Insight Medbotics Achieves FDA Clearance for Revolutionary MRI-Compatible Robot
Insight Medbotics, a trailblazing medical device company that melds the precision of robotics with the accuracy of MRI technology, has reached a significant milestone. They have secured FDA 510(k) clearance for their innovative IGAR system, an MRI-compatible robot tailored for breast biopsy procedures. Notably, IGAR is now the first and only robotics system to receive regulatory clearance for operation within an MRI bore.
MRI suites present a challenging environment for hospitals due to the strong magnetic fields and the limited space available for physicians to work. This groundbreaking FDA clearance for IGAR opens the door to potential adaptations for future products capable of seamlessly transitioning between various healthcare settings. These transitions could span from an MRI suite to a traditional operating room or even a physician's office.
Insight Medbotics has rigorously demonstrated IGAR's safety and efficacy through published clinical studies focused on breast biopsy procedures. Beyond breast biopsy, this innovative technology holds promise for a wide range of applications, including targeting different organs, addressing various disease indications, and enabling precise therapeutic delivery and device placement.
The development of the IGAR system represents a collaborative effort among world-class experts in surgery and robotics, taking this transformative technology one step closer to enhancing patient care and revolutionizing healthcare practices.