IGAR System Receives FDA Clearance for MRI-guided 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). Developed by Insight Medbotics, the IGAR system is the first of its kind to gain FDA clearance for use inside an MRI bore, specifically for breast biopsy indications.

Preliminary research conducted with the IGAR system has shown promising results. Patients who underwent IGAR biopsies reported lower pain scores at one week post-procedure compared to those who underwent manual breast biopsies. Additionally, the IGAR system demonstrated reduced scarring at both one week and one month follow-up.

The CEO of Insight Medbotics, Fazila Seker, expressed her belief in the potential of combining accessible MRI imaging, artificial intelligence, and robotics to improve patients’ quality of life. She emphasized that while many teams are exploring the integration of robotics into the MRI suite, IGAR is the first system to secure FDA clearance, marking a significant milestone in advancing precision medicine.

The FDA clearance of the IGAR system opens up new possibilities in MRI-guided breast biopsies, offering a more precise and minimally invasive approach. This advancement has the potential to enhance patient comfort, reduce post-procedure complications, and improve overall outcomes. As technology continues to advance, the integration of robotics and AI into medical procedures is expected to play an increasingly important role in revolutionizing healthcare.

Overall, the FDA clearance of the IGAR system represents a significant step forward in the field of MRI-guided procedures. With more research and development, this technology has the potential to benefit not only breast biopsies but also other MRI-guided interventions in the future.

1. Insight Medbotics. Insight Medbotics announces world’s first FDA-cleared, MRI-compatible robot. Cision PR Newswire. Published 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.