated suturing system for endoscopic sleeve gastroplasty; sets up EU commercialization of obesity intervention between drugs and surgery.

    • EU #MedSafetyWeek Commission’s health agency Hadea spotlights JAMS 2.0, the joint action strengthening medical device/IVD market surveillance, inspections and data exchange across Member States. Signal: more coordinated enforcement under MDR/IVDR.

    Urteste (Poland) launches European multicenter clinical study of Panuri, an oncology test; another CEE diagnostic attempting EU-wide validation.

    One thing to remember

    Obesity and imaging drove the week: fresh capital for a Polish digital clinic, a CE-marked automated ESG platform, and a Czech distribution deal show Europe’s buyers want scalable, cost-sensitive interventions. Pair commercialization sprints with the EU’s tighter market-surveillance push to avoid regulatory surprises later.

    This content has been enhanced by GenAI.

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    Digital Health MedTech

    Europe MedTech & Digital Health Weekly Brief (Week of Oct 25–31, 2025, #12)

    AI pathology and precision health get fresh fuel; MDR CE marks stack up; MHRA drops safety signals and an IDAP tweak—another week of pilot-to-product momentum.

    People on the move

    ViCentra (the Netherlands) Ex-Dexcom and Medtronic leaders join to scale Kaleido across Europe; Karen Baxter becomes SVP Sales, Europe; Jay Little becomes VP Strategy & Business Development.

    Earlybird Health (Germany) Dr. Rabab Nasrallah and Dr. Christoph Massner promoted to Partners, reinforcing the firm’s biotech/medtech/data focus.

    Money flows

    Primaa (FR)
    €7M round; AI histology/cancer diagnostics. Funds support EU deployment and U.S. expansion prep.

    Human Health (UK)
    €4.7M Seed; patient-first precision health platform and “Human Evidence” for B2B.

    MoleSense (Switzerland) — CHF 150k (€156k) Venture Kick grant; molecular maternity wearables for high-risk pregnancies.

    On the press

    Lumendi EU MDR CE mark for DiLumen™ EZ¹ and DiLumen™ C¹ endotherapy devices; enables EU commercial distribution.

    Bot Image MDR CE mark for ProstatID® AI prostate MRI software, opening European market access; product is FDA-cleared in the U.S.

    MHRA — October Safety Roundup and Field Safety Notices published; useful for vigilance teams.

    • MHRA — IDAP update: UCNA extension for HistoSonics’ EDISON™ ultrasound ablation system; worth tracking alongside EU MDR routes.

    One thing to remember

    Regulatory momentum matters: CE marks keep landing while the UK fine-tunes access pathways, and capital is returning tohiow focused clinical AI and women’s health sensors. Founders who tie clinical utility to crisp EU/UK access narratives will convert faster to distribution.

    This content has been enhanced with GenAI.

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    The Top 10 Most Valuable HealthTechCompanies in Europe (2025)

    Valuation isn’t everything but in healthtech, it tells you who’s still scaling

    Let’s not pretend valuation is the ultimate success metric. But it is a decent proxy for where capital, confidence and commercial traction are flowing. Especially in a market as fragmented and overregulated as European healthcare.

    The 2025 leaderboard of Europe’s top 10 most valuable healthtech companies.


    Not biotech. Not pharma. Just tech-enabled health. Companies at the intersection of software, care and medical delivery models. Most are private. A few are flying under the radar. And yes, Finland opens the list.

    1. Oura Health (Finland)

    Valuation: US$11 billion (Sep 2025)
    What it does: Smart wearable ring + health analytics
    Why it matters:
    Europe’s wearables play moving into serious health data.

    2. Doctolib (France)

    Valuation: US$6.4 billion (2025 ranking) 
    What it does: Appointment booking and telehealth platform for European health systems.
    Why it matters: A dominant platform reaching scale across French & German markets, signalling what digital
    health infrastructure looks like in the EU.

    3. Sword Health (Portugal)

    Valuation: US$4 billion (June 2025 funding round) 
    What it does: AI-enabled digital therapy / musculoskeletal care
    Why it matters: Bridges digital therapeutics and service delivery with high value healthcare cost savings.

     4. Kry International AB (Sweden)

    Valuation: Reported ~US$2 billion 
    What it does: Telemedicine/virtual primary care (marketed as “Livi” in UK/France)
    Why it matters: One of the larger pan-European virtual care plays.

    5. Cera Care (UK)

    Valuation: Reported >US$1 billion (source)
    What it does: Tech enabled home care & community services
    Why it matters: A service delivery business scaling across UK homecare, a difficult but high impact node of the health system.

    6. Flo Health (UK)

    Valuation: ~US$1 billion
    What it does: Women’s health (cycle tracking, fertility, health analytics)
    Why it matters: Rare consumer digital health “scale” platform in Europe with global ambitions.

