Device approvals

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Tandem Gets Approval of t:slim X2 Insulin Pump with Basal-IQ Tech. In Canada

Tandem Diabetes Care, Inc., announced the approval of the t:slim X2™ insulin pump with Basal-IQ™ technology in Canada. Basal-IQ …

Welldoc’s Digital Health Solution BlueStar Adds FDA-Clearance for Use in Type 1 Diabetes

Welldoc, a leading digital health company, announced today an additional FDA-clearance for its BlueStar® digital health product. The new …

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WaveForm Technologies Gets CE Mark Approval for CGM System

WaveForm Technologies Inc. announced it received CE Mark (Conformité Européenne) approval for its Cascade Continuous Glucose Monitoring (CGM) …

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Drawbridge’s Novel Blood Collection System Revolutionizes Traditional Blood Draw

Drawbridge Health recently received 510(k) clearance for a new blood collection system, the OneDraw™ A1C Test System from the U.S. Food and …

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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 …