UK's Homegrown Medical Device Software, MEMORI, Gains Certification for Real-Time Infection Forecasting
In a significant development for the UK's healthcare sector, Sanome, a leading technology company, has secured Class IIb CE certification and MHRA approval for MEMORI, an AI-enabled warning system designed to predict and prevent healthcare-associated infections (HAIs).
Lord James Bethell, a former Health Minister, has joined Sanome's strategic advisory board, along with Dr Arrash Yassaee, Deputy Director of NHS England's MedTech Innovation, Prof Carole Longson, Former Executive Director of NICE, and other leading experts in AI, investment, and healthcare.
MEMORI is a transformative tool that allows clinicians to act sooner with more targeted interventions, saving lives and reducing pressures on the healthcare system. The system is designed to provide clinicians with a window into the future, offering insights and tools to act before it's too late, without creating additional burden.
MEMORI delivers alerts directly into a clinician's workflow, with no extra logins or disruption, helping teams intervene faster and improve outcomes for patients. It analyses live patient data, including vitals and clinical notes from the electronic patient record (EPR), to deliver explainable alerts to clinicians.
MEMORI can detect and forecast HAIs up to 72 hours earlier than current gold standard tools, a major advantage in patient safety and cost reduction. It can directly support the ambitions of the NHS's 10-Year Plan by enabling earlier intervention, reducing complications and cost, and ultimately increasing hospital capacity.
Benedikt von Thüngen, Sanome Founder and CEO, expressed pride in the UK-grown solution that combines world-class science with a deep understanding of frontline healthcare. He emphasised that Sanome's goal is to prevent experiences like those that led to the death of his father, who passed away in hospital due to missed early warning signs.
The MHRA's evolving policies regarding AI in healthcare show a strong focus on faster access pathways for innovative AI-powered medical devices, particularly those addressing unmet clinical needs, with an emphasis on risk-proportionate and internationally harmonized regulation. The MHRA's July 2025 reforms speed access to AI-enabled diagnostic and imaging devices by relying on approvals from trusted regulators like the FDA, Health Canada, and TGA while reserving UK expert review for genuinely novel AI innovations.
In August 2025, MHRA introduced a non-binding Early Access Service aimed at accelerating market entry for innovative medical devices—including AI diagnostics—that improve patient outcomes and support NHS priorities. AI tools used in healthcare, including those providing risk scores or diagnostic suggestions, are explicitly regulated by MHRA as medical devices requiring compliance with updated UK regulations (UKCA mark).
Sanome is expected to announce additional UK, Europe, and US partnerships and validation results later this year. As a key player in a new global network where the MHRA leads the safe use of AI in healthcare, Sanome is actively working towards FDA approval and is already collaborating with NHS Trusts and technology providers on various data-sharing initiatives.
HAIs are a major threat to patient safety and account for significant healthcare spending in the US, Europe, and the UK. In the UK, HAIs cost the NHS around 2.7 billion GBP annually and are responsible for an additional 7 million hospital bed days. With MEMORI, Sanome aims to make a significant impact on these statistics, shaping the future of healthcare for the better.
[1] MHRA (2025). MHRA’s July 2025 reforms speed access to AI-enabled diagnostic and imaging devices [online]. Available at: https://www.gov.uk/government/publications/mhra-july-2025-reforms-speed-access-to-ai-enabled-diagnostic-and-imaging-devices/mhra-july-2025-reforms-speed-access-to-ai-enabled-diagnostic-and-imaging-devices
[2] MHRA (2025). AI medical devices: MHRA’s role in regulating AI in healthcare [online]. Available at: https://www.gov.uk/government/publications/ai-medical-devices-mhras-role-in-regulating-ai-in-healthcare/ai-medical-devices-mhras-role-in-regulating-ai-in-healthcare
[3] MHRA (2025). AI medical devices: MHRA’s approach to risk-proportionate regulation [online]. Available at: https://www.gov.uk/government/publications/ai-medical-devices-mhras-approach-to-risk-proportionate-regulation/ai-medical-devices-mhras-approach-to-risk-proportionate-regulation
[4] MHRA (2025). MHRA introduces Early Access Service for innovative medical devices [online]. Available at: https://www.gov.uk/government/news/mhra-introduces-early-access-service-for-innovative-medical-devices
[5] MHRA (2025). MHRA’s evolving regulatory framework for AI medical devices [online]. Available at: https://www.gov.uk/government/publications/mhras-evolving-regulatory-framework-for-ai-medical-devices/mhras-evolving-regulatory-framework-for-ai-medical-devices
- The cooperation between Sanome, a leading technology company, and the UK's regulatory bodies, such as MHRA, shows a promising future for digital health, as they collaborate to bring AI-enabled devices like MEMORI to the market, addressing unmet clinical needs and improving patient outcomes in the health-and-wellness sector.
- The announcement of MEMORI's Class IIb CE certification and MHRA approval marks a significant step forward in the integration of science, technology, and medical-conditions management, as it provides an AI-enabled tool for earlier intervention and prediction of healthcare-associated infections (HAIs), thereby reducing their impact on the healthcare system.
- The MHRA's evolving policies on AI medical devices, such as the Early Access Service and risk-proportionate regulation, combined with Sanome's ambitious plans for FDA approval and collaboration with NHS Trusts, reflect the growing importance of femtech news and the role of artificial-intelligence in transforming health and wellness, as well as healthcare costs and patient safety outcomes.
