MRI accessories developer IRadimed has finally put an August 2014 warning letter from the U.S. Food and Drug Administration (FDA) behind it.
The company said it received a closeout letter from the FDA stating that all issues in the warning letter have been resolved. In the 2014 warning letter, the FDA requested that IRadimed immediately cease distribution of certain MRI infusion pumps and submit a new 510(k) application.
IRadimed said it does not expect the closeout to have a significant effect on its business or financial performance.
