The new clearance enables U.S. marketing for percutaneous procedures using computed tomography (CT) optical navigation. These include biopsies and ablations for diagnosing and treating conditions in the chest, abdomen and musculoskeletal structures.
Interventional Systems said the clearance makes Micromate the first needle-based intervention robot available in the U.S. with compatibility for both fluoroscopy and CT. The system first received clearance as a table-mounted medical robot for interventional procedures in June 2021. The company touted it as the world’s smallest robot for those of the percutaneous kind.
Micromate uses cone-beam computed tomography (CBCT), fluoro CT or a fluoroscope for percutaneous needle intervention. It also received clearance for integration into third-party navigation stations.
Interventional Systems CTO Srdjan Milosavljevic said in a news release that clinical data supporting FDA clearance demonstrated high accuracy in major anatomical regions, “making procedures faster and safer.”
The Austria-based company already started the process of the first installations in the U.S., CEO Pedro Costa said. He called the new FDA clearance “a long-awaited milestone” for the company. Costa expects it to help the company meet growing demand for the system in the U.S.
“We designed Micromate for versatile use within the scope of work of any IR/IO specialist, and we expect it to help hospitals gain efficiency in an era where both demand for precision and staff shortages are pressing concerns,” Costa said.
