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BioWorld - Friday, June 5, 2026
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Home » Histosonics lands FDA breakthrough device designation
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Histosonics lands FDA breakthrough device designation

Oct. 18, 2021
By Annette Boyle
The FDA granted breakthrough device designation to Histosonics Inc. for the first system to harnesses microbubbles created by pulsed ultrasound waves to wreak very targeted cellular destruction, with real-time visualization and control. The therapy, called histotripsy, destroys tissue in the liver without heat, radiation or surgery. The technology was developed at the University of Michigan.
Medical technology Regulatory Cancer FDA

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