This Week in European HealthTech and MedTech: 5th October 2025

Nelson Advisors
2 hours ago
5 min read

The top stories in European HealthTech this week are heavily focused on AI adoption, major regulatory milestones, and significant funding activity.

Here are the key highlights:

1. AI Regulation Breakthrough for Autonomous Care

AI Physiotherapist Approved for Autonomous Decisions: A significant development saw Flok Health's AI-powered physiotherapy clinic secure Class IIa Medical Device approval under EU regulations. This is a major regulatory milestone, as it grants the AI system clearance to make diagnostic and treatment decisions without human supervision, effectively delivering an entire end-to-end care pathway autonomously. This is reported to be the first time an AI system in the UK or Europe has been approved for fully autonomous end-to-end care.

2. Notable Funding Rounds

The week has seen fresh capital injection for AI-powered and wellness platforms:

Simple Life's Major Series B: The London-based wellness and fitness app, Simple Life, secured a $35 million Series B funding round to scale its AI health coach platform.

praxipal's Seed Funding: Berlin-based startup praxipal landed $6.7 million to continue building its AI workforce designed for healthcare front desks in Germany.

Vocca's Seed Round: The voice AI startup Vocca raised $5.5 million in seed funding to bring AI phone assistants to the healthcare sector.

DaltonTx Seed Funding: UK-based technology company DaltonTx exited stealth and completed a £4 million seed round to advance its intelligence backbone for drug discovery.

3. Focus on Digital Health in Healthcare Systems (Primarily UK/NHS)

Major Digital Strategy and Procurement: Several health systems across the UK are pushing forward with significant digital transformation projects:

University Hospitals Birmingham is seeking a £2 million integrated digital patient pathway platform.

GOSH (Great Ormond Street Hospital) shared a study into an AI scribe pilot across nine London NHS sites, and also outlined its comprehensive AI strategy roadmap.

Lincolnshire Community and Hospitals NHS Group launched its digital strategy to 2028.

Pilot data showed that Flok Health's AI physiotherapy platform had a measurable impact, more than halving waiting lists for back pain at one NHS Trust.

4. Innovation in Diagnostics and Patient Monitoring

Regulatory Approvals for Danish Startups:

Evido Health obtained regulatory approval (CE-certificate, IVDR cl-b) for its data-driven clinical tool,

LiverPRO, aimed at timely detection and intervention for Chronic Liver Disease (CLD).

BrainCapture received CE marking for its pioneering, affordable EEG solution.

WARD 24/7 received FDA Clearance for its WARD-CSS® (Clinical Support System), a Software as a

Medical Device (SaMD) for continuous patient monitoring.

In summary, the European HealthTech landscape is demonstrating strong momentum, particularly in the fields of AI-driven clinical applications with a landmark regulatory approval, sustained early-stage and growth-stage funding, and continuous digital modernisation efforts within public healthcare systems.

The major stories in the world of European MedTech this week are dominated by regulatory activity under the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), a significant European Commission "Call for Evidence" for future reforms, and fresh funding for companies focused on connected and remote monitoring devices.

Here are the top stories:

1. Regulatory Pressure and Calls for MDR/IVDR Reform

The central theme this week is the ongoing industry push for revisions and accommodations within the European Union's medical device regulations (MDR/IVDR):

EU Call for Evidence for MDR/IVDR Future: The European Commission launched a "Call for Evidence" on the future of the MDR/IVDR, specifically a targeted revision aimed at reducing administrative burden, improving predictability, and enabling digitalisation. The deadline for industry feedback is October 6, 2025, making this the most time-sensitive policy story this week.

MedTech Europe's Push for Immediate Action: The industry body, MedTech Europe, continued to press the EU for immediate regulatory changes by early 2026. Their requests include:

A targeted postponement of re-certification requirements for devices already certified under the existing regulations to avoid a "new major bottleneck" before the 2028 deadline.

The creation of a single, accountable governance structure to oversee the network of Notified Bodies (NBs), aiming to ensure a more efficient and globally competitive CE-marking system.

The launch of planned pilots for expedited regulatory pathways for orphan, pediatric, and breakthrough devices.

Regulatory Milestones: The industry saw updates on several detailed compliance issues:

Confirmation of the Master UDI-DI (Unique Device Identification) implementation date for contact lenses being postponed to November 9, 2026.

Publication of new guidance on addressing incomplete Technical Files for IVDR submissions from Team-NB.

Updates on the status of MDR/IVDR implementation and the gradual rollout of the EUDAMED database.

2. MedTech Product Rollout and Commercial Growth

Cardiology Device Rollout: Elixir Medical began its full European rollout of the LithiX high-capacity Intravascular Lithotripsy (IVL) device following its CE mark, with over 400 patients already treated across 16 countries. This marks a significant market entry for a new cardiology technology.

3. Key MedTech Funding and Expansion

Recent funding activity highlights strong investment interest in both digital and hardware-based medical solutions:

Remote Monitoring Device Funding: RDS (France) raised a €14 million Series A round to industrialise and expand its MultiSense RDS, a CE-marked connected patch for continuous remote patient monitoring across Europe.

AI for Veterinary MedTech: Lupa (UK) secured a €17 Million Series A to scale its AI-native operating system for veterinary clinics and launch a dedicated Veterinary AI Lab in Europe, demonstrating the spread of MedTech innovation into adjacent healthcare sectors.

Big Tech Investment in Surgical Robotics: Medtronic plc announced it is doubling its London presence to create a global hub for surgical robotics and AI, aligning with the ambitions of the NHS 10-Year Health Plan.

4. Broader Context and Industry Movement

Staffing and Leadership: Dentsply Sirona appointed a new EVP & Chief Commercial Officer to align its global business units with commercial execution, with the new executive bringing extensive experience from J&J MedTech.

Global Trade Impact: European MedTech firms are closely watching the potential impact of a US Section 232 investigation and its potential to introduce tariffs, particularly monitoring whether it could override the Nairobi Protocol, which bans tariffs on products for people with disabilities.

Nelson Advisors > MedTech and HealthTech M&A

Nelson Advisors specialise in mergers, acquisitions and partnerships for Digital Health, HealthTech, Health IT, Consumer HealthTech, Healthcare Cybersecurity, Healthcare AI companies based in the UK, Europe and North America. www.nelsonadvisors.co.uk

Nelson Advisors regularly publish Healthcare Technology thought leadership articles covering market insights, trends, analysis & predictions @ https://www.healthcare.digital

We share our views on the latest Healthcare Technology mergers, acquisitions and partnerships with insights, analysis and predictions in our LinkedIn Newsletter every week, subscribe today! https://lnkd.in/e5hTp_xb

Founders for Founders > We pride ourselves on our DNA as ‘HealthTech entrepreneurs advising HealthTech entrepreneurs.’ Nelson Advisors partner with entrepreneurs, boards and investors to maximise shareholder value and investment returns. www.nelsonadvisors.co.uk

#NelsonAdvisors #HealthTech #DigitalHealth #HealthIT #Cybersecurity #HealthcareAI #ConsumerHealthTech #Mergers #Acquisitions #Partnerships #Growth #Strategy #NHS #UK #Europe #USA #VentureCapital #PrivateEquity #Founders #BuySide #SellSide #Divestitures #Corporate #Portfolio #Optimisation #SeriesA #SeriesB #Founders #SellSide #TechAssets #Fundraising #BuildBuyPartner #GoToMarket #PharmaTech #BioTech #Genomics #MedTech