HistoSonics’ Edison System Gains Limited UK Access, While Awaiting CE Marking

CEO Mike Blue Said Histotripsy Will Deliver Clinical Value At A Sustainable Cost For The NHS

While HistoSonics is awaiting the CE mark in Europe, it hit a major milestone by securing early limited market access in Great Britain under a Unmet Clinical Need Authorization (UCNA), bringing its noninvasive histotripsy treatment to patients with liver tumors.

HistoSonics’ Edison histotripsy system received US Food and Drug Administration (FDA) de novo clearance in October 2023 for treating liver tumors.

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