UK-based MEMORI's software, now certified as a medical device, is the nation's first to predict real-time infections in a software-as-a-medical-device capacity.
In a significant move for digital health and AI news, Sanome, a UK-based company, has secured Class IIb CE certification and MHRA approval for MEMORI, an AI-enabled warning system designed to predict healthcare-associated infections (HAIs) early.
MEMORI, the first UK-built AI tool to reach this milestone, is poised for real-world use across the UK and Europe's public and private healthcare organisations. The system analyses live patient data, including vitals and clinical notes from the electronic patient record (EPR), and delivers explainable alerts directly into a clinician's workflow.
Lord James Bethell, a member of Sanome's expert advisory board, has hailed MEMORI as a transformative tool. He stated that MEMORI allows clinicians to act sooner with more targeted interventions, saving lives and reducing pressures on the healthcare system. Bethell and his fellow board members, including Dr Arrash Yassaee, Prof Carole Longson, Dr Michelle Tempest, Pam Garside, and Dr Cem Baydar, have firsthand experience in achieving radical change in healthcare.
The MHRA's current role in regulating AI-enabled healthcare tools, including health-associated infection prediction systems like MEMORI, is focused on streamlining and modernizing access with a strong emphasis on innovation, safety, and risk-proportionate regulation.
Faster, risk-based regulatory pathways are being introduced by the MHRA, aiming to speed access for innovative AI medical devices. The MHRA's Early Access Service, launched on July 31, 2025, is designed to provide quicker market entry for innovative medical devices addressing unmet NHS clinical needs or significantly improving patient outcomes, explicitly including diagnostic devices that could cover infection prediction systems.
Sanome is actively involved in various data-sharing initiatives with NHS Trusts and technology providers. The company's Founder and CEO, Benedikt von Thuнгen, stated that MEMORI was created to prevent experiences like his father's, where early warning signs were missed.
MEMORI is capable of detecting and forecasting HAIs up to 72 hours earlier than current gold standard tools. This early detection could help the NHS achieve its 10-Year Plan by enabling earlier intervention, reducing complications and cost, and increasing hospital capacity.
Sanome is working towards FDA approval and is expected to announce additional partnerships and validation results later this year. With the MHRA poised to become a global leader in risk-proportionate regulation of MedTech, the future of MEMORI and AI-enabled healthcare tools in the UK looks promising.
References:
[1] MHRA (2025). MHRA's New Strategy for AI-Enabled Medical Devices. [online] Available at: https://www.gov.uk/government/publications/mhra-strategy-for-ai-enabled-medical-devices/mhra-strategy-for-ai-enabled-medical-devices
[2] MHRA (2025). Innovative Devices Access Pathway (IDAP). [online] Available at: https://www.gov.uk/guidance/innovative-devices-access-pathway-idap
[3] MHRA (2025). Unmet Clinical Need Authorisation (UCNA). [online] Available at: https://www.gov.uk/guidance/unmet-clinical-need-authorisation-ucna
[4] NHS (2025). Early Access Service for Innovative Medical Devices. [online] Available at: https://www.gov.uk/guidance/early-access-service-for-innovative-medical-devices
- The significant move in digital health and AI news involves Sanome's MEMORI, an AI-enabled warning system designed to predict healthcare-associated infections (HAIs) early, which has secured Class IIb CE certification and MHRA approval.
- Front-line clinicians can benefit from MEMORI, as it enables them to act sooner with more targeted interventions, leveraging artificial intelligence to analyze live patient data, including vital signs and clinical notes from the electronic patient record (EPR), and delivering explainable alerts directly into their workflow.
- With the MHRA's focus on streamlining and modernizing access to AI-enabled healthcare tools, faster, risk-based regulatory pathways are being introduced, allowing innovative AI medical devices like MEMORI to have quicker market entry, potentially reducing complications, costs, and increasing hospital capacity.
