Noninvasive tumor treatment options for liver cancer are expanding in the United Kingdom following recent regulatory steps by HistoSonics. The company’s Edison histotripsy system, which employs focused ultrasound to mechanically destroy liver tumors without surgery, has been approved for limited early market access through a special U.K. program. This progression not only marks an advancement for HistoSonics but also introduces patients and clinicians in the region to additional therapeutic possibilities besides conventional interventions. Patients dealing with liver tumors may now have an alternative where surgical risk is high or traditional options are limited.
Regulatory bodies in the U.K. granted Edison’s entry via the Innovative Devices Access Pathway (IDAP), under the Unmet Clinical Need Authorisation. This system’s entry was one of only eight slots available in 2024, making its selection notable for the region’s medical technology landscape. When the Edison device previously gained de novo clearance from the U.S. FDA in October 2023, discussion in industry circles centered on its nonthermal, noninvasive approach. Until this U.K. approval, its utilization was mostly confined to clinical settings within the U.S., where early users provided clinical feedback and helped develop evidence for its safety and efficacy. More recently, media coverage highlighted rumors around HistoSonics’ acquisition talks involving leading medical technology enterprises, underlining the increased interest in focused ultrasound applications, though no confirmed deal was reported as of yet.
What Distinguishes the Edison Histotripsy System?
The Edison system delivers histotripsy treatment by harnessing focused ultrasound energy, which is uniquely mechanical rather than thermal in effect. Guided by a robotic arm, the technology destroys and liquefies cancerous tissue in the liver without requiring incisions or exposing patients to the toxicity typical of chemotherapy or radiation. Clinical use is limited to physicians who have completed specific training from HistoSonics, ensuring standardized procedures across different care settings.
What Access and Coverage Does the Device Receive?
“We are honored to work alongside the NHS and U.K. regulatory and access partners to bring histotripsy to patients across the U.K., many of whom have limited options. This progress builds on our strong clinical track record in the U.S. and our growing base of clinical evidence globally,” said HistoSonics CEO Mike Blue.
Recent months have seen increased support for the Edison system beyond regulatory clearance. Notably, Blue Cross Blue Shield of Michigan and Blue Care Network established medical coverage of nonthermal histotripsy using the Edison system, thus allowing reimbursement for the mechanical destruction of liver tumors as of February 2025. This represents a formal recognition of the procedure’s potential value for eligible patients in the United States, ahead of broader coverage set to begin in July.
How Widely Has Edison Been Adopted by Medical Centers?
The Edison Histotripsy System’s deployment has expanded to more than 50 major medical institutions in the U.S., where it has been used to treat over 1,500 patients according to company figures. Surgeons, radiologists, and oncologists have integrated Edison into various care strategies for both primary and metastatic liver tumors, contributing to a growing pool of clinical data and user experience.
Wider adoption and insurance coverage for focused ultrasound-based therapies such as Edison signal a gradual shift towards noninvasive solutions where possible. Before using such a system, both patients and clinicians must consider the specifics of tumor location, existing health conditions, and the expertise required for operation. As clinical evidence accumulates and coverage expands, medical professionals are likely to compare focused ultrasound to established surgical, ablative, or pharmacological options. For patients seeking alternatives to conventional liver tumor treatments, understanding new device-based approaches—including their candidacy, process, and known outcomes—can help them make informed decisions. Staying updated on new approvals, insurance arrangements, and potential acquisition moves among technology providers may offer patients insight into the evolving landscape of cancer care devices.
