Insight Medbotics has received 510(k) clearance from the US Food and Drug Administration (FDA) for its magnetic resonance imaging (MRI)-compatible robot, the IGAR system.
The clearance enables the use of the device for breast biopsy indications.
IGAR is claimed to be the first and only robotics system designed to work inside an MRI bore to attain this approval.
The platform has the potential to be customised for upcoming products, allowing them to smoothly transition between diverse healthcare settings, such as moving from an MRI suite to a standard operating room or a physician’s office.
The company has shown the efficacy and safety of this device through published breast biopsy studies.
The technology is also expected to be used to target different organs and disease conditions, deliver therapies and place medical devices.
Insight Medbotics CEO Fazila Seker said: “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.
“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.”
Insight Medbotics is focused on the development of MRI-guided robotics for use in various procedures.