Tag: Europe MedTech & Digital Health — Weekly Brief

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Digital Health MedTech

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

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

People on the move

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

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

Money flows

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

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

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

On the press

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

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

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

One thing to remember


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

This content has been enhanced with GenAI.

Sources

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

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Digital Health MedTech

Europe MedTech & Digital Health Weekly Brief (Week of 4–10 October 2025, #9)

Key Developments, Funding Rounds, Launches, and Regulatory Updates

This week in European MedTech and Digital Health has seen steady progress, with notable funding rounds, product launches, regulatory milestones, and leadership changes. Key highlights include the debut of a new ECMO system, a cardiology AI solution achieving its CE mark, and enhanced regulatory cooperation between the UK and the US on AI and medical devices.

People on the Move

PBC Biomed (IRL): Mark McMahan has been appointed Chief Commercial Officer to accelerate go-to-market strategies for trauma and extremities products in the EU and US.

Merz Therapeutics (DE): The company has opened a new affiliate in Poland, with Jolanta Dilling-Sulimierska stepping in as General Manager to lead local expansion efforts.

Investment and Funding Activity

  • The Medical Travel Company (UK/India): Raised €3.8 million in a round led by Nexus Venture Partners, with participation from athlete collective 4CAST. The company focuses on building regulated cross-border care pathways for UK patients to access accredited providers in India. The new funds will support deeper partnerships in the UK and the certification of care pathways.
  • Fellos (NL): Secured €2.0 million in growth capital to expand its men’s health telemedicine services, specifically targeting erectile dysfunction and premature ejaculation. The funding will enable the company to scale operations in the Netherlands and broaden its service offering. Investors include healthcare professionals, Dutch Operator Fund, and Capital Mills. (7/10/2025)
  • NP-Hard Ventures (NL): Announced a €25 million first close for Fund II, targeting European technical founders in deeptech and automation. The fund’s remit covers medtech infrastructure and robotics—providing vital capital for enabling tools in clinical and device workflows.
  • Anasens × MAVAND: The two companies have entered into a distribution agreement for DrugAsens™ across selected EU markets and Australia. The partnership covers joint go-to-market strategies, training, and post-sales support.

Product Launches and Regulatory Updates

  • Medtronic: Launched the VitalFlow ECMO system in Europe—a one-system platform debuting at EACTS in Copenhagen. This innovation expands options for ICU and intra-hospital transport of critical care patients.
  • Vektor Medical: Secured the CE mark for vMap, an AI-assisted, non-invasive arrhythmia mapping product based on 12-lead ECG data, now entering the EU market. This technology has the potential to streamline electrophysiology workflows.
  • Philips: Achieved a milestone with the 5,000th installation of its Zenition mobile C-arm, with the milestone site at Kolín Regional Hospital in the Czech Republic.
  • UK MHRA & US FDA: Announced a deeper collaboration on medical technologies and AI, including new reliance routes and the creation of a National AI Commission. This alignment aims to speed up safe access to innovative devices.

Key Takeaway

The combination of commercial momentum and regulatory support is paving the way for faster adoption of new technologies in Europe. With the launch of ECMO and arrhythmia-mapping solutions and closer UK–US regulatory alignment, companies should focus on products that improve clinical workflow efficiency and meet notified-body evidence requirements. Investors are encouraged to keep an eye on infrastructure and peri-procedural AI, as these segments are transitioning from pilot phases to procurement.

This content has been enhanced with GenAI

Sources

https://www.eu-startups.com/2025/10/cricket-stars-help-raise-e3-8-million-for-the-medical-travel-company-and-its-cross-border-healthcare/

https://www.eu-startups.com/2025/10/dutch-mens-health-startup-fellos-lands-e2-million-to-tackle-sensitive-issues-like-ed-and-pe-through-telehealth/

https://siliconcanals.com/np-hard-ventures-launches-e25m-fund-ii/

https://news.medtronic.com/Medtronic-Cardiac-Surgery-launches-VitalFlow-TM-Extracorporeal-Membrane-Oxygenation-ECMO-system-in-Europe%2C-advancing-care-for-critically-ill-patients

https://www.businesswire.com/news/home/20251007948309/en/Vektor-Medical-Secures-CE-Mark-for-vMap-Bringing-the-Benefits-of-Non-Invasive-Arrhythmia-Mapping-to-Europe

https://www.gov.uk/government/news/patients-to-benefit-as-uk-and-us-regulators-forge-new-collaboration-on-medical-technologies-and-ai

