Imagin Medical (CSE:IME; OTCQB:IMEXF; Frankfurt & Stuttgart Symbol:DPD2) provided an update on its progress towards verifying the i/Blue imaging system’s functional prototype.
The company has integrated the i/Blue system’s user needs, which were collected, in part, via private focus groups with leading urologists at the recent American Urology Association meeting, into the system’s design specification.
“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,” Jim Hutchens, Imagin’s president and CEO, said in a statement.
Imagin is designing additional functional units for the manufacturing and assembly process, and plans to send some of these functional prototypes to an independent lab to confirm compliance with key medical device regulations and standards.
The company is also preparing for the i/Blue’s initial pilot production run in the third quarter of 2019.
Imagin expects to complete the design verification and device validation stages in fourth quarter of 2019 and the first quarter of 2020, respectively. The company plans to use a portion of the units from its pilot production run for marketing activities, in anticipation of FDA clearance.
“As we continue to progress the technology through the functional phase, we are looking forward to our second meeting with the FDA, currently scheduled for early September, to discuss the i/Blue system’s regulatory path,” Mr. Hutchens added.