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Medtronic's (MDT) strategic acquisition of Companion Medical strengthens the company's data science and AI capabilities.
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In September 2016, the FDA approved the Medtronic MiniMed 670G, which was the first approved hybrid closed loop system. The device automatically adjusts a patient's basal insulin delivery. [7] It is made up of a continuous glucose monitor, an insulin pump, and a glucose meter for calibration.
Featuring the company's advanced algorithm - SmartGuard technology and glucose sensor - Guardian™ Sensor 3, it was the first insulin pump approved by the Food and Drug Administration (FDA) that enabled personalized and automated* delivery of basal insulin, the background insulin needed to maintain stable blood sugar levels throughout the day ...
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Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), is a United States Supreme Court case in which the Court held that the pre-emption clause of the Medical Device Amendment bars state common-law claims that challenge the effectiveness or safety of a medical device marketed in a form that received premarket approval from the Food and Drug Administration.
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