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Digital Health MedTech

Europe MedTech & Digital Health Weekly Brief (Week of Sep 28–Oct 4, 2025, #8)

A brisk week: AI health coaching nets fresh capital, vet workflow AI gets a push, CE-marked remote monitoring scales, and Brussels opens the door for MDR/IVDR feedback.

People on the move

Dentsply Sirona: Aldo M. Denti appointed EVP & Chief Commercial Officer effective Oct 6 to align global business units with commercial execution. Mr. Denti brings extensive experience from J&J MedTech, especially DePuy (orthopaedics) and Acuvue (Vision Care).

Money flows

Simple Life (UK): €29.8M Series B, AI health coach; led by HartBeat Ventures. Plan: expand AI personalisation, gamification; claims strong revenue and active subs.

Lupa (UK): €17M Series A, AI-native operating system for veterinary clinics; launching a Veterinary AI Lab and scaling across Europe.

RDS (FR): €14M Series A to industrialise and expand MultiSense RDS, a CE-marked connected patch for continuous remote patient monitoring across Europe.

SeaBeLife (FR): €2M pre-Series A to advance dry AMD and severe acute hepatitis programs (biotech angle with medtech-adjacent implications for retina diagnostics ecosystems).

On the press

• European Commission launches a “Call for Evidence” on the future of MDR/IVDR (targeted revision to reduce burden, improve predictability, enable digitalisation). Deadline: Oct 6, 2025.
• HERA invites applications. Joint Industrial Cooperation Forum call is live; applications due by Oct 29, 2025 (17:00 CEST).
• Cardiology device rollout: Elixir Medical begins full European rollout of LithiX high-capacity IVL following CE mark; >400 patients treated across 16 countries.
• Swiss TAVI protection play advances in US. FDA clears pivotal trial for AorticLab’s FLOWer embolic protection system (already CE-marked in EU since 2024), signalling a scale-up trajectory for a Europe-born device.

One thing to remember

Regulation and reimbursement tailwinds matter: with Brussels actively revisiting MDR/IVDR and CE-marked RPM/IVL tools scaling across hospitals, founders who align early with compliance workflows and real clinical endpoints will move faster on procurement and pilots than those chasing generic “AI copilot” stories.

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Digital Health MedTech

Europe MedTech & Digital Health — Weekly Brief (Week of Sep 20–26, 2025, #7)

A brisk week: big wearable debt, a Finland-to-EU CE mark, and fresh regulatory momentum for tinnitus therapy—plus Medtronic doubles down on a London robotics and AI hub.

People on the move

Medtronic Neurovascular: Dr. Adam S. Arthur named Chief Medical Officer, effective Sept 30; brings >20 years’ neurosurgery experience to stroke care strategy.

Olympus (Smart Connected Care): Appoints Slawek Kierner as Chief Digital Officer to accelerate connected-care strategy.

Money flows

Oura (FI): Secured $250M debt facility from a bank syndicate (JPMorgan, Goldman Sachs, BofA, Barclays, Citi, Wells Fargo) to fuel growth and operations. Signals continued appetite for consumer-grade, clinical-adjacent wearables in Europe. Since launching its smart ring in 2015, the company has now sold over 5.5 million units, with more than half of those sales occurring in just the past year.

In addition to record-breaking sales, ŌURA reported more than $500 million in revenue for 2024, representing a more than 200% increase from the previous year.

Ventech (FR/EU): Closes €175M Fund VI to back ~35 European startups across Seed–Series A; mandate spans digital health among other verticals. Good news for early-stage medtech/digital health founders in FR–DE–Nordics.

Co-founder Zoar Engelman, PhD, appointed CEO of Axon Therapies

Axon Therapies (US) $32M Series A to advance heart failure therapy; co-led by Berlin-based Earlybird (EU investor read-through: continued EU GP exposure to cardio devices).

