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The last week in European MedTech has been dominated by regulatory and funding activities, as well as continued momentum in digital health and surgical innovation.🇪🇺 Regulatory News and Policy The central theme continues to be the implementation and potential revision of the EU's Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).Call for Evidence on MDR/IVDR Reform: The European Commission launched a "Call for Evidence" on the future of the MDR/IVDR, seeking feedback on a targeted revision. The goal is to reduce administrative burden, improve predictability, and enable digitalization in the regulations. This consultation was a major focal point for industry last week. Industry Push for Action: Industry group MedTech Europe is actively pushing for immediate regulatory changes by early 2026. Key requests include a targeted postponement of re-certification requirements to avoid regulatory bottlenecks and the creation of a single governance structure for Notified Bodies to ensure a more efficient CE-marking system. UK Regulatory Updates: The UK's MHRA (Medicines and Healthcare products Regulatory Agency) published guidance to help manufacturers prepare for a new device registration fee set to apply from April 1st. They also reported that reforms have more than halved the time it takes to approve clinical trials, falling from 91 days to 41 days. 💰 Funding and Innovation Highlights Several companies secured funding and advanced commercial rollout of innovative technologies:Remote Monitoring: French company RDS secured 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. Cardiology Device Rollout: Elixir Medical began its full European rollout of the LithiX high-capacity Intravascular Lithotripsy (IVL) device following its CE mark. This rollout follows treatment of over 400 patients across 16 countries. AI and Robotics Investment: Medtronic plc announced it is doubling its London presence to establish a global hub for surgical robotics and AI, aligning with long-term health plan ambitions in the UK. AI for Veterinary MedTech: UK startup Lupa raised a €17 million Series A to scale its AI-native operating system for veterinary clinics, demonstrating AI's spread into adjacent healthcare sectors. 🌐 Global &amp; Other European MedTech Updates FDA Inspection Reliance: The European Medicines Agency (EMA) has begun accepting the FDA's findings from inspections of manufacturing facilities conducted outside the US, a significant step toward international regulatory harmonisation. Pharmaceutical Cost Debate: Under the UWWTD's (Urban Waste Water Treatment Directive) extended producer responsibility scheme, pharmaceutical and cosmetics industries will be required to contribute to wastewater treatment costs. This plan has received pushback from major European drugmaker trade groups.To discuss how Nelson Advisors can help your HealthTech or MedTech company, please email <a data-mce-href="mailto:lloyd@nelsonadvisors.co.uk" href="mailto:lloyd@nelsonadvisors.co.uk" title="lloyd@nelsonadvisors.co.uk" target="_blank" rel="noopener" data-mce-selected="inline-boundary">lloyd@nelsonadvisors.co.uk</a>

This Week in European MedTech - Week 3 October 2025

Major developments in European HealthTech this week have been dominated by major funding rounds in biotech, significant regulatory alignment and continued investment in digital health.Here are the key highlights:1. Record-Breaking Funding Rounds German Biotech Tubulis secured a €308 million Series C financing round. This is reported as the largest Series C ever raised by a European biotech and the largest private financing globally for an antibody-drug conjugate (ADC) developer. The funds will advance their cancer therapies, including a lead candidate in a Phase I/IIa study.Finnish HealthTech Oura (the smart ring maker) raised substantial fresh funding, valuing the company at around $11 billion, and plans to accelerate AI and product innovation globally.British investor Spex Capital announced the first €30 million commitment to its flagship €100 million Venture HealthTech Fund, aimed at global early-stage HealthTech startups.2. Regulatory &amp; International Cooperation The UK's MHRA (Medicines and Healthcare products Regulatory Agency) and the US FDA (Food and Drug Administration) announced a deeper collaboration on medical technologies and AI. This alliance aims to harmonize regulation and create new reliance routes to speed up safe access to innovative devices in the UK.The EU Data Act's obligations became applicable this week, which is a major regulatory cornerstone designed to unlock the value of data across sectors, including healthcare and life sciences, by establishing rules on data access and use.3. Product Launches and AI Adoption &nbsp; Medtronic launched its VitalFlow ECMO system in Europe, a new one-system platform for critical care.Vektor Medical secured the CE mark for vMap, an AI-assisted, non-invasive arrhythmia mapping product, allowing its entry into the EU market.There's ongoing focus on AI integration in clinical settings, with reports on major NHS trusts pushing forward with comprehensive AI strategy roadmaps.To discuss how Nelson Advisors can help your HealthTech or MedTech company, please email <a data-mce-href="mailto:lloyd@nelsonadvisors.co.uk" href="mailto:lloyd@nelsonadvisors.co.uk" title="lloyd@nelsonadvisors.co.uk" target="_blank" rel="noopener" data-mce-selected="inline-boundary">lloyd@nelsonadvisors.co.uk</a>

