Iradimed (NSDQ:IRMD) said it doesn’t need to perform any more human factors usability testing to get its bid for 510(k) clearance past the FDA for the MRidium 3860+ MRI-safe IV infusion pump.
The FDA in September 2014 ordered Winter Springs, Fla.-based Iradimed to pursue a new 510(k) clearance for the 3860 version of the MRidium pump, citing the addition of the new iteration’s Dose Error Reduction System.
Today the company said the FDA reinstated its clearance application and gave Iradimed 180 days to change messages displayed on the MRidium 3860 device to clarify whether the DERS function is active and better describe over- and under-range indications.
“We are very pleased with this outcome and now have a clear path to fully resolving this matter. In the coming weeks, we will begin taking the necessary steps of revising the specific messages identified by the agency and revalidate the pump’s software. We anticipate completing this process well before the end of the 180-day period. We are also very pleased with FDA’s conclusion that no additional human factors usability testing is required,” president & CEO Roger Susi said in prepared remarks.
IRMD shares were up 5.6% to $20.20 apiece today in mid-morning trading.