Imagin Medical (CSE:IME; OTCQB:IMEXF) is making progress towards design verification of its i/Blue Imaging System functional product.
The company has purchased and received components from established suppliers to meet its custom specifications for the initial build of i/Blue functional units.
Currently, components are being assembled for the control unit, which will integrate the dual wavelength light source with the dual camera handpiece, allowing simultaneous streaming of white light and blue light images to be projected side-by-side on the display monitor.
The i/Blue Imaging System consists of a controller that houses the light and energy sources; dual camera handpiece; optical light cables; medical-grade equipment cart; and medical-grade printer. The system is used with a third-party cystoscope.
i/Blue is designed to dramatically improve physicians’ ability to visualize cancerous cells. Working in conjunction with fluorescing imaging agents, this advanced, ultrasensitive imaging technology combines sophisticated opto-electronic functions and near-infrared fluorescence to deliver images far superior to conventional white light systems. High-definition images that highlight not only cancerous cells above the bladder wall, but also pre-malignant lesions, flat tumors and tumor tissue along the margins will produce more successful surgical outcomes.
In a statement, Jim Hutchens, president and CEO, said the functional units are on schedule for design verification, leading the way to pilot production runs. “Throughout this process, we continue to work with the FDA to determine the final requirements for obtaining marketing clearance.”
He said in-depth evaluation of the system will be performed by an independent testing lab to confirm electrical safety, radiated emission and susceptibility compliance, as well as other requirements.
Data from these independent lab tests will be combined with data from internal testing performed by Imagin’s opto-electronic design firm, Optel, engineering calculations, component suppliers and competitive device analysis, all of which will become the basis of the company’s verification report, he added.
As previously announced, Imagin expects this work will be in process prior to the end of 2019.