HistoSonics
9 News & Press Releases found

HistoSonics news

HistoSonics announced today that the U.S. Food and Drug Administration (FDA) has granted the company Breakthrough Device Designation for its new therapy platform. Histotripsy of the liver provides clinicians the first automated external beam therapy using acoustic energy to mechanically destroy and liquefy tissue in the liver without incisions, ionizing radiation or heat.

“The Breakthrough Device Designation is a significant milestone for our company and validates ou

Oct. 17, 2021

HistoSonics is pleased to announce that the American Medical Association (AMA) has issued a new Current Procedural Terminology (CPT) code for histotripsy of the liver. Histotripsy of the liver provides clinicians the first automated external beam therapy using acoustic energy to mechanically destroy tissue in the liver without incisions, ionizing radiation or heat. The new CPT code will become effective on January 1, 2022, at which time providers can utilize the code when performing hist

Jul. 12, 2021

HistoSonics announced today that the first patient has been treated as part of the company’s #HOPE4LIVER Europe Trial, which was approved by German authorities earlier in the year.  The study is designed to evaluate the safety and efficacy of the HistoSonics’ platform technology, which uses the novel science of histotripsy and the mechanical properties of therapeutic focused ultrasound, to destroy unwanted tissue, including targeted primary and metastatic liver tumors,

Jun. 6, 2021

HistoSonics announced today the treatment of the first patient in the #HOPE4LIVER US Study.  The investigational device study was approved by the FDA in the fourth quarter of 2020. The study is designed to evaluate the safety and efficacy of the company’s platform technology, which uses the novel science of histotripsy, a form of therapeutic focused ultrasound, to mechanically destroy targeted primary and metastatic liver tumors, without invasive incisions or needles enterin

Feb. 3, 2021

HistoSonics announced today that it has received approval to initiate the company’s second European clinical trial of its new platform technology, which is designed to use the science of histotripsy to mechanically destroy targeted liver tumors, from outside of the body. The study, similar to HistoSonics’ recent FDA approved #HOPE4LIVER U.S. Study, is a multi-center, open label, single arm trial to evaluate the safety and efficacy in destroying liver tumors and will build u

Jan. 10, 2021