Imagin Medical (CSE:IME; OTCQB:IMEXF; Frankfurt & Stuttgart Symbol:DPD2) selected Lighthouse Imaging as the contract manufacturer for the i/Blue Imaging System.
Lighthouse is an FDA registered and ISO 13485:2016 certified contract manufacturer that designs, develops, and manufactures state-of-the-art imaging systems for minimally invasive procedures.
“Selecting a contract manufacturer for our i/Blue Imaging System is a major step toward market approval, especially given the significant validation test data the FDA requires as part of the device approval process,” Jim Hutchens, Imagin’s president and CEO, said in a statement.
Lighthouse’s CEO, Tom Snyder, commented, “We understand the rigor required to meet the expectations of the FDA for class III devices and we are excited to work with Imagin to drive the i/Blue system through commercialization.”
