The Food and Drug Administration (FDA) recently granted 510(k) clearance for the IGAR system, a groundbreaking robotic guidance and placement system that is specifically designed for use inside magnetic resonance imaging (MRI) machines. Developed by Insight Medbotics, the IGAR system is the first of its kind to gain FDA clearance for use inside the MRI bore, and is specifically indicated for breast biopsy procedures. This regulatory achievement marks a significant milestone in the integration of robotics, artificial intelligence, and MRI imaging, with the potential to greatly improve the quality of life for patients.
Preliminary research on the IGAR system has shown promising results. Patients who underwent biopsies using the IGAR system reported lower pain scores at one week post-procedure, as well as reduced scarring at one week and one month compared to those who underwent manual breast biopsies. These findings highlight the potential benefits of utilizing robotics and advanced imaging technologies in breast biopsy procedures. With the IGAR system, healthcare professionals can enhance accuracy and precision while minimizing patient discomfort and improving cosmetic outcomes.
Fazila Seker, the CEO of Insight Medbotics, expressed excitement over the FDA clearance, stating, “Our team has long believed in the untapped potential of accessible MRI imaging, artificial intelligence, and robotics together to improve the 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.”
As we witness the rapid advancements in medical technology, the IGAR system represents a significant step forward in the field of minimally invasive procedures. With its ability to seamlessly integrate with MRI machines, this robotic guidance and placement system has the potential to revolutionize breast biopsy procedures, providing patients with improved outcomes and a better overall experience.
Sources:
1. Insight Medbotics. Insight Medbotics announces world’s first FDA-cleared, MRI-compatible robot. Cision PR Newswire. Available at: [URL]. 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.