The FDA recently revealed a warning letter it sent to Getinge‘s (PINK:GETI B) Datascope over ongoing issues uncovered during an inspection of its Mahwah, N.J.-based intra-aortic balloon pump production facilities last year, noting a number of continuing quality and validation issues that have not yet been appropriately managed. The federal watchdog said that it has received […]
FDA warns of battery shutdown issues with Getinge’s Maquet/Datascope IABPs
The FDA this week posted a letter to healthcare providers warning of reports that Getinge‘s (PINK:GETI B) Datascope and Maquet intra-aortic balloon pumps are shutting down while running on battery power, which could result in serious injury or death. The company’s intra-aortic balloon pump is designed to be implanted in the descending aorta distal to the left subclavian […]
FDA warns Getinge’s Datascope over IABP production facility issues
The FDA this week released a warning letter it sent to Getinge‘s (PINK:GETI B) Datascope over issues it found during an inspection of its Fairfield, N.J.-based facilities used to manufacture intra-aortic balloon catheters. During the inspection, which took place between March 19 and June 11 this year, the FDA said that it identified five different instances […]
FDA labels IABP recall for Getinge’s Maquet, Datascope as Class I
The FDA today labeled a select recall of Getinge‘s (PINK:GETI B) Datascope and Maquet Cardiosave hybrid intra-aortic balloon pumps over issues related to fluid seepage and corrosion as Class I. A Class I recall is the federal watchdog’s most serious class of recall, indicating the potential for serious injury or death. The Cardiosave hybrid intra-aortic balloon pump is designed […]
FDA updates on Getinge/Datascope IABP recall, labels as Class I
The FDA today updated on Getinge (PINK:GETI B) subsidiaries Datascope and Maquet’s recall of its CS100i, CSO100 and CS300 intra-aortic balloon pumps, initially announced by the company in June, labeling it as a Class I recall. Class I recall designations, the FDA’s most serious classification of recall, are used when there is a reasonable probability that product use […]
Datascope joins Maquet countersuit against Abiomed
Getinge‘s (PINK:GETI B) Datascope said today it is filing a motion to join fellow Getinge company Maquet‘s patent infringement case against Abiomed (NSDQ:ABMD). The Wayne, N.J.-based company said it is asserting counterclaims which allege that Abiomed engaged in false advertising to promote that its Impella device was superior to Datascope’s intra-aortic balloon pumps. Datascope said that, […]
Robots in the OR: Mazor Robotics unveils its latest surgical robot | Regulatory Roundup
Mazor Robotics Ltd. (TASE:MZOR) unveiled its new Renaissance device, the next generation of its spinal robotic surgical guidance systems technology, which extend potential applications to more complex spine surgeries.
The new system is built on the core of the previous generation SpineAssist technology, which has been successfully used in more than 2,000 surgeries worldwide, accurately placing more than 12,000 implants, according to company officials.
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