FDA clears Insight Medbotics’ MRI-compatible surgical robot

The IGAR system. [Image courtesy of Insight Medbotics]Insight Medbotics announced today that it received FDA 510(k) clearance for its IGAR MRI-compatible surgical robot system.

Clearance for the Hamilton, Ontario-based company’s robot applies to breast biopsy indications.

The company said IGAR is the first and only robotic system designed to work inside an MRI bore to garner this regulatory clearance. It features adaptability for future products that could move seamlessly across different care environments. Insight Medbotics says that includes moving from an MRI to a standard operating room or a physician’s office.

IGAR demonstrated its safety and efficacy in published clinical studies for breast biopsies. Other potential applications include targeting other organs and disease indications, as well as therapeutic delivery and device placement.

“Our team has long believed in the untapped potential of accessible MRI imaging, artificial…

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