    7. Neko Health (Sweden)

    Valuation: ~US$1.8 billion
    What it does: Full body scanning diagnostics with AI
    Why it matters: Diagnostics and proactive screening is one of the less hyped but high upside segments in EU healthtech.

     8. Cequr SA (Switzerland)

    Valuation: ~US$600 million (estimate)
    What it does: Wearable insulin delivery device + patient engagement
    Why it matters: Device + digital combo in chronic disease management

    9. Hilo Health (Switzerland/Spain)

    Valuation: ~US$300 million (estimate)
    What it does: Continuous blood pressure monitoring without cuffs
    Why it matters: Remote monitoring is crowded, but clinically meaningful, reimbursable models still rare.

    10. Nobi BV (Belgium)

    Valuation: ~US$150 million (estimate)
    What it does: Smart ambient care sensors for elderly living at home
    Why it matters:
    A realworld aging play; modest valuation, but high relevance for Europe’s demographic shift.

    What this list tells us?

    Valuation follows integration. The highest valued companies are those who figured out how to embed into care delivery systems, not just launch a product or service.
    It’s not just software. Many of the names here incorporate hardware or device components, but the business model leads with experience, outcomes, and scale.
    Europe has range. From Portugal to Sweden to France, the value creation is not limited to London/Berlin (though they still matter).
    But caution remains. Private valuations are fluid. Some said “decacorn” for Oura a year ago; latest official validated valuation is half of it at around ~$5.2bn the jump to ~$11bn comes from news speculation.

    One Last Note

    This list isn’t final, and it will change, maybe an hour after the publication. Private valuations shift. Some firms may consolidate or pivot. But if you’re looking to invest, compete or expand — these are the healthtech
    companies dominating European healthtech headlines for now.

    Next up: where the money’s coming from — and who’s still writing the big cheques.

    This content has been enhanced with GenAI.

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    Digital Health MedTech

    Europe MedTech & Digital Health — Weekly Brief (Week of 18–24 Oct 2025, #11)

    Funding stacked, boards shuffled, CE marks landed — this week runs on neurotech raises, workflow monitors, and regulator backed AI.

    People on the move

    Cardiawave (France): Jonathan Freeman becomes Board Chair as the French non invasive ultrasound outfit gears up for global expansion.

    CoMind (UK): Taavet Hinrikus, partner at Plural joins the board alongside the new round, bringing company building and scaling firepower.

    Money flows

    ONWARD Medical (UK): €50.85M private placement. Neurostimulation for spinal cord injury. Proceeds go to ARC IM development, ARC EX commercial build out in the US and Europe, and operations runway into late 2026.


    CoMind (UK): 60M USD growth round. Non invasive brain monitoring to replace surgical holes for neuromonitoring. Backers include Plural and Taavet Hinrikus who also joins the board.

    Calm Storm (Austria): €30M new fund close. Vienna based fund doubles down on health and digital across CEE and DACH with pre seed through seed checks.

    Cyclana Bio (UK): £5M pre seed. Women’s health discovery platform for endometriosis using tissue level models and AI. Co led by NfX and Eka VC.

    Median Technologies (France): Financing update. Received €19M first tranche from the European Investment Bank agreement on Oct 20 and highlighted earlier €23.9M capital increase to extend runway to at least Q4 2026 while preparing US launch of its AI lung cancer SaMD.

    On the press


    • GE HealthCare: CE mark for Carevance patient monitor, adding cardiac output insights for perioperative care, with European showcase at ESICM Munich.
    • MHRA: New AI projects to predict side effects from drug interactions and speed safer treatments. Signals growing UK emphasis on applied AI across medicines and devices.
    Femasys: Initiates EU post market surveillance for FemBloc permanent birth control, a step in the MDR commercial plan for Europe.
    Chronic care watch: Useful macro lens on why chronic care is the next healthtech frontier and where founders can build. Helpful context for EU markets leaning into long term conditions.

    One thing to remember

    Follow the money into clinically close, workflow ready tech. Neuro monitoring, perioperative hemodynamics, and women’s health discovery drew fresh capital or clearances, while regulators nudged AI into practical safety use. Founders who pair hard clinical value with clean MDR playbooks will find doors open this quarter.

    Sources

    https://sifted.eu/articles/calm-storm-closes-30m-fund
    https://sifted.eu/articles/comind-raised-60-million-cerebral-blood-flow-monitoring
    https://siliconcanals.com/onward-medical-raises-over-50m-know-more/
    https://www.businesswire.com/news/home/20251016721476/en/Carevance-platform-expands-access-to-GE-HealthCares-clinical-excellence-with-advanced-patient-monitoring-and-new-perioperative-hypotension-management-capability
    https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency

    This content has been enhanced with GenAI.

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    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