May 2026 HistoSonics submitted its Edison Histotripsy System to the U.S. FDA for de novo authorization to treat targeted kidney tumors. The submission expands the company's non-invasive, non-thermal ultrasonic tissue ablation platform beyond liver applications.
November 2025 EDAP TMS received U.S. FDA 510(k) clearance for enhanced Focal One i robotic HIFU system capabilities. The upgrades include advanced ultrasound imaging, streamlined treatment planning, and improved tissue ablation visualization.
October 2025 Addenbrooke's Hospital deployed the Edison Histotripsy System for routine liver tumor treatment under the UK's Unmet Clinical Need Authorisation pathway. The deployment expanded European access to non-invasive ultrasound-based tissue destruction.
July 2025 Insightec received U.S. FDA approval for staged bilateral focused ultrasound treatment for Parkinson's disease. The company planned a limited launch at selected centers, expanding the clinical application of focused ultrasound ablation technology.