The company can now commercialize the system in Europe for the treatment of liver tumors.
Plymouth, Minnesota–based HistoSonics designed its Edison platform to use focused ultrasound energy to provide histotripsy for the noninvasive destruction of tumors. Using a robotic arm, Edison mechanically destroys and liquifies targeted tissue and tumors without any incision. It achieves this without the invasiveness or toxicity of traditional procedures.
The platform received its first FDA de novo authorization in the U.S. in 2023 to treat liver tumors. It’s the first and only histotripsy platform cleared for clinical use globally. The company also has Edison under evaluation for benign prostatic hyperplasia (BPH) and kidney tumors.
With CE mark secured, HistoSonics plans to initiate a phased rollout in Europe, starting with select centers specializing in liver tumor treatment.
HistoSonics continues to rack up milestones since it had a majority stake acquired by a syndicate of private and public investors for $2.25 billion in August 2025. It closed an oversubscribed $250 million financing in October 2025, then added more funding last month, bringing its value to $3.75 billion.
Mike Blue, chair and CEO of HistoSonics, said:
“Receiving CE Mark approval marks another historic milestone for HistoSonics and for patients across Europe. Histotripsy represents a fundamentally new way to treat patients, using focused ultrasound to mechanically destroy tumors and tissue without the invasiveness or toxicity of traditional procedures. With the Edison System now approved in Europe, we look forward to working with leading clinical centers throughout the EU and UK to expand access to this non-invasive treatment option, and especially for patients currently suffering from the tumors in their liver and who have very few if any options.”
