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 […]
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Google taps ex-Geisinger CEO Feinberg to lead consolidated Google Health biz | Personnel Moves – November 14, 2018
Google (NSDQ:GOOG) has picked up former Geisinger Health CEO David Feinberg to lead its fragmented health divisions under the Google Health moniker, according to a recent CNBC report. The tech giant had been searching for a head for several months, with artificial intelligence head Jeff Dean heavily involved in the process, according to the report. Other […]
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 […]
Getinge’s Atrium Medical deals biosurg biz to SeCQure Surgical parent
Getinge (PINK:GETI B) subsidiary Atrium Medical said today that it agreed to deal its biosurgery business to the parent company of SeCQure Surgical for an undisclosed amount. Göteborg, Sweden-based Getinge acquired the biosurgery unit, which makes soft tissue reinforcement devices, in the $680 million deal for Atrium back in 2011. Today Getinge said it agreed to sell the business, which […]
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 […]
Getinge slips Abiomed counter-claim in patent spat with Maquet subsidiary
Getinge (PINK:GETI B) yesterday slipped out of a counter-suit filed by Abiomed (NSDQ:ABMD) against its Maquet subsidiary in an infringement spat over a blood pump patent. Danvers, Mass.-based Abiomed initially 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; counter-suits later brought […]
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 […]
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; […]
