iRadimed (NSDQ:IRMD) last week finally cleared a five-year-old warning letter from the FDA issued over quality issues with its IV infusion pumps.
The August 2014 warning letter chided Winter Springs, Fla.-based Iradimed for its complaint handling and ordered it to seek a new 510(k) clearance for software upgrades to one of the pumps, the mRidium 3860+, ordering the company to pull the device from the market. Iradimed won a new clearance for mRidium 3860+ in December 2016.
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