Various tests demonstrated that the main performance characteristics of the device, including radiofrequency emissions and mechanical and electrical safety, met the requisite design specifications, according to Imagin's design partner Optel Inc.
With this development phase finished, Imagin noted that it can now start manufacturing i/Blue on a pilot basis and refine the validation protocols for the device. Some of the units manufactured during the pilot runs will undergo design validation testing. Imagin will submit the resulting data to the U.S. Food and Drug Administration (FDA) as part of the device approval process.
"I couldn't be more pleased about where the company is right now. We're starting off the new year having achieved our 2019 goal of i/Blue units built and verified. These units integrated our innovative design with invaluable feedback from leading urologists at the American Urology Association Meeting last May in Chicago. Now in 2020, we're at a critical point to begin our pilot manufacturing runs and will continue to work with the FDA to determine the final requirements for the i/Blue's market approval.”," Imagin President and CEO Jim Hutchens said in the release.
The company stated that it believes the "i/Blue System, with easy-to-use imaging options, will significantly improve surgeons’ ability to visualize cancerous cells for more accurate resection."
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