Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, if he will make an assessment of the effectiveness of histotripsy treatment in the NHS.

Early clinical evidence shows that histotripsy, a non-invasive focused ultrasound treatment, can safely and precisely destroy liver tumours without the need for surgery or radiation. Histotripsy remains under evaluation, and the Government continues to monitor real-world outcomes, including its effectiveness in the National Health Service. The Government is working with clinical and research experts to accelerate United Kingdom-based evidence generation to support wider NHS adoption of histotripsy.

HistoSonics developed the Edison System to delivery histotripsy, and this was selected as one of eight transformative technologies supported through the Government’s Innovative Devices Access Pathway (IDAP) pilot, which streamlines patient access to medical devices addressing unmet clinical needs in the NHS.

Through the IDAP, the Medicines and Healthcare products Regulatory Agency (MHRA) granted HistoSonics an Unmet Clinical Need Authorisation (UCNA), exempting the manufacturer from certain regulatory requirements under strict conditions, allowing early market access. This authorisation is reserved for technologies that address a critical unmet clinical need and demonstrate sufficient data for safety and early effectiveness, with evidence that the manufacturer is working towards full regulatory approval. The UCNA requires ongoing reporting to the MHRA to monitor safety and performance.