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FDA Clears MRI-Compatible Robotics System for Breast Biopsy
Diagnostic Imaging September 14, 2023
A robotic guidance and placement system, the IGAR system can be utilized inside of a magnetic resonance imaging (MRI) bore.
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...
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