06:43:45 EDT Tue 23 Apr 2024
Enter Symbol
or Name
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CA



Imagin Medical Inc
Symbol IME
Shares Issued 139,060,278
Close 2019-09-24 C$ 0.055
Market Cap C$ 7,648,315
Recent Sedar Documents

Imagin Medical meets with FDA re i/Blue pathway

2019-09-26 08:56 ET - News Release

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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