Transmedics OCS - Source: Transmedics.com

TransMedics × Mercedes-Benz (IT/EU): Strategic collaboration to launch Italy’s first dedicated organ-transport ground network (V-Class fleet) across four hubs to scale OCS perfusion logistics; part of broader EU rollout plans.

On the press

Marginum (FI): CE mark (MDR) cleared for HIVEN®, an intraoperative aspirate-tissue monitoring device to aid margin assessment in glioma surgery; Nordic clinical validation noted.

Neuromod Devices (IE): Achieves MDR certification and MDSAP; secures TGA (AU) and Health Canada approvals, ensuring ongoing EU availability and near-term international expansion for Lenire tinnitus therapy.

Medtronic (UK/EU): Doubles London presence to create a global hub for surgical robotics and AI, aligned with NHS 10-Year Health Plan collaboration ambitions.

Anova (UK/US) — Launches a global clinical registry (AnovaOS) for RWE and post-market surveillance—potentially useful for EU MDR PMCF and European study recruitment workflows.

One thing to remember

The week’s signal: European medtech commercialisation is accelerating on two tracks—scale capital (Oura debt, Ventech VI) and regulatory/market access (MDR clearances and global approvals), with major strategics (Medtronic) anchoring AI/robotics hubs in Europe. If you’re fundraising or launching in Q4, tie your story to measurable care delivery gains and MDR-ready evidence.

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Digital Health MedTech

Europe MedTech & Digital Health — Weekly Brief (Week of September 13-19, 2025, #6)

Chronic care raises capital, CE-marks keep flowing, leadership benches shift, and new data reveals just how underfunded CEE’s healthtech sector remains. I am travelling, so this brief will be, well, brief.

People on the move

Venous Stent B.V. — Darren Spencer appointed CEO to drive its iliac venous stent programme into first-in-human trials and through EU regulatory milestones. NLC Health (Sep 2025)

Data4Life (Germany) — Dr. Ben Illigens named CEO to scale its health data platform (Data2Evidence) and tighten focus on compliance and translational research. Yahoo / Data4Life (Sep 1, 2025)

Money flows

Doctor.One (Poland/Europe) — €4M Seed led by YZR Capital with Impact Ventures and existing investors. The asynchronous chronic care platform is expanding into Germany, Spain, and the UK, with pharma partnerships already underway. EU-Startups (Sep 17, 2025); EIT Health (Sep 17, 2025)

On the press

  • Johnson & Johnson Shockwave Javelin Catheter Launch — New peripheral intravascular lithotripsy catheter hits Europe, promising better outcomes for below-knee calcified lesions. Johnson & Johnson (Sep 15, 2025)
  • Roche SmartGuide + mySugr CE Mark — CE approval for Roche’s Accu-Chek SmartGuide CGM integrated with the mySugr app; rollout planned across multiple EU markets. Biospace (Sep 17, 2025)
  • AVITA Medical RECELL GO CE Mark — CE approval expands European access to RECELL GO burn care device. BioPharma Boardroom (Sep 15, 2025)
  • CEE Funding Gap Report — New EU-backed investor guide highlights that CEE health ventures raise on average €1.8M vs €4.1M across Europe, and the region captures only 3.9% of EU’s VC funding. Medvia (Sep 12, 2025)

One thing to remember

Capital is flowing, but not evenly: while Western Europe powers up chronic care and device launches, CEE healthtech founders remain chronically underfunded. For investors, this looks like arbitrage. For founders, it means sharper evidence, earlier partnerships, and bolder cross-border strategies will be key to attract scale-up capital.

This content has been enhanced with GenAI.


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Digital Health MedTech

Europe MedTech & Digital Health Weekly Brief (Week of September 6–12, 2025, #5)

Workflow AI meets hard regs: funding into clinical workforce & pathology AI, a CEE mental health roll-up, and CE marks in resuscitation, MSK and neuro-mobility.

People on the move

Haughton Design (UK) appoints Dr. Ash Ghadar as CEO to scale medtech/drug-delivery design services; a reminder that device commercialisation chops are in demand.

