Cleared for breast biopsy indications, the IGAR system is said to be the first and only robotic guidance and placement system cleared to work inside an MRI bore
Medical device company Insight Medbotics has secured US Food and Drug Administration (FDA) 510(k) clearance for its Magnetic resonance imaging (MRI)-compatible IGAR system.
The IGAR system is said to be the first and only robotic guidance and placement system cleared to work inside an MRI bore.
The FDA has cleared this MRI-compatible robot for breast biopsy.
According to Canada-based Insight Medbotics, the MRI suite is one of the most challenging hospital settings due to the MRI device’s small working space and the use of strong magnetic fields.
The IGAR technology platform can also be used to build future solutions that could smoothly move between various care environments, from an MRI system to a regular operating room or a doctor’s office.
Insight Medbotics has shown the safety and efficacy of the IGAR system through published clinical studies in breast biopsy.
Other potential uses for the technology include focusing on different organs and illness indications, as well as therapeutic delivery and device placement, the medical device firm said.
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.”
The IGAR is the creation of a specialised team of surgeons and robotics professionals. It was supported by Mehran Anvari, CEO and scientific director of the Centre for Surgical Invention and Innovation (CSii).
IGAR’s initial human trials were funded by his team, and the device’s first prototypes were built and tested in partnership with MDA, a Canada-based space firm.
Insight Medbotics was established by CSii and MDA as a start-up business. The company also got sizeable financing from CSii and the Network of Centres of Excellence (NCE) initiative of the Canadian Government.