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Getinge

Getinge to expand ventilator production

April 6, 2020 By Sean Whooley

Getinge (STO:GETI-B) Getinge announced today that it is more than doubling its production capacity for intensive care unit ventilator machines amid the COVID-19 pandemic. The Gothenburg, Sweden-based company said in a news release that it produced 10,000 ventilators in 2019 and is set to increase that number to 26,000 (160% increase) in 2020. Getinge had already […]

Filed Under: Business/Financial News, Featured, Respiratory Tagged With: coronavirus, COVID-19, Getinge

Getinge issues urgent field safety notice for 88-series

January 21, 2020 By Sean Whooley

Getinge (STO:GETI-B) issued an urgent field safety notice in Europe to warn customers of a potential leakage issue with its 88-5 washer disinfector. According to the safety notice out of Germany, the leakage may occur from the device in ruptured spot welds in the chamber, in some instances due to a worn door seal. The […]

Filed Under: Lab Instruments & Supplies, Recalls, Regulatory/Compliance Tagged With: Getinge

Getinge shares drop on news of more deaths, injuries linked to faulty IABPs

November 19, 2019 By Nancy Crotti

Shares of Getinge (STO:GETI-B) dropped 5% today on news that the FDA had received 60 more reports of adverse events — including two deaths and one serious injury — related to the company’s Maquet/Datascope intraortic balloon pumps (IABP). The FDA said the new reports have come in since it issued a letter in November 2018 […]

Filed Under: Business/Financial News, Cardiovascular, Catheters, Featured, Recalls, Regulatory/Compliance, Wall Street Beat Tagged With: FDA, Getinge

Maquet recalls arterial filters

October 2, 2019 By Nancy Crotti

Getinge subsidiary Maquet Cardiovascular is recalling its Quart arterial filter, used during coronary bypass surgery, because transportation may compromise its sterile packaging. A transportation simulation test revealed the problem, according to an August 27, 2019, letter to customers. Patients who are exposed to non-sterile medical devices while undergoing extracorporeal circulation may develop an infection and […]

Filed Under: Blood Management, Cardiovascular, Featured, News Well, Recalls, Sterilization / Calibration Tagged With: Getinge, Maquet Cardiovascular LLC

Getinge recalls cardiac pumps following reports of 5 deaths

July 24, 2019 By Nancy Crotti

Getinge (STO:GETI-B) is recalling four models of Maquet/Datascope intra-aortic balloon pumps (IABP) due to reports of faulty batteries. Five deaths have been reported since March 2016. The IABP batteries failed to hold a charge, stopped unexpectedly, or had a shortened run-time, which may have caused the device to stop working when being operated by battery […]

Filed Under: Food & Drug Administration (FDA), Recalls, Structural Heart Tagged With: Datascope, FDA, Getinge, Maquet

Getinge launches new surgical table in U.S.

May 2, 2019 By Chris Newmarker

Getinge (STO:GETI-B) today announced the U.S. launch of its Maquet Yuno II surgical table, which the company touts as a versatile option to support advanced orthopedic techniques. Officials at the Swedish medical device company the table — with its multiple configurations supporting a variety of procedures — could also reduce the complexity of setup for […]

Filed Under: Business/Financial News, News Well Tagged With: Getinge

FDA warn’s Getinge’s Datascope about ongoing IABP issues

February 25, 2019 By Fink Densford

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 […]

Filed Under: Featured, Food & Drug Administration (FDA), Regulatory/Compliance Tagged With: Datascope Corp., Getinge

Google taps ex-Geisinger CEO Feinberg to lead consolidated Google Health biz | Personnel Moves – November 14, 2018

November 14, 2018 By Fink Densford

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 […]

Filed Under: Business/Financial News, Featured Tagged With: Accuray Inc., Alphabet (Google), BioCardia, Bovie Medical Corp., Clearside Biomedical, Eos Imaging, Geisinger Health System, Getinge, hancockjaffelabs, Intact Vascular, Integra LifeSciences, Intuitive Surgical, mperiatherapeutics, Owens and Minor, Procept BioRobotics, Profound Medical Inc., Verily

FDA warns of battery shutdown issues with Getinge’s Maquet/Datascope IABPs

November 2, 2018 By Fink Densford

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 […]

Filed Under: Cardiovascular, Featured, Food & Drug Administration (FDA), Structural Heart Tagged With: Datascope Corp., Getinge, Maquet Cardiovascular LLC

Getinge’s Atrium Medical deals biosurg biz to SeCQure Surgical parent

October 18, 2018 By Brad Perriello

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 […]

Filed Under: Featured, Mergers & Acquisitions, Surgical, Wall Street Beat Tagged With: Atrium Medical Corp., Getinge, SeCQure Surgical

FDA warns Getinge’s Datascope over IABP production facility issues

October 3, 2018 By Fink Densford

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 […]

Filed Under: Food & Drug Administration (FDA), Regulatory/Compliance Tagged With: Datascope Corp., Getinge

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