Jun 15,2020

ABBOTT'S FREESTYLE® LIBRE 2 ICGM CLEARED IN U.S. FOR ADULTS AND CHILDREN WITH DIABETES, ACHIEVING HIGHEST LEVEL OF ACCURACY AND PERFORMANCE STANDARDS

Abbott (NYSE: ABT), the worldwide leader in continuous glucose monitoring (CGM), announced today the U.S. Food and Drug Administration (FDA) cleared its next-generation FreeStyle® Libre 2 integrated continuous glucose monitoring (iCGM) system for adults and children ages 4 and older with diabetes. This is the only iCGM system with optional real-time alarms that measures glucose levels every minute, meeting the highest level of accuracy standards over 14 days, including superior day one accuracy compared to the other iCGM and excellent accuracy and alarm performance at low end glucose levels.

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Jun 17,2020

Tandem Diabetes Care Announces Expanded Pediatric Indication of the t:slim X2 Insulin Pump with Control-IQ Advanced Hybrid Closed-Loop Technology

Tandem Diabetes Care, Inc. (NASDAQ: TNDM), a leading insulin delivery and diabetes technology company, today announced U.S. Food and Drug Administration (FDA) clearance of an expanded pediatric indication for the t:slim X2™ insulin pump with Control-IQ™ technology to children age six and older.

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Sep 01,2020

Medtronic Announces FDA Approval for Minimed™ 770G Insulin Pump System with Smartphone Connectivity for People with Type 1 Diabetes

Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced it has received U.S. Food and Drug Administration (FDA) approval of its MiniMed™ 770G hybrid closed loop system. This newest insulin pump system offers the company’s most advanced SmartGuard™ technology, as featured in the MiniMed™ 670G system, with the added benefits of smartphone connectivity and an expanded age indication down to the age of 2 years old.

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Nov 11,2020

Brighter has now obtained all outstanding medical device regulatory approvals in the United Arab Emirates

On Monday November 9 Brighter announced that the Company's pioneering diabetes management solution, Actiste®, has received market approval in the UAE, but that some additional regulatory approvals for certain consumables included in the Actiste Service offering were still outstanding.

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Nov 23,2020

Tandem Diabetes Care Announces Health Canada Approval of the t:slim X2 Insulin Pump with Control-IQ Advanced Hybrid Closed-Loop Technology

Tandem Diabetes Care, Inc. (NASDAQ: TNDM), a leading insulin delivery and diabetes technology company, today announced Health Canada approval of the t:slim X2™ insulin pump with Control-IQ™ technology. Control-IQ technology is an advanced hybrid closed-loop feature designed to help increase time in range (3.9-10 mmol/L)1 and deliver automatic correction boluses in addition to adjusting insulin to help prevent high and low blood sugar.

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Dec 18,2020

Actiste® Mini receives market approval in the Kingdom of Saudi Arabia

Brighter AB (publ) is proud to announce that the diabetes management device Actiste® Mini has received market approval from the Saudi Food and Drug Authority (SFDA).

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