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+, […]
Dynatronics promotes COO Baker to replace von Jako as CEO | Personnel Moves, August 30, 2019
After deciding this week that its CEO needs to be based in Eagan, Minn., and with chief executive Chris von Jako unwilling to relocate his family, Dynatronics (NSDQ:DYNT) promoted COO Brian Baker to the corner office, effective August 28. “After thoughtful consideration, the board of directors determined that the company’s CEO needs to be based in […]
Ex-Medtronic CFO Ellis joins Inspire Medical board | Personnel Moves, August 2, 2019
Inspire Medical Systems last week named Gary Ellis, the former CFO at Medtronic (NYSE:MDT), to its board of directors effective immediately. Minneapolis-based Inspire Medical also said that Amzak Health managing partner Joyce Erony left the board effective yesterday. Ellis spent 27 years at Medtronic before retiring in 2016. “On behalf of the entire Inspire board […]
Iradimed pulls MRI-safe patient monitor after running afoul of new EU regulations
Iradimed (NSDQ:IRMD) halted sales of its 3880 MRI-compatible vital signs monitor in the European Union, after its CE Mark approval expired last week. Winter Springs, Fla.-based Iradimed said the Jan. 17 expiration came after its notified body, UL International, reviewed its technical file and found that it ran afoul of new EU clinical evaluation rules. UL International […]
Iradimed wins FDA nod for MR-compatible patient monitoring system
iRadimed (NSDQ:IRMD) said today that it won 510(k) clearance from the FDA for its 3880 MR-compatible patient monitoring system. The 3880 device is designed to allow patients to be transported from critical care units for magnetic resonance imaging scans without interruption to vital signs monitoring. Winter Springs, Fla.-based Iradimed claims it as the smallest and most-portable […]
Acelity taps Eckert to succeed Woody as CEO| Personnel Moves | April 5, 2017
Acelity said today it tapped R. Eckert as its new prez & CEO, succeeding Joseph Woody who is stepping away from Acelity following the company’s divestiture of its LifeCell division earlier this year. Eckert previously served as CEO of health information tech company TriZetto Corp, and has led 5 other companies including CRC Health Group, Eclipsys […]
FDA reinstates clearance process for Iradimed’s MR-safe MRidium 3860 infusion pump
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 […]
August 2014 Medical device recalls | Regulatory news for the week of September 8, 2014
Medical device recalls for August 2014
September 3, 2014 by MassDevice
August Summary
Class I recalls: 244
Class II recalls: 171
FDA orders iRadimed to submit new 510(k) after site inspection, stock tanks
iRadimed raises the bar with $12.6M IPO
iRadimed launched its initial public offering today in hopes of raising $12.6 million for its non-magnetic infusion pumps.
The Florida-based device maker is offering just over 2 million shares at $6.25 apiece, as well as an additional 302,400 shares, worth about $1.9 million before underwriting discounts and commissions, to cover potential over-allotments.
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