Allianz Partners (FR) names Okan Özdemir Chief Officer for Health & Board Member; payer-side signal for digital health distribution.

Money flows

Teton.ai (DK) $20M Series A, predictive eldercare AI; Plural leads with Bertelsmann Investments, Antler Elevate, Nebular and PSV Tech. Funds to push EU/US rollout and dataset expansion.

TERN Group (UK) €20M Series A; AI clinical workforce platform to optimise staffing across Europe & GCC; led by Notion Capital with RTP Global, LocalGlobe, EQ2, Leo Capital et al.

Aiosyn (NL) €2.4M to advance AI pathology tools for cancer diagnostics; supports validation and productisation with Dutch partners.

SafeHeal (FR) €10M Series C extension led by Asabys to accelerate EU commercial launch of Colovac and continue U.S. study.

Hedepy (CZ) acquires Poland’s HearMe (terms undisclosed) to consolidate CEE online psychotherapy; adds 80+ corporate clients and 120+ professionals; founders join leadership

On the press

• Neurescue (DK) wins CE mark under MDR for its intelligent aortic balloon catheter; the first device approved to treat non-shockable cardiac arrest in Europe.

• Varian (Siemens Healthineers) secures CE mark for Embozene microspheres in genicular artery embolisation (GAE) for knee osteoarthritis; first CE-marked embolic for GAE.

• Lifeward (IL/US) gains CE mark for ReWalk 7 personal exoskeleton; EU commercial launch enabled, with Germany a key reimbursed market.

• Report: Europe’s 10 biggest healthtech deals in H1 2025: €4B raised; UK led by volume. Useful late-stage context.

One thing to remember

Regulatory traction is back: three CE marks in one week (resuscitation, MSK pain, neuro-mobility) while capital flowed to workflow AI (staffing, lab data) and pathology. EU buyers will reward products that unblock staffing, data, and function bottlenecks.

This content has been enhanced with GenAI.

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Digital Health MedTech

Europe MedTech & Digital Health Weekly Brief (Week of August 30–September 5, 2025, #5)

Hospitals want evidence, investors want traction: this week mixed the two: GI diagnostics, insulin delivery, genomics M&A. And sprinkled in fresh CE marks for surgical robots.

People on the move

Data4Life (DE), a digital health nonprofit backed by SAP founder, Hasso Plattner, appoints Dr. Ben Illigens as CEO to steer its health data and research initiatives. Data4Life is building open source platform Data2Evidence, which is based on the international OMOP data model.

“We are at a turning point where digital technologies are fundamentally transforming research and care. My goal is to strengthen Data4Life as a bridge between clinical research, technology, and practice,”
Dr. Ben Illigens.

Lottie (UK): George Hadjigeorgiou, cofounder of ZOE, a personalized nutrition health company, joins the board of Lottie as NED, signaling deeper crossover between consumer health and eldercare ops. Lottie is a UK’s marketplace for care homes and care services.

Money flows

Kaleido Insulin Pump visualisation - Source: https://hellokaleido.com/

ViCentra (NL) — $85M Series D; insulin patch pump maker (Kaleido) fuels next-gen device development and scale-up.  Round was led by new investor Innovation Industries, a leading European deeptech venture capital firm, with matching participation from existing investors Partners in Equity and Invest-NL, alongside continued support from EQT Life Sciences and Health Innovations.

Cyted Health (UK) — €37.5M Series B; GI molecular diagnostics to improve early detection and prevention of oesophageal cancer. Round aims to expand US commercialization while consolidating NHS footprint. Investment led by EQT Life Sciences, Advent Life Sciences and British Business Bank with continued support from existing investors Morningside and BGF.

ArcaScience (FR): $7M round led by The Moon Venture; AI “benefit–risk” intelligence platform for life-sciences R&D to clean, link and query messy evidence.

Aiomics (DE) — €2M pre-Seed; clinical-grade AI agents to reduce clinical documentation burden and improve care pathways.

