Device approvals

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Drawbridge Health Gets FDA Clearance for its A1C Test System

Drawbridge Health today announced it received 510(k) clearance from the United States Food and Drug Administration (FDA) for the OneDraw™ A1C …

Senseonics Gets FDA Approval for New Dosing Indication for the Eversense® 90-day CGM

Senseonics Holdings, Inc., announced that they received FDA approval for the non-adjunctive indication (dosing claim) for the Eversense Continuous …

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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 …