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 […]
Getinge touts results from IABP study in MI patients with persistent ischemia
Getinge (PINK:GETI B) late last week released results from a pilot study of its intra-aortic balloon pump exploring its use with patients with extensive myocardial infarction complicated by persistent ischemia following primary percutaneous coronary interventions. Results from the pilot study were presented by co-principal investigator Dr. Lokien van Nunen of Eindoven, The Netherlands’ Catharina Hospital at the […]
7 medtech stories we missed this week: March 2, 2018
From InspireMD’s new distribution deals to Kelynium’s distribution deal with a mystery partner, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. InspireMD inks distribution deals in Greece, Caribbean InspireMD announced in a March 1 press release that it has signed exclusive distribution agreements with T-Vascular IKE Medical Supplies […]
FDA clears FloPump 32 from International Biophysics
International Biophysics said today that it won 510(k) clearance from the FDA for its FloPump 32 centrifugal disposable heart pump, designed for use with Getinge (PINK:GETI B) subsidiary Maquet Cardiovascular‘s RotaFlow console. Austin, Texas-based International Biophysics tout The FloPump 32 as one of the smallest centrifugal pumps in the world at 32ml prime. “With this FDA clearance of […]
Maquet opens a new front in patent war with Abiomed
Getinge (PINK:GETI B) subsidiary Maquet opened a new front last week in its patent war with Abiomed (NSDQ:ABMD), alleging infringement of a patent granted earlier this year. Danvers, Mass.-based Abiomed sued Maquet in May 2016, asking Judge Dennis Saylor of the U.S. District Court for Massachusetts for a judgment of non-infringement of a trio of patents; […]
Getinge plans spinout for Arjo extended care biz
Getinge (PINK:GETI B) is proposing to spin its Arjo extended care business into a separately traded public company, pending the approval of its shareholders next month. The Swedish medical device company said this week that it plans to ask stockowners Dec. 4 to approve the distribution of all Arjo shares in which each Series A and […]
7 medtech stories we missed this week: Sept. 22, 2017
From the FDA’s clearance of Covalon’s film-drape to Bioventus launching its study, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. FDA clears Covalon’s MediClear OTC surgical film-drape Covalon announced in a Sept. 21 press release that the FDA has cleared its MediClear PreOp to market in U.S. hospitals, […]
Getinge launches Biotronik’s Pulsar-18 SES in the US
Getinge (PINK:GETI B) said today it launched Biotronik‘s Pulsar-18 self-expanding stent in the US, operating as Biotronik’s distributor in the region for its portfolio of peripheral artery disease devices. Biotronik claims that the Pulsar-18, which won FDA clearance in March, is the only approved superficial femoral artery self-expanding stent with a 4-French delivery system, which it said […]
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 […]
Getinge’s Maquet, Datascope recall select IABPs over electrical issues
The FDA today released information on a select voluntary recall from Getinge‘s (PINK:GETI B) Datascope and Maquet of its System CS100, CS100i and CS300 intra-aortic balloon pumps over issues with potential electrical test failures. Datascope said they received a complaint in which the device failed to initiate therapy, resulting in a patient death. The complaint involved a […]
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, […]
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