Quantum Surgical’s Epione Robot for Cancer Treatment Receives FDA Clearance

March 22, 2022—Quantum Surgical, a medical robotics company based in Montpelier, France, announced FDA 510(k) clearance for Epione, which the company describes as a new category of interventional oncology robotics dedicated to minimally invasive liver cancer treatment.

According to the company, the FDA 510(k) clearance permits the commercial sale and use of the Epione interventional oncology robot in the United States to facilitate treatment of early stage liver disease. Epione is designed to plan, target, deliver, and confirm percutaneous tumor ablation.

Quantum Surgical advised that this clearance is supported by clinical data from Professor Thierry de Baere, MD, of Gustave Roussy Cancer Center in Villejuif, France, and Professor Boris Guiu, MD, of Montpellier University Hospital in Montpellier, France, whose teams used the Epione system to treat primary and secondary liver tumors.

The company plans to extend indications for the Epione platform to other organs and is developing artificial intelligence–based decision-support features.

“It is tremendous to see Epione now available in the United States as I believe technology like this will have a meaningful impact in the interventional oncology space,” commented Nishita Kothary, MD, in the company’s press release. “Percutaneous tumor ablation is a proven therapy that is underutilized today, and Epione will allow expansion of this minimally invasive treatment to more patients battling liver cancer.” Dr. Kothary is Professor of Radiology at Stanford University Medical Center in Stanford, California.

Professor Steven Colquhoun, MD, a liver transplant surgeon who specializes in robotic surgery at Cedars-Sinai Medical Center in Los Angeles, California, added, “Epione introduces an exciting new era by expanding technical ability and safety in the diagnosis and treatment of lesions anywhere in the liver.”