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. 18, 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. 7, 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. 11, 2021

HistoSonics was chosen as a 2020 Red Herring Top 100 North America Winner. “What has excited me most is to see so many people forging niches in high-tech and cutting edge sectors,” added Alex Vieux, Red Herring’s publisher. “Some of the technical wizardry and first-rate business models showcased at the conference has been fantastic to learn about. We believe HistoSonics embodies the drive, skill and passion on which tech thrives. HistoSonics should be proud of i

Nov. 19, 2020

HistoSonics announced today that it has received approval of an Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA) to begin a clinical trial of its new platform technology, which is designed to use the science of histotripsy to mechanically destroy targeted liver tissue and tumors, from outside of the body. The study is a multi-center, open label and single arm trial to evaluate the safety and efficacy in destroying liver tumors and will build upon the com

Oct. 5, 2020

HistoSonics announced today that it has closed $40 million in an oversubscribed Series C-1 financing.  The round was led by Yonjin Venture, LLC, who specializes in innovative early and mid-stage life science companies, and included additional new strategic investors.  Also participating were existing investors Varian Medical Systems, Inc., Johnson & Johnson Innovation – JJDC, Inc. (JJDC), Venture Investors, Lumira Ventures, State of Wisconsin Investment Board, and o

Jun. 8, 2020

HistoSonics announced today the appointment of Joe Amaral, MD, to the newly created position of Vice President of Medical Affairs, where he will oversee global clinical development initiatives for the company.  Dr. Amaral brings with him more than 35 years of significant clinical and executive leadership in the healthcare space.  Most recently, Dr. Amaral was Global Vice President of Surgical Innovation at Ethicon, Inc. where he developed industry leading hepatobiliary and mi

Jun. 5, 2020