Imagin Medical Inc. (IME:CSE; IMEXF:OTCQB) announced in a news release it continues to make progress advancing its i/Blue Imaging System prototype through the seven-step, medical device development process outlined by the U.S. Food and Drug Administration (FDA). It is currently working through the functional phase.
Following i/Blue demonstrations in private focus groups of urologists at the American Urology Association's annual meeting earlier this year, Imagin incorporated their input into the design. "We are pleased with the overwhelmingly positive feedback we received at our recent meetings with urologists, which confirmed that the i/Blue system would be a welcome advancement within their community," President and CEO Jim Hutchens said in the release.
Further, Imagin is designing additional i/Blue functional products for the manufacturing and assembly process. The company will have an independent, external test lab evaluate some of those to ensure they meet all of the necessary requirements and standards, pertaining to electrical safety, electromagnetic emissions, user interface and more.
Imagin has a second meeting with the FDA scheduled for early September to discuss the regulatory path forward for the i/Blue Imaging System.
The company stated that it believes the i/Blue™ Imaging System "will dramatically improve surgeons' ability to visualize cancerous cells by producing higher-quality images more quickly compared with current methods. Based on advanced optics and light sensors, the i/Blue Imaging System employs patented ultrasensitive imaging technology and offers easy-to-use viewing options for more accurate resection." The initial focus is bladder cancer.
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