The histotripsy process. | Supply: Screenshot taken from a HistoSonics video
HistoSonics introduced final week that its Edison histotripsy system for noninvasively destroying liver tumors has secured restricted U.Okay. market entry.
In accordance with the Plymouth, Minn.–primarily based firm, the Medicines and Healthcare Merchandise Regulatory Company in Nice Britain granted managed early restricted market entry below an Unmet Medical Want Authorisation accessible via the U.Okay.’s Progressive Units Entry Pathway (IDAP) program.
The Edison system was one in every of simply eight accessible utility spots in 2024, HistoSonics stated.
“Securing GB-controlled entry via the IDAP pilot program is an incredible milestone for HistoSonics and alerts clear recognition of our know-how’s potential to rework healthcare,” acknowledged HistoSonics CEO Mike Blue. “We’re honored to work alongside the NHS and U.Okay. regulatory and entry companions to deliver histotripsy to sufferers throughout the U.Okay., a lot of whom have restricted choices. This progress builds on our robust scientific monitor report within the U.S. and our rising base of scientific proof globally.”
The Monetary Occasions reported final month that HistoSonics is contemplating a possible sale after receiving a number of presents from main medical know-how corporations.
Edison makes use of ultrasound power to focus on tumors
The Edison system makes use of centered ultrasound power to supply histotripsy remedy. Delivered by way of a robotic arm, the non-thermal, non-invasive centered ultrasound know-how mechanically destroys and liquifies focused tissue and tumors, with out the invasiveness or toxicity of conventional procedures.
HistoSonics famous that physicians who’ve accomplished firm-provided coaching ought to solely use the system. The scientific judgment of a certified and appropriately educated doctor ought to at all times information its use, it added.
Edison acquired de novo clearance from the U.S. Meals & Drug Administration in October 2023.
HistoSonics will get first insurance coverage protection
Additionally final month, HistoSonics secured its first main insurance coverage protection for Histotripsy. Blue Cross Blue Defend of Michigan (BCBSM) and Blue Care Community created a brand new medical coverage for histotripsy of the liver. The coverage covers non-thermal histotripsy utilizing the Edison Histotripsy System for the remedy of main and metastatic liver tumors.
This implies, as of Feb. 1, 2025, histotripsy is a reimbursable process for the non-invasive mechanical destruction of liver tumors below CPT code 0686T. This provides eligible sufferers in Michigan early entry to this incisionless remedy forward of the broader coverage’s efficient date of July 1.
Up to now, greater than 50 main medical facilities throughout the U.S. have adopted the Edison Histotripsy System. Surgeons, radiologists, and oncologists have used it to deal with over 1,500 sufferers, claimed HistoSonics.
Editor’s word: This text was syndicated from The Robotic Report sibling web site MassDevice.
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