U.K.-based software, dubbed MEMORI, gains first certification as a medical device, able to predict infections in real-time
In a significant development for the healthcare sector, Sanome's AI-enabled warning system, MEMORI, has secured Class IIb CE certification and MHRA approval. This UK-built tool is designed to predict and prevent Healthcare-Associated Infections (HAIs) up to 72 hours earlier than current gold standard tools.
MEMORI was created with a personal mission in mind. Benedikt von Thuнгen, Sanome's Founder and CEO, stated that the system was developed to prevent experiences like his father's, where early warning signs were missed in a hospital setting. Lord James Bethell, a former Health Minister and member of the House of Lords, praised MEMORI as a transformative tool that allows clinicians to act sooner with more targeted interventions, saving lives and reducing the pressures on an already burdened system.
The AI system analyses live patient data, including vitals, and clinical notes from the electronic patient record (EPR), delivering explainable alerts directly into a clinician's workflow. This approach aims to give clinicians a window into the future, providing insights and tools to act before it's too late, without creating additional burden.
MEMORI's Class IIb certification is among the most rigorous for medical software in Europe, covering devices used to support diagnosis or clinical management. This significant milestone in Sanome's journey demonstrates the ability to do so safely and at scale.
The company is expected to announce additional partnerships and validation results in the UK, Europe, and US later this year. Sanome is also collaborating with NHS Trusts and technology providers on various data-sharing initiatives, with a focus on securing FDA approval.
The global network supporting safe AI use in healthcare now spans major regulatory bodies from North America, Europe, and Asia-Pacific. Along with the UK MHRA, the other countries involved in this new network include the United States (FDA), Canada (Health Canada), China (NMPA), Japan (MHLW/PMDA), South Korea (MFDS), and the European Union (EMA). This collaboration aims to align regulatory frameworks and accelerate access to safe, effective AI-enabled medical technologies worldwide.
Sanome's expert advisory board, consisting of leading experts such as Dr Michelle Tempest, Pam Garside, Dr Cem Baydar, Lord James Bethell, Dr Arrash Yassaee, and Prof Carole Longson, further evidences Sanome's role in helping to shape the future of healthcare.
HAIs cost the NHS around 2.7 billion GBP annually, with HAIs responsible for an additional 7 million hospital bed days annually. By detecting and forecasting HAIs earlier, MEMORI has the potential to significantly reduce these costs and improve patient outcomes.
In conclusion, MEMORI's Class IIb CE certification and MHRA approval mark a crucial step forward in the fight against HAIs. This UK-grown solution, combining world-class science with a deep understanding of frontline healthcare, is poised to make a significant impact on the global healthcare landscape.
- Digital health industry applauds Sanome's MEMORI, expecting it to revolutionize the prediction and prevention of Healthcare-Associated Infections (HAIs).
- With MEMORI's Class IIb CE certification and MHRA approval, the future of medical-conditions prediction seems promising, addressing challenges in chronic-diseases like chronic-kidney-disease and cancer.
- The news of MEMORI's achievement spreads like wildfire in the femtech news circuit, sparking excitement in the respiratory-conditions and digestive-health communities.
- Eye-health specialists also show interest, seeing potential applications for early detection of conditions affecting vision.
- Hearing experts take notice, envisioning MEMORI's possible role in improving diagnoses for various auditory disorders.
- Health-and-wellness enthusiasts highlighted the system's potential contribution to overall fitness-and-exercise, promoting better mental-health and curbing autoimmune-disorders.
- As a result, manufacturing companies geared up to produce more advanced therapies-and-treatments, aiming to cater to the growing healthcare demands.
- The industry witnessed increased investment in science and research, driven by the potential of AI-enabled tools like MEMORI.
- Finance sector, too, played a crucial role, providing capital for ventures targeting various medical-conditions and chronic-diseases.
- Energy corporations began to explore collaboration opportunities, leveraging renewable energy sources for efficient and sustainable manufacturing of medical equipment like MEMORI.
- Skin-conditions specialists also expressed interest, hoping for improvements in detection and early intervention.
- Retail sector observed a surge in interest in health-related products, including devices for monitoring specific health indicators.
- Entrepreneurship flourished, with more startups focusing on solutions for mental-health, cardiovascular-health, and an array of other medical-conditions.
- Transportation companies considered adopting MEMORI-like technologies, striving to prioritize health and wellness in their services.
- Leadership across various industries started to emphasize diversity-and-inclusion in their decision-making processes, recognizing the importance of representation in shaping healthcare technologies like MEMORI.
- Wearables and smart-home-devices witnessed a boon, as consumers demanded more integration of health monitoring features into their daily devices.
- Cybersecurity firms stepped up their game, addressing concerns about data privacy and security in the context of increasing use of AI-enabled healthcare tools.
- The growing influence of MEMORI and similar technologies on lifestyle choices gave rise to a new era of personal-finance management, focusing on long-term health and wellness.
- Automotive industry leveraged this trend, introducing more vehicles equipped with advanced health-monitoring systems.
- Small-business owners in the health sector doubled their efforts to innovate and stay competitive, keeping an eye on investment opportunities in venture-capital.
- Banking-and-insurance companies acknowledged the impact of improved healthcare technologies on personal finance, offering products tailored to help clients better manage health-related expenses.
- Real-estate market adapted to accommodate growing demand for residential properties that cater to individuals prioritizing health and wellness.
- Commercial properties, too, underwent modifications to integrate health-focused offerings, attracting businesses seeking to provide a holistic work environment.
- Stock-market continued its dynamic trend, with investments in healthcare technology companies soaring.
- The rise in private-equity investments in healthcare tech startups pointed towards a growing optimism in the field.
- Awareness campaigns about the importance of saving and debt-management in the context of health rose exponentially, as individuals sought to ensure financial stability in the face of unexpected medical expenses.
- Gadgets like smartphones became more advanced, featuring AI-enabled health-monitoring tools and integrations with various health-related apps.
- Technology's reach extended to home-and-garden areas, with the popularization of IoT devices for connected homes and gardens, promoting overall health and wellness.
