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Iradimed (Nasadq:IRMD) announced that it voluntarily withdrew an FDA 510(k) application for its new model MR IV pump.

Winter Springs, Florida-based Iradimed said it learned that the FDA likely wouldn’t have time to finish clearance activities for the pending submission. Upon learning this, the company decided to voluntarily withdraw its application on Oct. 5.

The company committed to collaborating with the FDA to better understand the agency’s concerns. Iradimed said the FDA indicated its intent to provide an increased direct dialogue. This would ensure a “timelier clearance” with a replacement filing, according to a news release.

Get the full story at our sister site, Drug Delivery Business News.

Filed Under: Business/Financial News, Drug Pumps, Drug-Device Combinations, Featured, Imaging, MassDevice Earnings Roundup, News Well, Wall Street Beat Tagged With: Iradimed

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