After back-to-back all-time best performances, the medtech industry had a slight regression over the course of the last week. MassDevice‘s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — had been continuously ticking up since the beginning of April, with its mark of 112.25 on April 16 representing an all-time […]
Getinge
DTW Podcast: Can Proximie bring safer surgery to the wider world?
In this week’s podcast, senior executives from Getinge and Proximie – two very different sized companies – explain how the COVID-19 pandemic accelerated their business. In the opening keynote conversation, Eric Honroth, president, Getinge North America, explained how the company more than doubled its production of ventilators in 2020. He also discusses recent FDA clearances […]
Getinge wins 3 FDA clearances for ventilators
Getinge announced today that it received FDA 510(k) clearance for three products to expand its Servo platform of ventilators. Gothenburg, Sweden-based Getinge’s latest clearances are for new software options for the Servo-u and Servo-n ventilators, as well as clearance for use of the new Servo-u MR ventilator in the MRI room, according to a news release. […]
Getinge to expand ventilator production
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 […]
Getinge issues urgent field safety notice for 88-series
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 […]
Getinge shares drop on news of more deaths, injuries linked to faulty IABPs
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 […]
Maquet recalls arterial filters
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 […]
Getinge recalls cardiac pumps following reports of 5 deaths
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 […]
Getinge launches new surgical table in U.S.
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 […]
FDA warn’s Getinge’s Datascope about ongoing IABP issues
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 […]
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 […]
