HistoSonics logo

News

HistoSonics Edison System Recognized with BioTech Breakthrough Award for "MedTech Innovation of the Year"

Annual Awards Program Recognizes Innovation in the Global Life Sciences and Biotechnology Industry LOS ANGELES, Nov. 08, 2023 (GLOBE NEWSWIRE) -- BioTech Breakthrough, a leading independent market intelligence organization that evaluates and recognizes standout life sciences and biotechnology companies, products and services around the globe today announced that HistoSonics®, the manufacturer of the recently FDA cleared […]
Read More

HistoSonics Notches Significant Reimbursement Wins

HistoSonics Notches Significant Reimbursement Wins MINNEAPOLIS--(BUSINESS WIRE)--HistoSonics, (www.histosonics.com), the manufacturer of the non-invasive Edison® Histotripsy System and novel sonic beam therapy, announced today that the Centers of Medicare & Medicaid Services (CMS) set a new payment rate for histotripsy of liver tumors procedures, increasing the payment rate to $17,500. In their November 2023 rule making […]
Read More

FDA Awards HistoSonics Clearance of its First-of-a-Kind Edison® Histotripsy System

Company Ramping Up Launch Plans of its “Breakthrough Device” Designated Platform Minneapolis, MN. October 9th, 2023 – HistoSonics®, (www.histosonics.com), the manufacturer of the Edison® System and novel histotripsy therapy platforms, announced today the marketing authorization of its “Breakthrough” platform via the U.S. Food and Drug Administration's (FDA) De Novo Classification Request process, a rigorous pre-market […]
Read More
Scans showing internal tumors

HistoSonics Announces First Ever Kidney Tumor Treatment Using Histotripsy

HistoSonics announced today the first kidney patient has been treated using the Company’s histotripsy platform. The procedure was performed in Leeds, UK, by Professor Tze Min Wah, Senior Consultant Radiologist and Clinical Lead for Interventional Oncology Program at Leeds Teaching Hospitals NHS Trust, UK. This procedure marks the initial treatment in the HistoSonics sponsored “CAIN” Trial which is a […]
Read More
HistoSonics technology targeting kidney tissue to be destroyed

HistoSonics Announces FDA Approval of its Pivotal IDE #HOPE4KIDNEY Trial

HistoSonics announced today the US Food and Drug Administration (FDA) has approved the company sponsored #HOPE4KIDNEY Trial which is designed to evaluate the safety and technical success of the Edison System in targeting and destroying targeted primary renal tumors, completely non-invasively and without the need for incisions or needles. FDA approval of the #HOPE4KIDNEY IDE […]
Read More
HistoSonics, non-ionizing, non-invasive, non-thermal

HistoSonics Announces Published Results of Phase I Liver Tumor Trial

HistoSonics announced today the publication of results from their prospective Phase I clinical trial, named the THERESA Trial, conducted in Barcelona, Spain. The study reported results on eleven targeted tumors in the eight patients treated who all had unresectable end-stage multifocal liver tumors: colorectal liver metastases (CRLM) in 5 patients (7 tumors), breast cancer metastases in […]
Read More
A close-up of the HistoSonics transducer

HistoSonics Receives FDA “Breakthrough Device Designation” for Novel Sonic Beam Therapy

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 […]
Read More
The HistoSonics system targeting a tumor

HistoSonics Announces Milestone As AMA Issues Unique Category III CPT® Code For Histotripsy Of Liver

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 […]
Read More
A close up on the HistoSonics device

HistoSonics Announces First Patient Treated in European Clinical Trial

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 […]
Read More
The HistoSonics team celebrating their 1st patient treated

HistoSonics Announces First Patient Treated in US Clinical Study of Novel Sonic Beam Therapy for Liver Tumors

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 […]
Read More
1 2

Last updated on November 8, 2023

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

The Edison® System is intended for the non-invasive mechanical destruction of liver tumors, including the partial or complete destruction of unresectable liver tumors via histotripsy. The FDA has not evaluated the Edison System for the treatment of any disease including, but not limited to, cancer or evaluated any specific cancer outcomes (such as local tumor progression, 5-year survival or overall survival). The System should only be used by persons who have completed training performed by HistoSonics, and its use guided by the clinical judgment of an appropriately trained physician. Refer to the device Instructions for Use for a complete list of warnings, precautions and a summary of clinical trial results, including reported adverse events.

Footer last updated on October 11, 2023
X New Twitter Logo
© 2019-2023 HistoSonics®. All rights reserved.
Website Powered by Brandography