Sanome's AI Platform MEMORI Receives Class IIb CE Certification for Early Healthcare-Associated Infection Detection
Key Insights
MEMORI (search) becomes the first UK-developed AI medical device to achieve Class IIb CE certification and MHRA approval, enabling early prediction of healthcare-associated infections (search) up to 72 hours before current standards.
The AI platform analyzes live patient data including vital signs and clinical notes to deliver explainable alerts directly into clinicians' workflows without disruption.
Healthcare-associated infections (search) cost the NHS approximately £2.7 billion annually and account for 7 million additional hospital bed days, representing a major patient safety threat.
Sanome (search) has achieved a significant regulatory milestone with its AI-powered MEMORI (search) platform becoming the first UK-developed artificial intelligence medical device to secure Class IIb CE certification and MHRA approval for early detection and prediction of healthcare-associated infections (search) (HAIs (search)). The breakthrough positions the company to deploy its technology across NHS trusts and European healthcare systems while pursuing FDA approval for the US market.
Addressing a Critical Healthcare Challenge
Healthcare-associated infections (search) represent a substantial burden on global healthcare systems, with costs reaching $28.4-45 billion in the US and €13-24 billion in Europe. In the UK specifically, HAIs (search) cost the NHS approximately £2.7 billion annually and are responsible for an additional 7 million hospital bed days each year, highlighting the urgent need for preventive solutions.
MEMORI (search) addresses this challenge by analyzing live patient data, including vital signs and clinical notes from electronic patient records, to forecast HAI likelihood up to 72 hours earlier than current gold standard tools. The platform delivers explainable alerts directly into clinicians' workflows without requiring additional logins or causing workflow disruption.
Regulatory Achievement and Clinical Impact
The Class IIb certification represents one of the most rigorous regulatory standards for medical software in Europe, covering devices used to support diagnosis and clinical management. This milestone demonstrates MEMORI (search)'s readiness for real-world deployment across public and private healthcare organizations in the UK and Europe.
"MEMORI (search) is about giving clinicians a window into the future, providing them insights and tools to act before it's too late, and crucially, without creating additional burden," said Benedikt von Thüngen, Sanome (search) Founder and CEO. "Achieving Class IIb certification is a major milestone in our journey and proves we can do that safely and at scale."
Strategic Leadership Expansion
Sanome (search) has strengthened its strategic advisory board with the appointment of several high-profile healthcare leaders, including former Health Minister Lord James Bethell, Prof Carole Longson (former Executive Director of NICE and ABPI), and Dr Arrash Yassaee (Deputy Director NHS England of MedTech Innovation).
Lord Bethell emphasized the clinical significance of early infection detection: "Like many people, I've had friends and relatives hit by unexpected infections in hospital, sometimes with serious implications for their care. I know from personal experience that catching the signs early is critically important, for their care, for the resources needed for treatment and sometimes the difference between life and death."
He added that MEMORI (search) represents "a transformative tool that allows clinicians to act sooner with more targeted interventions, saving lives, and reducing the pressures on an already burdened system."
Market Expansion and Future Development
The company is actively collaborating with NHS Trusts and technology providers on various data-sharing initiatives while working toward FDA approval for the US market. Sanome (search) expects to announce additional partnerships and validation results across the UK, Europe, and US later this year.
The platform's ability to enable earlier intervention aligns with the NHS's 10-Year Plan objectives by potentially reducing complications and costs while increasing hospital capacity through more efficient resource utilization.