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.