The uncertain times brought on by the COVID-19 pandemic have affected businesses worldwide, and several sectors of medtech industry are projecting hits to their bottom lines. A number of companies have announced decisions to withdraw financial guidance, cut hours and/or staff, among other major business decisions. Initial impacts of the global pandemic on Wall Street […]
Iradimed appoints new VP of regulatory affairs and quality assurance
Iradimed (NSDQ:IRMD) this week said it appointed Steven Kachelmeyer as VP of regulatory affairs and quality assurance, effective March 10. Kachelmeyer will report directly to president and CEO Leslie McDonnell. He replaces Francis Casey who announced his intention to retire, effective June 30. “Under Fran’s leadership, Iradimed gained regulatory approvals in the U.S., Europe and many […]
IRadimed appoints new VP of worldwide sales
Iradimed (NSDQ:IRMD) this week said it appointed MaryBeth Smith as VP of worldwide sales, effective Jan. 20. Smith succeeds Brent Johnson, who is retiring as executive VP of worldwide sales and marketing on April 10. Smith will report directly to president and CEO Leslie McDonnell. “Under Brent’s leadership, Iradimed achieved compound annual sales growth 26% by […]
Iradimed renews CE mark for MRI-safe patient monitor
Iradimed (NSDQ:IRMD) today said it completed the CE mark renewal process and resumed shipments of its patient vital signs monitoring systems. “We are very pleased with obtaining the CE mark renewal certificate for our patient monitors. With the renewed certificate, we are immediately resuming shipments to the impacted customers and thank them for their patience,” president […]
iRadimed clears 5-year-old warning letter
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 […]
