Wave Health Now Registered as a Class 1(a) Medical Device in the UK
Treatment Technologies & Insights, Inc. is pleased to announce that Wave Health -- our digital health platform built to support clinicians, patients, and the NHS in the UK -- is now a registered medical device with the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).
This distinction as a UKCA Class I(a) Software as a Medical Device (SaMD) for clinical management support builds on TTI’s compliance with the NHS framework for clinical safety, data protection, technical security and interoperability – including compliance with DCB0129, the NHS standard for clinical risk management.
Wave Health has been evaluated in independent studies and is designed to empower remote, patient-supported symptom monitoring and self-management, while integrating into existing care team workflows to help support capacity while maintaining patient-centered care.
👉 Wave Health is designed to support the priorities set out in the NHS Long Term Plan by Supporting Three Strategic Shifts:
From Analogue to Digital -
✔️ Digitise outpatient care
✔️ Automate workflows / tasks
✔️ Data-driven decisions
From Hospital to Community -
✔️ Ideal for Neighbourhood Health Services, rural areas, and high-volume settings
✔️ Captures critical out-of-clinic context to complement existing data sources
From Treatment to Prevention -
✔️ Identifies emerging adverse events early with the potential to reduce pressure on acute services and avoid hospitalisations.
✔️ Enables more context-rich, personalised patient care
CLINICAL EVIDENCE:
Read the HI Oxford & Thames Valley feasibility study about HCP-perceived usefulness: https://www.wavehealth.app/news/health-innovation-oxford-wave-health-feasibility-study
Learn more about Wave Health’s PRO-WAVE1 feasibility study — presented at ASCO, ISPOR, OPOC and other international congresses, and published in the Real World Data and Digital Oncology Journal (ESMO portfolio), showed:
✔️ 93% patient compliance
✔️ 98% of clinicians rated the platform as useful
🔗 https://www.wavehealth.app/news/wave-health-prowave1-esmo-publication
“The classification as a SaMD reflects Wave Health’s adherence to clinical and regulatory standards” said TTI CEO Matt Lashey. “It also positions Wave Health as a trusted and scalable partner in oncology care, supporting the strategic priorities outlined by the NHS Long Term plan”
This product is owned by TTI. Bayer and TTI have an arrangement under which Bayer has partially funded UK market development work, and Bayer markets the product in the UK on TTI's behalf. This is a standalone product and is not connected with any medicinal products.