This Week in European HealthTech - Week 2 October 2025

Major developments in European HealthTech this week centred on a landmark AI regulatory approval, strategic international partnerships, and continued focus on regulatory reform.

Here are the key highlights:

1. Landmark AI Regulatory Approval

Autonomous AI Care: A significant regulatory breakthrough was reported as Flok Health's AI-powered physiotherapy clinic secured Class IIa Medical Device approval under EU regulations.

Significance: This is a major milestone, reportedly making it the first time an AI system in the UK or Europe has been approved for fully autonomous, end-to-end care, including diagnostic and treatment decisions, without constant human supervision.

Real-World Impact: Pilot data from one NHS trust showed the AI platform more than halved waiting lists for back pain.

2. Investment and Funding Activity

Investment continues to flow, particularly into AI-driven solutions:

Simple Life (UK): Secured a $35 million Series B funding round to scale its AI health coach platform, a major injection of capital into the consumer wellness space.

Early-Stage AI Scribes: There was notable funding for startups in the AI-powered administrative sector, mirroring the broader trend of automating clinical workflows:

praxipal (Germany): Raised $6.7 million in seed funding for its AI workforce aimed at German healthcare front desks.

Vocca (Voice AI): Raised $5.5 million in seed funding to bring AI phone assistants to the healthcare sector.

Drug Discovery: DaltonTx (UK) completed a £4 million seed round to advance its intelligence backbone for drug discovery, underscoring the ongoing investor appetite for TechBio.

3. Pressure on Regulatory Reform

Call for Harmonisation: MedTech Europe submitted its recommendations for the forthcoming European Innovation Act, calling for urgent and fundamental reforms to the EU's medical device regulations (MDR and IVDR).

Key Complaint: The industry group claims the existing regulations have "structural problems," leading to administrative burden, complexity, and fragmentation that is "eroding Europe's attractiveness for innovation and delaying patient access."

Proposed Fix: MedTech Europe is pushing for a more centralized governance structure and a streamlined pathway from research to market for life science innovations.

4. UK Clinical Trial Acceleration

MHRA Approval Times: The UK's Medicines and Healthcare products Regulatory Agency (MHRA)announced that its recent reforms have more than halved the time it takes to approve clinical trials, falling from 91 days to 41 days, a positive sign for biotech and medical device companies conducting research in the UK.

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