Tag: Medtronic

FDA Warns of Cybersecurity Risk With Certain Medtronic Insulin Pumps

September 22, 2022
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The U.S. Food and Drug Administration on Tuesday warned that certain types of insulin pump systems manufactured by Medtronic were vulnerable to cyberattacks and that hackers could potentially hamper insulin delivery by accessing the device. The agency issued a cybersecurity risk alert for the Medtronic MiniMed 600 Series insulin pump system, which has several components…

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US Health Regulator Flags Concerns at Medtronic’s Diabetes Business

December 17, 2021
Business & EconomyCompaniesFDAMedtronicUSUS News
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The U.S. health regulator has issued a warning letter to Medtronic Plc, highlighting certain concerns related to medical device quality management at its diabetes business, the company said on Wednesday. Medtronic’s shares were down 6 percent at $104.95 in early trading, hitting their lowest in over a year. The Food and Drug Administration’s (FDA) letter…

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FDA Warns Doctors to Stop Using Heart Pump Tied to Deaths

June 3, 2021
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WASHINGTON—U.S. health regulators warned surgeons Thursday to stop implanting a heart pump made by Medtronic due to power failures recently tied to cases of stroke and more than a dozen deaths. Medtronic said earlier in the day it would stop selling its Heartware assist device, which is intended to boost blood circulation in patients with…

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