FDA Clears MRI-Compatible Robotics System for Breast Biopsy

The Food and Drug Administration (FDA) has granted 510(k) clearance for the IGAR system, a robotic guidance and placement system that is compatible with magnetic resonance imaging (MRI).

Insight Medbotics, the developer of the IGAR system, noted the robotics system is the first to gain FDA clearance for use inside of an MRI bore, and is cleared for breast biopsy indications.¹

Preliminary research with IGAR biopsies resulted in lower pain scores at one week as well as reduced scarring at one week and one month in comparison to manual breast biopsies.²

“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,” noted Fazila Seker, the 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.”

References

1. Insight Medbotics. Insight Medbotics announces world’s first FDA-cleared, MRI-compatible robot. Cision PR Newswire. Available at: https://www.prnewswire.com/news-releases/insight-medbotics-announces-worlds-first-fda-cleared-mri-compatible-robot-301925289.html . Published September 13, 2023. Accessed September 13, 2023.

2. Anvari M, Chapman T, Barlow K, Cookson T, Van Toen C, Fielding T. Clinical safety and efficacy of a fully automated robot for magnetic resonance imaging-guided breast biopsy. Int J Med Robot. 2023;19(2):e2472. doi: 10.1002/rcs.2472.