Device approvals

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POPS! Diabetes Care Announces FDA Clearance of POPS!® one System

POPS! Diabetes Care received U.S. Food and Drug Administration (FDA) clearance of their POPS!® one Blood Glucose Monitoring System yesterday. …

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Diabeloop Gets Regulatory Approval for “Artificial Pancreas System” in Europe

Diabeloop announced this month it has received the CE marking for its “artificial pancreas system,” dubbed the DBLG1,™ for adults …

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Tandem Diabetes Care Receives Health Canada Approval to Market t:slim X2 Insulin Pump

Tandem Diabetes Care®, Inc., a medical device company and manufacturer of the only touchscreen insulin pumps with continuous glucose monitoring …

Xeris Pharmaceuticals Submits New Drug Application for Glucagon Rescue Pen

Xeris Pharmaceuticals Inc., submitted an NDA to the U.S. Food and Drug Administration yesterday for its Glucagon Rescue Pen, the company’s lead …

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Companion Medical Receives Two New Regulatory Clearances

Companion Medical has received FDA regulatory clearance for the Android version of its InPen(TM) app. The clearance paves the way for the release of …

FDA Approves “Artificial Pancreas” Device For Kids

Medtronic’s MiniMed™ 670G hybrid closed-loop system, also known as ‘the world’s first artificial pancreas,’ has won …

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