HistoSonics announced that its Edison histotripsy system has secured limited market access in the U.K. for noninvasively destroying liver tumors.
The Medicines and Healthcare Products Regulatory Agency in Great Britain granted controlled early limited market access under the U.K.'s Innovative Devices Access Pathway program.
HistoSonics CEO Mike Blue stated that the company is honored to bring histotripsy to patients in the U.K. through this milestone.
The Edison system received de novo clearance from the U.S. FDA in October 2023 and has been adopted by over 50 medical centers in the U.S. for treating over 1,500 patients.