Imagin Medical (CSE:IME; OTCQB:IMEXF; Frankfurt & Stuttgart Symbol:DPD2) recently met with the FDA to discuss its premarket approval regulatory pathway for marketing authorization of its i/Blue Imaging System.
Based on the company’s continued discussions with the agency, Imagin anticipates pursing approval for i/Blue through a regulatory pathway that demonstrates safety and effectiveness but that is also the least burdensome approach for the company.
The initial i/Blue functional products, along with the necessary documentation to support them, are on schedule to be verified in late 2019.
“We are pleased with the feedback we received from the FDA during our second meeting to discuss i/Blue’s regulatory path,” Jim Hutchens, president and CEO, said in a statement. “We will continue to collaborate with the agency as we move closer to our submission package.”