This Week in European HealthTech and MedTech: 31st October 2025

Major developments in European MedTech this week primarily include key regulatory updates, significant funding and investment in innovative technologies, and ongoing consolidation: 

1. Regulatory and Policy Focus

Medical Device Regulation (MDR/IVDR) Reform: Experts and industry bodies like MedTech Europe are expressing hopes that upcoming reforms to the EU's Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) will bring greater consistency, predictability, and reduced administrative burdens for stakeholders. The European Commission is reportedly working intensively on proposed reforms expected by December.

AI Regulation and Integration

The European Medicines Agency (EMA) has initiated a stakeholder survey to define AI priorities in medicines regulation, following the European Commission publishing draft guidance on reporting serious AI incidents under the AI Act.

The UK's MHRA (Medicines and Healthcare products Regulatory Agency) published a pilot report for Phase 2 of its AI Airlock initiative, which aims to provide a concrete pathway for generating evidence for AI-as-a-Medical-Device technologies within the NHS.

2. Product Approvals and Innovations

Guselkumab Approval for Ulcerative Colitis (UC): The European Commission approved TREMFYA (guselkumab) for subcutaneous induction through to maintenance in adults with ulcerative colitis. This marks it as the first IL-23 inhibitor with a fully subcutaneous dose regimen for UC, offering increased flexibility and self-administration options to patients.

Continuous Glucose Monitoring (CGM) Standard: MedTech Europe has backed the creation of an internationally recognized standard for CGM technologies, which is being developed by the International Standardisation Organisation (ISO) and harmonized against EU medical device regulations.

Clinical Device Innovation: Medtronic concluded the UK leg of its ACM2U Truck Roadshow, a mobile innovation hub showcasing new technologies like the Corsano multi-parameter wearable for continuous patient monitoring at home.

3. Funding and Investment

Significant Investment Rounds:

UK-based HealthTech company SheMed secured a €43 million funding round to advance its personalised women's healthcare platform.

London-based brain monitoring startup CoMind raised a $60 million growth round for its non-invasive device to measure blood flow and pressure in the brain.

Irish MedTech projects received substantial funding, including 'SensABLATE' which received €11.1 million to create shape-sensing and tissue sensing technologies for non-surgical tumour removal.

Austrian HealthTech VC Calm/Storm closed its second fund at €30 million for early-stage investment.

 4. Corporate Activity

Acquisitions: French company FIM Medical acquired Germany-based Vistec, a specialist in vision screening devices, making FIM Medical the largest developer and distributor of European occupational healthcare devices by revenue, demonstrating a trend of consolidation for international expansion.

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This week in European HealthTech saw a wave of major funding rounds, strategic acquisitions, and innovations in AI-driven care and medical devices. Investor confidence remains strong, especially in specialised and personalised health platforms, while market consolidation continues among device makers.

1. Funding and Venture Capital

Austrian HealthTech VC Calm/Storm closed a €30 million fund, already supporting 25 early-stage companies.​

Human Health, a London-based precision health startup, raised €4.7 million to expand its AI-powered, patient-first platform for chronic care and multi-condition support.​

Plural invested $60 million in London’s CoMind, which is developing a novel non-invasive brain monitoring device.​

2. Major M&A and Market Moves

AstraZeneca acquired Belgian startup EsoBiotec for up to $1 billion, aiming to accelerate in vivo cell therapies for cancer.​

FIM Medical in France grew to the largest occupational health device distributor in Europe by acquiring Vistec, a German vision screening company.​

3. Regulatory and Product Developments

GE HealthCare earned CE mark for its Carevance patient monitor, debuting advanced perioperative cardiac output capabilities at a major Munich conference.​

The UK’s MHRA initiated new AI projects to improve drug safety and accelerate treatment pathways, reflecting widespread AI adoption in digital health across Europe.​

4. Sector Trends

AI-driven solutions and remote monitoring continue to command the highest valuation premiums, with investors rewarding clinically validated, scalable platforms—especially those integrating directly into clinical workflows or managing chronic care.​

Chronic and long-term condition management is now a central focus, due to rising demand and wait times in European health systems. Solutions that streamline patient data and care pathways, like Human Health’s AI platform, are gaining rapid traction.​

5. International Expansion

Asian HealthTech firms such as VUNO and Kakao Healthcare are entering Europe, making new regulatory and partnership moves for AI-powered diagnostics in cardiac and chronic disease management.​

Overall, European HealthTech in late October 2025 is marked by sustained capital inflow, breakthroughs in AI-powered patient care, strategic consolidation of device distributors, and growing interest in AI for regulatory, monitoring, and population health applications.

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