Mr. Jim Hutchens reports
IMAGIN MEDICAL ANNOUNCES MEETING REGARDING I/BLUE'S REGULATORY PATHWAY
Imagin Medical Inc. recently met with the U.S. Food and Drug Administration to discuss its premarket approval regulatory pathway for marketing authorization.
Based on the company's continued collaborative discussions with the Agency, Imagin anticipates pursing approval for the i/Blue imaging system 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 late this year.
"We are pleased with the feedback we received from the FDA during our second meeting to discuss i/Blue's regulatory path," said Jim Hutchens, Imagin's president and chief executive officer. "We will continue to collaborate with the Agency as we move closer to our submission package."
About Imagin Medical Inc.
Imagin Medical is a surgical imaging company focused on establishing a new standard of care in visualizing cancer during minimally invasive surgeries (MIS).
We seek Safe Harbor.
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