This Week in European HealthTech - Week 3 October 2025

Brain with AI chip inside. Artificial intelligence, Brain science, Neuro system

Artificial Intelligence (AI) is fundamentally reinventing mental healthcare by addressing critical issues of accessibility, efficiency, and personalisation, moving the field towards a more proactive, data-driven model. AI acts primarily as a powerful augmentative tool for human clinicians, rather than a replacement for them.Key Transformations Driven by AIAI is transforming mental healthcare across diagnosis, treatment, and resource management:1. Enhanced and Early DiagnosisAI excels at processing large, complex datasets to identify subtle indicators of mental health conditions earlier than traditional methods.Predictive Analytics: AI algorithms analyse data from Electronic Health Records (EHRs), speech patterns, social media activity, and wearable devices to identify individuals at high risk for conditions like depression, anxiety, or psychosis, enabling proactive intervention. Objective Screening: Natural Language Processing (NLP) analyses text and speech for linguistic markers (e.g., changes in tone, word choice, and rhythm) that correlate with mental states. Facial expression analysis can also detect subtle emotional cues. Streamlining Clinical Workflow: AI assists clinicians by sifting through complex patient data for relevant information, supporting quicker, more accurate diagnostic decisions.2. Personalised and Accessible InterventionsAI increases the reach and tailoring of mental health support.AI-Powered Chatbots and Virtual Assistants: Tools like Woebot or Wysa offer 24/7, non-judgmental support, often utilising principles of Cognitive Behavioural Therapy (CBT).They provide real-time coping strategies, emotional check-ins, and interim support between human sessions, significantly improving accessibility and reducing stigma.Tailored Treatment Plans: AI analyses a patient's unique history, genetics, symptoms, and response to previous therapies to recommend the most effective, personalised combination of medication and therapeutic modalities.Virtual Reality (VR) Therapy: AI enhances VR exposure therapy for phobias and Post-Traumatic Stress Disorder (PTSD) by dynamically adjusting virtual scenarios based on the patient's real-time physiological and psychological responses.3. Monitoring and AdherenceAI provides continuous, real-time tracking that vastly improves care management.Continuous Monitoring: Wearable devices and mobile apps, integrated with AI, monitor physiological signals (e.g., heart rate variability, sleep patterns) and behavioural data (e.g., activity levels) to track a patient’s well-being and detect early signs of relapse.Improving Compliance: AI can identify behaviuoral patterns suggesting non-adherence to treatment (medication or therapy) and send personalised reminders or alerts to both the patient and the care provider.The Future: Augmented Human CareThe future of mental healthcare is not AI replacing therapists, but rather a model of "Augmented Human Care" where technology supports and extends the capacity of clinicians. AI will handle data-intensive tasks and routine support, freeing human professionals to focus on the essential, complex, and relational aspects of therapy and treatment. This collaboration holds the promise of making mental health support more accessible, accurate, and truly individualised worldwide.To discuss how Nelson Advisors can help your HealthTech, MedTech, Health AI or Digital Health company, please email <a data-mce-href="mailto:lloyd@nelsonadvisors.co.uk" href="mailto:lloyd@nelsonadvisors.co.uk" title="lloyd@nelsonadvisors.co.uk" target="_blank" rel="noopener">lloyd@nelsonadvisors.co.uk</a>

Reinventing mental healthcare in the age of AI

Nelson Advisors invited to speak at the Health Tech Forward 2025 Conference in Barcelona: ‘Health Data Under Attack: Emerging Vulnerabilities in Healthcare’ Panel.Partner, Lloyd Price will join Laura Busquet Raich and others exploring the key vulnerabilities in health tech, medtech,and AI across Europe.‘Health Data Under Attack: Emerging Vulnerabilities in Healthcare’ PanelWith digital innovation taking over healthcare, new risks are emerging. It affects all market sectors – from diagnostics to medical devices and health apps we use. That comes down to sensitive patient data moving through increasingly complex systems. This panel will examine vulnerabilities in health tech, medtech, and AI. Experts will discuss ransomware, device security gaps, and data misuse. Join in to explore how innovation and security must advance together to protect patients and sustain trust.Health Tech Forward 2025Location: Palau de Congressos de Barcelona in Barcelona, Spain. Dates: December 3-4, 2025. Focus: Europe's premier event for health tech innovation and investment, featuring keynote speeches, dynamic panel discussions, and targeted 1:1 networking opportunities. Panel Topic Context: The panel falls under the track/topic of cybersecurity, compliance, and collaboration(often referred to as the "3C's"), addressing the critical security challenges facing the healthcare sector as it adopts new technologies.The conference agenda often covers themes ranging from AI insights and clinical breakthroughs to consumer tech &amp; wellness.<a data-mce-href="https://healthtechforward.com" href="https://healthtechforward.com" title="https://healthtechforward.com" target="_blank" rel="noopener">https://healthtechforward.com</a>

Nelson Advisors invited to speak at the Health Tech Forward 2025 Conference in Barcelona