M2Care (FR): €26M venture-studio raise from Bpifrance’s FTA2 fund to create/develop eight healthtech projects. Other investors in M2Care are Mérieux Développement (who actully created this incubator), Institut NAOS des Sciences de la Vie, Crédit Agricole Centre-Est. 

SeqOne (FR) aquired Congenica (UK), on undisclosed terms.
This merger creates a larger AI-powered genomics software group with strong UK presence.

On the press

One thing to remember

Evidence-first commercialisation is back: capital flowed to diagnostics and chronic-care delivery while robotics snagged CE marks. A cross-border genomics deal underlined that European buyers will pay for software that shortens time-to-impact. If you’re fundraising, pair outcomes data with a path to multi-market reimbursement; if you’re buying, look for software that accelerates clinical workflows, not just visibility.

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Digital Health MedTech

Europe MedTech & Digital Health — Weekly Brief (Week of August 23–29, 2025, #4)

OrganOx metra transport. Source: OrganOx website

This week’s highlights: a landmark UK medtech exit, a €403 million EU funding boost for AI-powered devices, and strategic momentum building across Europe for medtech commercialization. Otherwise it seems we are on annual leave.

People on the move

No newly reported high-level hires, board moves, or fund leadership changes in the European medtech/digital health sector this week.

Money flows

One thing to remember

Founders: now is the time to align innovation pipelines with EU priorities—combine clinical validation and AI integration with a clear path to strategic M&A to attract both Brussels funding and corporate buyers.

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Digital Health MedTech

Europe MedTech & Digital Health — Weekly Brief (Week of Aug 16–22, 2025, #3)

AI meets approvals, mental health consolidates, and early-stage device builders get fuel — a tidy week for cardiology/ophthalmology AI, workflow rollouts, and surgical tools.

People on the move

CMR Surgical: Chris O’Hara joins as Commercial President & GM (U.S.) to drive Versius robot expansion following FDA authorization; signals Cambridge-based CMR’s acceleration of global go-to-market. Mr. O’Hara brings experience at Intuitive Surgical (a company that builds DaVinci that Versius robot is challenging) and Globus Medical (specialists in spine sugery devices), his appointment is a strategic bet from CMR Surgical.

Money flows

Nami Surgical (Glasgow, UK): $10M, Series A (opened); developing a mini ultrasonic scalpel for robotic surgery. Proceeds support product development and commercialization prep. Tech from Nami addresses a critical unmet need in the field. Ultrasonic scalpels, which use high-frequency vibrations to simultaneously cut tissue and cauterise blood vessels, are indispensable tools in modern minimally invasive surgery. What they have is 90% smaller than available competitors.

Mindler (Sweden) acquires ieso Digital Health UK on undisclosed terms; creates a cross-border digital mental health platform spanning Nordics & UK buyers (employers, insurers, public payers). As there is an urgent need to address crisis of mental health and lack of (human) specialists, platforms such us Mindler and ieso are indispensable.  Mindler is acquiring only ieso’s UK-based telecare services business, which is responsible for direct patient care delivery to the NHS. The parent company, ieso, will remain an independent entity pivoting to focus on the development and commercialisation of its evidence-based clinical AI platform, Velora, with an initial focus on the US market.

On the press

• ZEISS lands CE mark for CIRRUS PathFinder: integrated AI decision-support for OCT that flags abnormal macular B-scans and improves OCTA visualization; EU-ready software update/licence.

• Femasys secures UK MHRA approval for FemBloc: non-surgical, in-office permanent contraception; follows the company’s recent CE mark and advances European commercialization.

• Affidea x Skin Analytics: pan-European partnership to deploy Class III CE-marked AI dermatology (DERM – Deep Ensemble for the Recognition of Malignancy) across sites, starting in Romania and Lithuania with Greece next.

One thing to remember The EU’s AI-in-diagnostics momentum is real: new CE/MHRA greenlights (ZEISS, FemBloc) are pairing with deployment deals (Affidea × Skin Analytics), while funding still finds focused hardware/robotics and safety wearables (Nami Surgical, SIT). Founders: bring regulatory-grade proof and a crisp rollout plan.

This content has been enhanced with GenAI tools.

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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.