HistoSonics has secured a European CE mark for its histotripsy system Edison, setting the stage for the device’s commercialisation across the continent.
Designed for the non-invasive destruction of liver tumours, HistoSonics’ Edison is an image-guided system that delivers focused ultrasound to target and eliminate cancerous liver tissue. Ahead of its receipt of the CE mark, the device received de novo clearance from the US Food and Drug Administration (FDA) in 2023 for liver tumours. It has also been in controlled early limited market access in the UK under an Unmet Clinical Need Authorisation (UCNA) in May 2025. HistoSonics is the only medtech with a regulatory-cleared histotripsy device, with its founders having developed the technology at the University of Michigan before a spin-out.
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The Minnesota-based company’s European approval was based on clinical data from the #HOPE4LIVER pivotal trial (NCT04573881) that also supported its approval in the US.
The study’s primary efficacy endpoint of complete tumour coverage was achieved in 95.5% of 44 evaluable patients, while the study also demonstrated a local tumour control rate of 90% at 12 months across tumour types treated – a finding HistoSonics said compared favourably to current standard of care (SoC) local regional therapies at one year.
HistoSonics is currently collecting further long-term data to validate the pivotal trial’s findings throughout broader real-world use.
HistoSonics highlighted that its Edison system’s ability to precisely target liver tumours may represent a viable treatment option for patients who are ineligible for surgery or traditional ablation procedures due to tumour location, underlying liver disease, or other clinical factors.
With the CE mark in hand, HistoSonics plans to initiate a phased commercial rollout of Edison across various centres of excellence across Europe that specialise in liver tumour treatment.
HistoSonics’ CEO, Mike Blue, commented: “With the Edison system now approved in Europe, we look forward to working with leading clinical centres throughout the EU and UK to expand access to this non-invasive treatment option, and especially for patients currently suffering from tumours in their liver and who have very few, if any, options.”
The company is also looking at further indications. In May 2026, HistoSonics submitted a de novo application to the FDA seeking authorisation for Edison in treating kidney tumours. The system is also currently under evaluation across pathologies including benign prostatic hyperplasia (BPH), advanced colorectal liver metastasis, and pancreatic adenocarcinoma, as per Clinicaltrials.gov.
In August 2025, HistoSonics, formerly a privately held company, was acquired for $2.25bn by a global investor syndicate co-led by K5 Global, Bezos Expeditions, and Wellington Management.
