HistoSonics Gets Breakthrough Device Designation for Sonic Beam Cancer Therapy

Minneapolis, Minn.-based HistoSonics’ noninvasive sonic beam device for delivering liver cancer therapy has been granted a Breakthrough Device designation by the FDA.

The beam therapy uses acoustic energy to mechanically destroy and liquefy tissue in the liver without incisions, ionizing radiation or heat.

A study is under way under an Investigational Device Exemption to evaluate the safety and efficacy of the sonic beam treatment in patients with liver tumors, the company said.