This Week in European HealthTech and MedTech: 24th October 2025

Major developments in European HealthTech this week have been characterised by significant funding rounds, strategic M&A, and continued focus on AI-driven specialized care:

Major Funding and Investment

Women's Health Funding: UK-based HealthTech company SheMed announced a €43 million funding round to advance its personalized women's healthcare platform, particularly its GLP-1 program. This highlights the growing investor confidence in women's health and metabolic care platforms in Europe. 

Venture Capital Activity:

Austrian HealthTech VC Calm/Storm closed its second fund at €30 million, which is already deployed across 25 companies, signaling sustained early-stage investment interest.

 Plural backed brain monitoring startup CoMind in a $60 million round. The London-based startup develops a non-invasive device to measure blood flow and pressure in the brain.

M&A and Market Consolidation

Occupational Health Devices: French company FIM Medical acquired Germany-based Vistec, a specialist in vision screening devices. This acquisition makes FIM Medical the largest developer and distributor of European occupational healthcare devices by revenue, demonstrating a trend toward consolidation for international expansion.

Pharma/Life Sciences Deal: AstraZeneca made a strategic move by acquiring Belgian pioneer EsoBiotec for an upfront payment of $425 million (with the potential to reach $1 billion), aiming to accelerate its in vivo cell therapy platform for cancer treatments.

 Regulatory and Policy Focus

AI Regulatory Pathways: The UK's MHRA (Medicines and Healthcare products Regulatory Agency) published a pilot report for Phase 2 of its AI Airlock initiative, which provides a concrete pathway for generating evidence for AI-as-a-Medical-Device technologies within the NHS. This indicates continued, structured efforts to integrate AI into clinical practice.

These developments underscore key themes in European HealthTech: the rise of specialized virtual clinics (like women's health platforms), the increasing application of AI in clinical settings (from diagnostics to admin), and strategic M&A aimed at expanding geographic reach and product offerings.

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Major developments in the European MedTech sector this week were centered on significant funding rounds for next-generation devices, the continuous integration of AI into diagnostics and operations, and progress in complex clinical trials.

Key MedTech Developments

1. Major Funding for Next-Gen Devices and Operations

Non-Invasive Neuro-Monitoring: London-based HealthTech startup CoMind secured a substantial funding round of €51 million (bringing its total funding to over €85 million). The capital will be used to scale its non-invasive neuromonitoring technology, which measures critical brain parameters without the need for surgery. This highlights investor confidence in non-invasive diagnostic devices.

AI for Remote MedTech Operations: Germany's roclub raised €10 million in Series A funding. The company operates an AI-powered teleoperation platform to remotely manage and utilize MedTech equipment, addressing workforce shortages and improving equipment utilization across hospitals and clinics.

Irish Government Funding: Ireland's Disruptive Technologies Innovation Fund (DTIF) announced €36.9 million in funding for six new projects, including MedTech initiatives focused on:

Developing ablation, shape-sensing, and tissue-sensing technologies for non-surgical tumor and irregular heartbeat removal (SensABLATE).

Creating a new vascular closure device (VCD) to stop bleeding quickly and safely during invasive procedures (Spiorad).

2. Clinical Trial Progress for Complex Devices

Tricuspid Valve Replacement: Venus Medtech's device, Cardiovalve, announced the successful completion of patient enrollment (150 patients) in its TARGET study for Transcatheter Tricuspid Valve Replacement (TTVR).This marks a critical milestone as the company advances toward its European CE Mark submission and a targeted 2027 commercial launch.

European Clinical Trial Kick-Off: The US company Anteris received its first European regulatory clearance in Denmark to commence the PARADIGM pivotal trial for its DurAVR transcatheter heart valve, with Danish patient recruitment slated for Q4 2025.

3. Regulatory Environment and AI in MedTech

AI in Diagnostics Certification: German company Vara was granted a CE certificate for its AI breast-imaging software. This allows the technology to be deployed across the EU as an independent second reader and decision-support tool in screening and diagnostics.

AI Regulation Challenges: The European Association of Medical devices Notified Bodies (Team-NB) issued a warning that a shortage of designated Notified Bodies to review Artificial Intelligence (AI) devices could "massively hinder" the transition to the EU's AI Act, highlighting a future regulatory bottleneck.

UK's AI Pathway: The UK's MHRA (Medicines and Healthcare products Regulatory Agency) selected seven technologies for Phase 2 of its AI Airlock program, publishing a pilot report. This initiative provides a tangible, controlled pathway for companies to generate the necessary evidence for AI-as-a-Medical-Device technologies within the NHS framework.

Harmonised Standards Update: The European Commission updated an implementing decision on harmonized standards for certain medical devices, specifically adding new requirements and test methods for surgical clothing/drapes, medical face masks, and sterilizers for medical purposes.

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