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 intelligence and robotics together to improve quality of life for patients,” said Fazila Seker, CEO of Insight Medbotics. “Many teams are researching viable paths to take robotics into the MRI suite, but IGAR is the first to secure FDA clearance. This regulatory achievement advances our long-term vision, and our commitment to delivering technology that supports the future of precision medicine.”
More about Insight Medbotics and the IGAR surgical robot
Insight Medbotics said a unique combination of world-class experts in surgery and robotics collaborated to create IGAR. Mehran Anvari, a surgical robotics pioneer, and his team funded the preliminary human trials for IGAR to create and test the first prototypes.
Subsequently, the Centre for Surgical Invention and Innovation (CSii) and MDA launched Insight Medbotics as a startup. CSii and the Canadian Government’s Network of Centres of Excellence program contributed funding to develop IGAR.
The company said that, having secured FDA clearance, it plans to continue advancing IGAR toward the market.
“Our vision is to build robotics systems that make it easier to provide more targeted care everywhere,” said Seker. “With this milestone, we’re one step closer to making a difference in patients’ lives.”
