FDA clears new MRI-compatible robot for breast biopsies
Insight Medbotics has gained clearance from the U.S. Food and Drug Administration (FDA) for IGAR, a new robotics system designed to operate within the confines of an MRI bore.
IGAR is the first and only robotics system approved to be used in an MRI scanner. It boasts an adaptable design, allowing for smooth transitions between different healthcare environments.
The safety and efficacy of IGAR for breast biopsies has been substantiated in clinical studies, including one published in August in the National Library of Medicine. However, its potential applications extend beyond breast biopsies to encompass other areas such as delivering medications and placing medical devices.
“Our team has long believed in the untapped potential of accessible MRI imaging, artificial intelligence and robotics together to improve quality of life for patients,” Fazila Seker, CEO of Insight Medbotics, said in a statement. “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.”
The development of IGAR involved a collaborative effort among experts in surgery and robotics. Mehran Anvari, PhD, scientific director and CEO of the Centre for Surgical Invention and Innovation (CSii) and a tenured professor with McMaster University, and his team funded early research and worked with MDA to create and test the earliest prototypes. CSii and MDA went on to launch Insight Medbotics as a startup, receiving additional assistance from Canada's Network of Centres of Excellence program.
“FDA clearance brings this technology one crucial step closer to patients,” Anvari said in the same statement. “McMaster University and St. Joseph’s Healthcare Hamilton have been significant partners in this journey. Their 20-year investment in IGAR’s research concepts, early development, and patents–combined with MDA’s work in space robotics–made it possible to create a robot that operates safely and effectively within the extreme environment of an MRI’s magnetic field.”
With FDA clearance now secured, Insight Medbotics is now working to get the IGAR system into the hands of physicians as quickly as possible.
“Our vision is to build robotics systems that make it easier to provide more targeted care everywhere,” Seker said. “With this milestone, we’re one step closer to making a difference in patients’ lives.”
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