Device approvals

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DarioHealth Gets OK to Sell Smart Glucose Meters in Canada

DarioHealth Corp., a digital Therapeutics company, announced today the receipt of a license from Health Canada to sell its Dario™ Blood …

POPS! Diabetes Care Announces the Commercial Launch of Their New System

POPS! Diabetes Care announced the commercial launch of their POPS!® one diabetes management system following FDA clearance in November. …

Dexcom G6® CGM System Receives Health Canada Approval

Dexcom, Inc. announced last week that the company has received Health Canada approval for its next-generation Dexcom G6 CGM System for people with …

FDA OKs Tandem’s Insulin Pump Allowing Patients to Customize Treatment Using Their Own Devices

The U.S. Food and Drug Administration (FDA) today permitted marketing of the Tandem Diabetes Care t:Slim X2 insulin pump with interoperable …

Ascensia Diabetes Care Announces Partnership; New CGM Products

Ascensia Diabetes Care announced earlier this month that it has entered into a global alliance with Zhejiang POCTech, Co., Ltd, a Chinese company …

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 …