UK's homegrown software, MEMORI, gains medical certification as a real-time infection predictor tool
Sanome's MEMORI System Achieves Significant Milestone in AI-Powered Healthcare
In a significant stride forward for the UK's healthcare sector, Sanome, a leading player in data-sharing initiatives with NHS Trusts and technology providers, has secured Class IIb CE certification and MHRA approval for its AI-enabled warning system, MEMORI. This system is designed to predict healthcare-associated infections (HAIs) up to 72 hours earlier than current gold standard tools.
MEMORI, a UK-built AI tool, is poised to revolutionise the way clinicians approach patient care. Lord James Bethell, a former Minister for Innovation in the Department of Health and Social Care, has hailed MEMORI as a "transformative tool" that allows clinicians to act sooner with more targeted interventions, saving lives and reducing the pressures on the healthcare system.
Benedikt von Thüngen, Sanome's Founder and CEO, emphasised that MEMORI was created with a personal touch. It was inspired by his father's experience of missed early warning signs in a hospital setting. MEMORI delivers explainable alerts directly into a clinician's workflow, with no extra logins or disruption, providing clinicians with insights and tools to act before it's too late, without creating additional burden.
The MHRA, a UK regulatory body, is leading the safe use of AI in healthcare as part of a new global network. The regulatory body is actively strengthening regulations for AI medical devices through updated guidelines, a completed AI sandbox pilot, and enhanced post-market data collection effective June 2025. The MHRA supports rapid, safe innovation access via schemes like IDAP and the newly announced Early Access Service, prioritising diagnostics addressing NHS clinical needs.
Sanome's expert advisory board, consisting of Lord James Bethell, Dr Arrash Yassaee, Prof Carole Longson, Dr Michelle Tempest, Pam Garside, and Dr Cem Baydar, brings firsthand experience in healthcare to the company, supporting its role in shaping the future of healthcare.
As Sanome works towards FDA approval and collaborates with NHS Trusts and technology providers on data-sharing initiatives, it is expected to announce additional partnerships and validation results in the UK, Europe, and US later this year. By enabling earlier intervention, reducing complications and cost, and increasing hospital capacity, MEMORI aligns with the ambitions of the NHS's 10-Year Plan.
It is worth noting that the MHRA's approval or current regulatory status of the Sanome MEMORI system is not explicitly stated in the available documents, implying either the decision is not public or it is in ongoing evaluation. However, the MHRA's recent introduction of an "Early Access Service" for innovative medical devices, including diagnostics addressing unmet clinical needs, offers faster, risk-proportionate regulatory pathways building on existing schemes like the Innovative Devices Access Pathway (IDAP).
In conclusion, Sanome's MEMORI system represents a significant step forward in the field of AI-powered healthcare, with the potential to transform patient care and alleviate pressures on the healthcare system. As the MHRA continues to evolve its regulatory framework for AI-enabled health tools, Sanome is well-positioned to contribute to the future of healthcare, with the support of its expert advisory board and collaborations with NHS Trusts and technology providers.
- The significant milestone achieved by Sanome's MEMORI system in AI-powered healthcare has been setting new standards in digital health, revolutionizing health-and-wellness practices by predicting healthcare-associated infections (HAIs) early.
- The MHRA's efforts to lead the safe use of AI in healthcare, especially through the introduction of an "Early Access Service" for innovative medical devices, are a testament to the importance of science and technology in addressing medical-conditions and improving artificial-intelligence-powered health solutions.
- As Sanome's MEMORI system aligns with the ambitions of the NHS's 10-Year Plan by enabling earlier intervention, reducing complications and cost, and increasing hospital capacity, the future of femtech news and digital health promises significant progress and innovation.
