Interventional Systems gets second 510(k) clearance for miniature robot

The FDA cleared the Micromate system to use CT navigation in procedures such as biopsies […]

The FDA cleared the Micromate system to use CT navigation in procedures such as biopsies and ablations.

Dive Brief:

  • Austria-based Interventional Systems said it has picked up a second 510(k) authorization for its table-mounted robotic platform designed for percutaneous procedures.
  • The Food and Drug Administration granted the Micromate system clearance to use computed tomography (CT) optical navigation in procedures such as biopsies and ablations in the chest, abdomen and musculoskeletal structures, the company said Thursday on its website.
  • With its latest FDA clearance, Interventional Systems’ platform is the first needle-based robot for interventional procedures on the U.S. market that is compatible with both fluoroscopy and CT guidance, according to the company. 

Dive Insight:

The field of surgical robotics is becoming increasingly crowded, with startups entering the market to challenge the dominance of pioneer Intuitive Surgical. Companies are looking to compete with smaller and less costly platforms.

Interventional Systems’ robot has been available in the U.S. since 2021 for percutaneous needle interventions with cone-beam computed tomography, fluoro CT or a fluoroscope. It is also cleared for integration into third-party navigation stations. The miniature robotic system allows physicians to use their preferred surgical instruments.

Interventional Systems said its first U.S. installations are in progress.

“This clearance is a long-awaited milestone for us, and it allows us to meet the growing demand for our system in the U.S.,” Pedro Costa, who was named CEO of the company in February, said in a statement. “We expect it to help hospitals gain efficiency in an era where both demand for precision and staff shortages are pressing concerns.”

The company, which is targeting both large institutions and ambulatory centers as potential customers, announced last year it would offer its system on a subscription basis, with a monthly fee and no mandatory service agreements.

The company has also formed a partnership with Johns Hopkins University’s Whiting School of Engineering that it said is aimed at improving the accuracy of robotic-assisted percutaneous procedures and the Micromate system.

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