iRadimed (Nasadq:IRMD) issued an urgent medical device correction letter to warn of issues with some infusion pump syringe adapter sets.
The letter notifies customers of a potential issue with some 1057 Syringe Adapter Sets. The issue relates to the syringe venting function during use. This can lead to reduced flow with the MRidium infusion pump, resulting in subsequent inlet occlusion and alarm indication.
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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.
Get the full story at our sister site, Drug Delivery Business News.
Iradimed (Nasdaq:IRMD) shares took a hit this morning despite Street-beating first-quarter results and increased financial guidance.
IRMD shares were down 12.2% at $36.17 per share in early-morning trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — was down 0.1%.
The Winter Springs, Florida-based company posted profits of $2.5 million, or 20¢ per share, on sales of $12.3 million for the three months ended March 31, 2022, for a 79.3% bottom-line gain on sales growth of 33.5%.
Adjusted to exclude one-time items, earnings per share were 22¢, 2¢ ahead of Wall Street, where analysts were looking for sales of $12.2 million.
“I am very satisfied with these results. Having the first quarter start off strongly shows the continued strength of our business. Our growth afforded us the opportunity to pay a special dividend of $1.00 per share during the first quarter,” Iradim…
Iradimed (NSDQ:IRMD) today said it has appointed Chris Scott as chief financial and operating officer, effective immediately.
Scott has served as the Winter Springs, Fla.-based company’s chief financial officer since December 2013. In his new role, Scott will be responsible for providing leadership and oversight in certain operations functions of the MRI-compatible medical device developer company, including customer service, supply chain, manufacturing, regulatory and quality affairs.
The leadership change comes a year after the company’s former president and CEO Leslie McDonnell resigned and Roger Susi took over.