Clinical safety and risk management

Tesu Health Ltd, a company incorporated and registered in England and Wales with company number 15275028 whose registered office is at 8A Romsey Terrace, Cambridge, England, CB1 3NH, is a UK-registered medical device manufacturer.

PreDiaWell is a patient-facing digital therapeutic intended to support adults with non-diabetic hyperglycaemia (prediabetes) through structured behavioural modification (e.g. education, goal setting, lifestyle support). The system is delivered primarily via a mobile application and associated cloud services. It provides guidance and programme content and does not provide diagnosis, emergency response, or clinical decision-making.

PreDiaWell is classified as a Class I medical device under the UK Medical Devices Regulations 2002 (UK MDR 2002). Tesu Health’s MHRA account number is 31606. The app was developed by a multidisciplinary team that includes healthcare professionals with extensive experience in clinical practice and health technology and designed following industry standards for medical software, ensuring adherence to regulatory frameworks.

PreDiaWell employs several evidence-based methods for behaviour modification to help users adopt healthier lifestyle habits. The app has been evaluated in a randomised controlled clinical trial (ClinicalTrials.gov ID: NCT05668819), with results published in a peer-reviewed journal (DOI: 10.1177/20552076251376260). The study demonstrated statistically significant improvements in glycaemic control and body weight compared with standard care. No adverse device effects were reported during the trial.

Tesu Health has completed key NHS digital and clinical assurance requirements, including NHS DCB0129 (Clinical Risk Management: Manufacturer), the NHS Data Security and Protection Toolkit (DSPT), and the NHS Digital Technology Assessment Criteria (DTAC). Further details of Tesu Health’s regulatory approvals, certifications, and assurance documentation are available via the Tesu Health Trust Centre.

Clinical risk management and post-market surveillance are overseen by the appointed Clinical Safety Officer. Known and foreseeable risks have been assessed and mitigated as far as possible, and the overall benefit–risk profile is considered acceptable for the intended use and population. The device does not provide automated clinical decision-making and does not replace professional medical judgement.

Users are advised to consult an appropriate healthcare professional regarding diagnosis, treatment, or medication changes.

Clinical Safety Officer: Dr Ilker Tosun – safety@tesuhealth.com

Data Protection Officer: Gürkan Caner Birer – privacy@tesuhealth.com