Backed by space-age tech, MRI-compatible biopsy robot earns FDA clearance

Image-guided robotic procedures have taken large steps forward in recent years, but one area where they have yet to make inroads is MRI, the tool of choice for scanning soft tissue. The dangers of introducing any extra objects to a strong, fluctuating magnetic field are obvious, and when combined with a cramped working space, the entire prospect poses significant obstacles.

But Insight Medbotics appears to have found a solution. It has secured an FDA clearance for what the company describes as the world’s first surgical robot to operate within the bore of an MRI machine.

The IGAR, or image-guided automated robot, is designed to assist in performing breast biopsies to investigate suspicious lesions for traces of cancer. 

In order to not be tossed around the MRI suite, the system is constructed mostly of plastic and non-ferrous metals—with ceramic materials forming the piezoelectric motors that help align and insert the biopsy tools. At the same time, the device’s copper wiring is routed to prevent any loops that could interact with a magnetic field, while mechanical connections are fashioned out of brass or stainless steel.

With the moving parts built into the patient bed, the machine is powered by a separate, shielded control cart that is kept just out of range of the scanner. IGAR is designed to be compatible with a range of off-the-shelf biopsy tools, syringes and anesthesia needles.

The Ontario-based company was first launched in 2017 as a joint venture between the Centre for Surgical Invention and Innovation and MDA, with funding from the Canadian government. MDA is Canada’s leading space company and famously the designer of the robotic Canadarm used on the space shuttle and International Space Station.

In addition, Insight Medbotics and the CSII have been working with the Canadian Space Agency to develop IGAR’s tele-robotic capabilities, while a deep learning collaboration with IBM was tasked with exploring autonomous technology that would allow IGAR to operate without human intervention.

“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,” Insight Medbotics CEO Fazila Seker said in the company’s announcement. “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 company also said it hopes its technology could one day be adapted for use outside MRI suites, within standard operating rooms and even doctors’ offices, as well as for therapy delivery or device placement.

“FDA clearance brings this technology one crucial step closer to patients,” said CSII’s scientific director and CEO, Mehran Anvari, who also serves as the founding director of the McMaster Institute for Surgical Invention, Innovation and Education. 

“McMaster University and St. Joseph’s Healthcare Hamilton have been significant partners in this journey,” Anvari said. “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.”