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Technology FDA clears an interoperable, automated insulin pump

15:15  15 december  2019
15:15  15 december  2019 Source:   engadget.com

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It might soon be decidedly easier for Americans to manage diabetes -- the FDA has approved the sale of an interoperable , automated insulin pump Tandem Diabetes Care's updated t:slim X2 can pair with a Dexcom G6 glucose monitor to dynamically adjust your insulin levels and keep you in a safe

The U.S. Food and Drug Administration today permitted marketing of the Tandem Diabetes Care t:Slim X2 insulin pump with interoperable technology ( interoperable t Insulin pumps to date have either been cleared by the FDA as stand-alone devices (class II, moderate risk devices) or approved

It might soon be decidedly easier for Americans to manage diabetes -- the FDA has approved the sale of an interoperable, automated insulin pump for the first time. Tandem Diabetes Care's updated t:slim X2 can pair with a Dexcom G6 glucose monitor to dynamically adjust your insulin levels and keep you in a safe glucose range for longer. It can accommodate exercise and sleep, and the Dexcom tie-in spares you from having to stick your finger when you're either dosing yourself at meal time or calibrating.

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The software needed to make this work will be ready in January 2020, although you can't expect to walk into a store and buy this. US law will still require that you buy the pump from (or on the order of) a physician.

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The US Food and Drug Administration has approved Medtronic’s MiniMed 670G, a medical device that monitors a diabetic’s sugar levels, and then automatically injects the So they must replenish their insulin stock either with multiple daily injections, or by pumping insulin through a tiny catheter.

Insulin pumps to date have either been cleared by the FDA as standalone devices (class II, moderate risk devices) or approved by the FDA as part of a single, predefined diabetes management system (class III, highest-risk devices). Because the interoperable t:Slim X2 insulin pump is interoperable

This isn't the first time the FDA has cleared multiple devices to work together for automated insulin dosing. However, this new category could theoretically improve the quality of life for diabetics. You could keep your glucose levels balanced in a more seamless, pain-free way with equipment that should be easy to use. It won't be surprising if there's a surge of interconnected devices like this in the relatively near future.

Business Wire, FDA

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