Sam Brusco, Associate Editor09.13.23
Insight Medbotics has gained U.S. Food and Drug Administration (FDA) 510(k) clearance for its IGAR MRI-compatible surgical robot. The clearance covers breast biopsy indications.
According to the company, IGAR is the first, only robotics system designed to work inside an MRI bore to gain this regulatory clearance. Insight Medbotics also said IGAR may be adapted for future products that could move from MRI to a standard operating room, or into a physician’s office.
IGAR’s safety and efficacy was demonstrated through publication of clinical studies in breast biopsy. The company said other potential applications could include targeting other organs and disease indications, 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," Fazila Seker, CEO of Insight Medbotics told the press. "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."
IGAR is the brainchild of experts in surgery and robotics, and Insight Medbotics was launched at a startup by the Centre of Surgical Invention and Innovation (CSii) and MDA—Canada’s leading space company—who designed and manufactured the Canadarm family of space robotics.
Insight Medbotics said it will continue to advance IGAR into market.
According to the company, IGAR is the first, only robotics system designed to work inside an MRI bore to gain this regulatory clearance. Insight Medbotics also said IGAR may be adapted for future products that could move from MRI to a standard operating room, or into a physician’s office.
IGAR’s safety and efficacy was demonstrated through publication of clinical studies in breast biopsy. The company said other potential applications could include targeting other organs and disease indications, 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," Fazila Seker, CEO of Insight Medbotics told the press. "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."
IGAR is the brainchild of experts in surgery and robotics, and Insight Medbotics was launched at a startup by the Centre of Surgical Invention and Innovation (CSii) and MDA—Canada’s leading space company—who designed and manufactured the Canadarm family of space robotics.
Insight Medbotics said it will continue to advance IGAR into market.