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FDA clears world's first MR-compatible robot for breast biopsy removal

por John R. Fischer, Senior Reporter | September 15, 2023
MRI Operating Room Women's Health
Insight Medbotics' Image Guided Automated Robot (IGAR)
The FDA has given the first-ever green light to a robotic placement and guidance system used within an MR bore, one of the most challenging environments for conducting interventional procedures, to perform biopsies for diagnosing breast cancer.

MR-guided breast biopsies are essential for identifying and removing tumors that are not picked up by mammograms and ultrasound. Designed by Insight Medbotics, the Image-Guided Automated Robot (IGAR) is a potentially viable alternative to manual biopsies, which can be challenging in an MR bore due to the confined space, the location and size of lesions, improper targeting, and the scanner’s strong magnetic field.

The solution is mounted to the MR table and aligned with the location of the tumor. Using a remote, the clinician inserts the system's needle into the bore and uses MR imaging as guidance for adjusting its position to accurately target and collect the biopsy.
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In a study published in 2022, IGAR resulted in no adverse events in phase I, and in phase II, patients biopsied reported less pain in one week and less scarring at one-week and one-month intervals. These issues, along with the risk of bleeding, can raise patient anxiety and occasionally lead to the formation of hematomas.

IGAR is also associated with greater comfort and ease-of-use, and could potentially be used to target other organs and disease indications, as well as for therapeutic delivery and device placement, says Insight Medbotics CEO Fazila Seker.

“Many teams are researching viable paths to take robotics into the MR suite, but IGAR is the first to secure FDA clearance,” she said in a statement.

The idea for IGAR was developed by professor Mehran Anvari, a surgical robotics pioneer and the scientific director and CEO of the Centre for Surgical Invention and Innovation (CSii). With his team, he funded preliminary human trials for the solution, and designed its first prototypes with MDA, Canada’s leading space company and the manufacturer of the Canadarm family of space robotics. Together, CSii and MDA launched Insight Medbotics in 2017 in Hamilton, Ontario.

Other partners include McMaster University, where Anvari is the founding director of the Centre for Minimal Access Surgery and the McMaster Institute for Surgical Invention, Innovation, and Education, and St. Joseph’s Healthcare Hamilton.

With 510(k) clearance now secured, Insight Medbotics plans to continue expanding IGAR’s reach in other markets.

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