Tag: Europe MedTech & Digital Health — Weekly Brief

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
Digital Health MedTech

Europe MedTech & Digital Health Weekly Brief (Week of Dec 13–19, 2025, #19)

This week: primary-care “rollup + AI” gets real money, non-invasive metabolic wearables keep attracting believers, and Brussels finally brought out the MDR/IVDR wrench set. It is silent for the end year festive break. Note, that also our weekly brief will stop until 9th of January.

Festive Break Notice

This will be the last Weekly Brief of 2025. We’re taking a short festive pause and will return with the next edition on January 9th. If Brussels sneaks out any last-minute surprises, we’ll catch them in the first January roundup.

A big thank-you to all the founders, operators, investors, clinicians, regulators, and quietly heroic compliance teams pushing European medtech and digital health forward.

Wishing you a restful break, clearer pipelines, faster CE paths, and fewer “please clarify” emails in 2026. Here’s to another year of building, fixing, and occasionally disrupting healthcare across Europe.

See you in January.

People on the move

European Innovation Council (EIC) — The Commission appointed the new EIC Board, which steers one of Europe’s biggest deeptech funding engines (relevant for medtech spinouts and scale-ups hunting EIC Accelerator/EIC Fund routes).

Money flows

Jutro Medical (Poland) €24M Series A extension (bringing Series A to €36M); scaling an AI-enabled primary care operator model (own clinics + own EHR + AI agents for admin).

Liom (Switzerland) €13.9M (CHF 13M) Series A extension (Series A now CHF 38M, total funding CHF 63M) to push its non-invasive glucose-monitoring wearable platform toward a miniaturised form factor.

Lucis (France) €7.2M ($8.5M) Seed led by General Catalyst (with YC and others) to expand preventive health testing and its biomarker dashboard across European markets.

Smile Genius (Ireland) €850k raised to date, with fresh backing cited from Enterprise Ireland, Haatch (UK) and angels; building dental clinic–lab workflow software and expanding across UK/Ireland.

On the press

EU MDR/IVDR reform (finally, a real proposal).
The Commission published a proposal to simplify and reduce burden in MDR/IVDR (including digitalisation and targeted changes), kicking off the next legislative phase with Parliament/Council.

EU digital health market access, still fragmented
France Digitale launched a petition calling for a unified EU framework to evaluate digital innovation, drawing on work coordinated by EIT Health’s task force on digital medical devices.

CE registration: point-of-care biopsy support tool enters EU market
CellTivity Scientific says its Van Gogh™ Microscopy System received CE registration (Class A under IVDR, per the release), enabling clinical use and commercial distribution across the EU.

One thing to remember

Capital is still flowing to “close-the-loop” models (care delivery + workflow software + automation) and to ambitious sensing platforms, but the biggest medium-term lever might be regulatory plumbing: if the MDR/IVDR simplification proposal holds together, 2026 could be the year Europe makes compliance timelines feel less like a hostage situation.

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 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

    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.

    Categories
    Digital Health MedTech

    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.

    Categories
    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.

    Categories
    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.