Digital Health Coffee Time Briefing ☕

Your morning summary of digital health news, information and events to know about if you want to be “in the know”. 

???? News   

???? The media team at the MHRA, in collaboration with the FDA and Health Canada, has published five guiding principles for the development of predetermined change control plans (PCCPs) for developers of machine-learning-enabled medical devices (MLMDs). These guiding principles aim to support manufacturers of MLMDs by reducing the regulatory burden of reassessment following changes and updates to their devices. This will also allow reallocation of resources to improve product performance for patients. 

???? FuturU, a new edtech startup providing free learning to healthcare professionals, has developed an industry-first AI motion capture tool that teaches and assesses moving and handling skills. Called Captain, the tool allows healthcare professionals to safely practise moving and handling techniques in a virtual environment using an online mannequin. Accessed through a smartphone or laptop, the programme can accurately track a user’s physical movements to see whether they are safely moving someone from a seated to a standing position. The motion capture tool uses AI to identify the correct movement based on a person’s shape and size, the patient they are moving and the environment they are in. 

✅ Lucida Medical Ltd, a Cambridge-based start-up company dedicated to improving cancer diagnosis, has announced it has received Class IIb CE certification for its AI-based prostate cancer detection software, Prostate Intelligence (Pi). Built in partnership with leading clinicians and UK NHS hospitals, the CE mark means the software can now benefit patients across the UK and European healthcare systems. Using AI, Pi analyses the MRI and is fully integrated into the radiologist’s workflow, targeting key issues of variability, radiologist time, and diagnostic accuracy in prostate cancer. 

???? Leiden University Medical Center (The Netherlands) has expanded cooperation with AI medical imaging company Oxipit by deploying the latest Oxipit product – AI quality assurance tool for CT Pulmonary Embolism (PE). The LUMC deployment was facilitated through the radiology imaging solution by Sectra and its integration capabilities. LUMC is already using the full suite of Oxipit AI products, including quality assurance tools for other modalities and the first autonomous AI imaging application ChestLink. 

⏳ Applications are now open for the Topol Digital Fellowship, which provides health and social care professionals with time, support and training to lead digital health transformations and innovations in their organisations. All applicants must be working in a role where they have the ability to focus on a digital transformation or innovation project. Find out more and apply here. 

❓ Did you know that? 

Mass General presented data from a large real-world evidence study (800+ patients over 2 years) investigating the impact of Manha’s digital therapeutic on reducing the severity of IBS symptoms. Presented at the American College of Gastroenterology (ACG) meeting in Vancouver, use of the digital IBS therapeutic showed: 

• 60% of users reported a reduction in the severity of IBS symptoms. 
• Reduced stress 
• Nearly 40% adherence to the program in a condition where medication adherence is a common challenge. 

???? What we’re reading 

Abott – Can Health Tech Be the Most Helpful Technology Of All? 

???? This week’s events 

25-28 October, in London, Wandsworth Halloween Beer & Cider Festival 2023 

26 October, in London, Healthtech Entrepreneurship Panel 

27 October, in London, International Conference on Telerobotic Surgery and Surgery Procedures (ICTSSP)