The VIP Investor Programme at the Global Health Exhibition 2025 in Riyadh is an exclusive, invitation-only initiative designed to connect various types of investors with high-impact investment, partnership, and joint venture opportunities in Saudi Arabia's rapidly growing healthcare sector. The program aligns with the goals of Saudi Vision 2030 to transform the health sector.Key Programme Details The program is aimed at decision-makers from entities like Investment Firms, Venture Capital (VCs), Corporate VCs, and Family Offices who are interested in the Saudi healthcare landscape.Benefits: Participants receive a number of exclusive advantages, including:&gt; High-impact networking and matchmaking opportunities. &gt; Face-to-face meetings with representatives from the Ministries of Health and Investment. &gt; Access to the Investor Forum, which covers topics like investing in the Kingdom of Saudi Arabia (KSA) and the future of healthcare. &gt; Connections with key stakeholders and opportunities to explore the investment landscape and identify potential partners. &gt; Access to investor lounges and exclusive networking events.Global Health Exhibition 2025 Event Information The exhibition itself serves as a vital platform for attracting capital and showcasing innovation in line with the Kingdom's goals.Dates: October 27 – 30, 2025 (Show timings are generally 10 am – 7 pm on the first three days and 10 am – 6 pm on the last day). Venue: Riyadh Exhibition and Convention Center (Malham), Riyadh, Saudi Arabia. Theme: "Invest in Health." Key Focus Areas:&nbsp;Digital Health Life Sciences Medical Devices Imaging &amp; Radiology Laboratory Startups WellnessThe Investor Programme is a core component of the exhibition, highlighting the Venture Forum which delves into investment strategies, emerging trends, and key regulatory updates in the medical technology market. The 2024 edition alone recorded investments exceeding SAR 50 billion, underscoring the event's significance for global investor confidence in the Saudi market.To discuss how Nelson Advisors can help your HealthTech, MedTech, Health AI or Digital Health company, please email<a data-mce-href="mailto:lloyd@nelsonadvisors.co.uk" href="mailto:lloyd@nelsonadvisors.co.uk" title=" lloyd@nelsonadvisors.co.uk" target="_blank" rel="noopener"> lloyd@nelsonadvisors.co.uk</a>

Nelson Advisors invited to join the VIP Investor Programme at the Global Health Exhibition 2025

A wooden abacus with black and white beads sits on a green table. The abacus is old and has a vintage feel to it

As of October 2025, European MedTech and HealthTech valuation multiples are showing steady resilience and selective optimism, following a cautious rebound that began in early 2025. The overall sentiment is moderately bullish for high-quality, profitable, and AI-driven businesses, while smaller or unprofitable firms continue to face compressed valuations.MedTech Valuation Multiples (October 2025)EV/Revenue: The average revenue multiple for European MedTech companies is between 4x–6x, with standout innovators in areas like AI diagnostics, telemedicine, and digital surgery achieving 6x–8x revenue multiples due to premium strategic and private equity demand.&nbsp; EV/EBITDA: Profitable MedTech firms typically achieve 10x–14x EBITDA, slightly higher than 2024 averages (10x–12.5x), reflecting cautious optimism and strong M&amp;A competition for scalable companies.&nbsp; Key valuation drivers: Integration of AI and digital workflow tools within existing clinical systems.Consolidation through M&amp;A by large medical device players. Maturing regulatory clarity under the EU AI Act and European Health Data Space.HealthTech Valuation Multiples (October 2025)EV/Revenue: The average HealthTech revenue multiple is 4.8x year-to-date (YTD 2025), within a 4x–6x general range. Innovative sub-sectors—particularly AI-driven platforms, telehealth, and advanced analytics—routinely trade between 6x–8x revenue.&nbsp; EV/EBITDA: Profitable digital health firms are valued around 10x–14x EBITDA, aligning with the broader MedTech range.&nbsp; ARR Multiples: For recurring-revenue or SaaS-oriented HealthTechs, EV/ARR multiples span roughly 6x–20x, reflecting premium pricing for stable subscription-based models.&nbsp; Drivers of valuation: Proven profitability and high recurring revenue share. Alignment with value-based care and measurable cost efficiency. Data monetisation capability and secure interoperability with EHR systems. Strategic acquisitions by both private equity funds and large healthcare conglomerates.In summary, European MedTech and HealthTech valuations have stabilised around healthy mid-single-digit revenue multiples and low-teens EBITDA multiples, with continued robust interest in companies that combine profitability, AI integration, and value-based healthcare alignment.To discuss how Nelson Advisors can help your HealthTech, MedTech, Health AI or Digital Health company, please email <a data-mce-href="mailto:lloyd@nelsonadvisors.co.uk" href="mailto:lloyd@nelsonadvisors.co.uk" title="lloyd@nelsonadvisors.co.uk" target="_blank" rel="noopener" data-mce-selected="inline-boundary">lloyd@nelsonadvisors.co.uk</a>

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This Week in European MedTech - Week 3 October 2025

This Week in European HealthTech - Week 3 October 2025

Reinventing mental healthcare in the age of AI

Nelson Advisors invited to speak at the Health Tech Forwa...

Nelson Advisors invited to join the VIP Investor Programm...

European MedTech and HealthTech valuation multiples - Oct...