HistoSonics Awarded Key Position in UK’s Novel Innovation Program

February 14, 2024

Edison Histotripsy System Selected for Competitive Accelerated Market Access Program Minneapolis, MN. February 14th , 2024 – HistoSonics ® , (, the manufacturer of the Edison ® System and novel histotripsy therapy platforms, announced today that the company’s Edison System has been selected to participate in the UK’s newly created Innovative Devices Access Pathway (IDAP) […]
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World’s First Kidney Tumor Treated Using the HistoSonics’ Edison® Histotripsy System

January 9, 2024

AdventHealth Celebration (FL.) Urology Performs Non-Invasive Histotripsy in Patient with Primary Solid Renal Tumor   Minneapolis, January 10, 2024 – HistoSonics, Inc., (, developer of a non-invasive platform and novel sonic beam therapy called histotripsy, announced today the treatment of the first patient in its pivotal #HOPE4KIDNEY Trial. The FDA approved the investigational device study […]
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Histotripsy Cancer Treatment

World’s First Patients Treated With Novel Edison® Histotripsy System

January 5, 2024

MINNEAPOLIS--(BUSINESS WIRE)--HistoSonics, (, the manufacturer of the non-invasive Edison® Histotripsy System, announced today a patient from the University of Rochester Medical Center has received the world’s first targeted liver tumor treatments utilizing the Edison System following its recent FDA De Novo clearance. In the same week Cleveland Clinic treated their initial patients suffering from liver […]
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HistoSonics Edison System Recognized with BioTech Breakthrough Award for "MedTech Innovation of the Year"

November 8, 2023

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 […]
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HistoSonics Notches Significant Reimbursement Wins

November 6, 2023

HistoSonics Notches Significant Reimbursement Wins MINNEAPOLIS--(BUSINESS WIRE)--HistoSonics, (, 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 […]
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FDA Awards HistoSonics Clearance of its First-of-a-Kind Edison® Histotripsy System

October 9, 2023

Company Ramping Up Launch Plans of its “Breakthrough Device” Designated Platform Minneapolis, MN. October 9th, 2023 – HistoSonics®, (, 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 […]
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Scans showing internal tumors

HistoSonics Announces First Ever Kidney Tumor Treatment Using Histotripsy

May 30, 2023

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 […]
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HistoSonics technology targeting kidney tissue to be destroyed

HistoSonics Announces FDA Approval of its Pivotal IDE #HOPE4KIDNEY Trial

February 13, 2023

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 […]
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HistoSonics, non-ionizing, non-invasive, non-thermal

HistoSonics Announces Published Results of Phase I Liver Tumor Trial

September 19, 2022

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 […]
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A close-up of the HistoSonics transducer

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

October 18, 2021

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 […]
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Last updated on February 14, 2024

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.

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