Plymouth, Minnesota–based HistoSonics seeks authorization to bring the Edison system to market for the destruction of kidney (renal) tumors.
The Edison platform uses focused ultrasound energy to provide histotripsy for the noninvasive destruction of tumors. Using a robotic arm, Edison mechanically destroys and liquifies targeted tissue and tumors without any incision. It achieves this without the invasiveness or toxicity of traditional procedures. The platform received its first FDA de novo authorization in the U.S. in 2023 to treat liver tumors. It’s the first and only histotripsy platform cleared for clinical use globally. The company also has Edison under evaluation for benign prostatic hyperplasia (BPH).
At DeviceTalks Minnesota last week, HistoSonics CEO Mike Blue explained how the company — a majority of which was acquired by an investor syndicate for more than $2 billion last year — has built a platform that can expand into a wide variety of indications: “We will be submitting at the end of the summer for our pancreatic tumor indication, and we’ve just [gone] back to treating patients in BPH, and with the funding from last year, use of proceeds will go towards thyroid, breast, uterine fibroids, bladder, spine, and we will commercialize the nervous system.”
For more medtech industry insights — including more about incisionless surgery from another company in the space, Petal Surgical — register for DeviceTalks Boston, May 27–28, 2026.
HistoSonics said its submission includes clinical evidence from its ongoing #HOPE4KIDNEY trial of 67 patients. The company said the trial continues to generate “promising insights” into the potential of histotripsy in kidney applications.
Dr. William Huang, urologic oncologist at NYU Langone Health, serves as #HOPE4KIDNEY principal investigator. Huang said the study demonstrated “precise, noninvasive tumor destruction without incisions, radiation, or thermal injury.”
“This submission is an important milestone in expanding histotripsy beyond the liver and into the kidney, an area where patients and physicians are seeking organ-preserving and nephron-sparing alternatives,” said Mike Blue, chair and CEO of HistoSonics. “We believe histotripsy has the potential to fundamentally change how solid tumors are treated, delivering precise, non-invasive therapy that preserves what matters most – including patient quality of life.”
Editor-in-chief Chris Newmarker contributed to this report.
