Jan 08,2018

Tandem Diabetes Care Reports Successful Completion of First Pilot Study Using t:slim X2 Insulin Pump with TypeZero Hybrid Closed Loop Technology and Dexcom G6 Integration; Confirms IDCL Multi-site Study Timeline

Tandem Diabetes Care®, Inc. (NASDAQ: TNDM), a medical device company and manufacturer of the only touchscreen insulin pumps available in the United States, today reported the successful completion of the first pilot study using a hybrid closed loop system featuring its t:slim X2™ Insulin Pump with embedded algorithms from TypeZero Technologies and integration with Dexcom® G6 Continuous Glucose Monitoring (CGM). This pilot study was the first of three in the National Institute of Health (NIH)-funded International Diabetes Closed Loop (IDCL) Trial using the t:slim X2 Pump running the algorithm directly on the pump. The second study is now moving forward with enrollment at seven clinical sites and is anticipated to begin in the first quarter of 2018. The IDCL Trial is expected to conclude with a pivotal study in 2018, and Tandem plans to use this data in a PMA submission to the U.S. Food and Drug Administration.

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Jan 31,2018

Nemaura Announces Positive Results for its SugarBEAT® European Clinical Program

Nemaura Medical Inc., a medical technology company developing the wireless sugarBEAT® non-invasive glucose monitoring system for adjunctive use by persons with diabetes today announced positive summary data for its sugarBEAT® European clinical trial program.

CLINICAL STUDY

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Feb 21,2018

Senseonics adds friends-and-family data sharing to CGM app in EMEA market

Implantable glucose sensor company Senseonics has launched a remote monitoring app for its users in Europe, the Middle East, and Africa, where its CGM system is distributed by Roche.

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Feb 26,2018

FDA expands indication for MiniMed 670G's CGM to include upper arm

The FDA has expanded its indication for Medtronic’s Guardian Sensor 3, allowing patients to wear the sensor on their upper arm. The sensor is part of Medtronic’s MiniMed 670G system, and is currently the only continuous glucose monitor approved by the FDA to control automated insulin delivery via a hybrid closed loop system.

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Feb 20,2018

Tandem Diabetes Care Applies for Health Canada Medical Device License

Tandem Diabetes Care®, Inc., a medical device company and manufacturer of the only touchscreen insulin pumps, today announced its submission of a medical device license application to Health Canada to market its t:slim X2™ Insulin Pump with Dexcom G5® Mobile continuous glucose monitoring (CGM) integration. The Company plans to launch the pump in Canada in the second half of 2018, subject to regulatory approvals.

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Feb 26,2018

Medtronic Receives FDA Approval for New Arm Indication for Guardian(TM) Sensor 3 - Further Enhancing the MiniMed(TM) 670G Hybrid Closed Loop Experience

Medtronic plc, the global leader in medical technology, today announced that the U.S. Food and Drug Administration (FDA) has approved a new arm indication for the Guardian Sensor 3. This expanded indication will enable patients to wear the sensor on the upper arm - delivering more flexibility and enhanced performance for users, as well as improved accuracy, with a MARD of 8.7 percent following typical calibration methods used with the MiniMed 670G system.

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Mar 20,2018

Study finds wearable heart rate monitors feasible for early detection of hypoglycemia

Data from a team of Dutch researchers presented this weekend at the Endocrinology Society’s annual meeting in Chicago demonstrated how vital monitoring wearables could identify Type 1 diabetes patients’ hypoglycemic events by measuring heart rate.

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Mar 12,2018

Medtronic Receives FDA Approval for Guardian Connect Continuous Glucose Monitoring (CGM) System for People Living with Diabetes

Medtronic plc, the global leader in medical technology, services and solutions, today announced it received U.S. Food and Drug Administration (FDA) approval for its Guardian Connect continuous glucose monitoring (CGM) system, for people with diabetes ages 14 to 75 years. The Guardian Connect system is the first smart standalone CGM system to help people with diabetes stay ahead of high and low glucose events. The Guardian Connect system empowers people using multiple daily injections (MDI) to more proactively manage their diabetes.

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Mar 14,2018

Introducing the new CGM by Metronom

Metronom Health, founded in 2010, recently announced that they are poised to bring a new CGM to the market. They are promising a product that is an improvement on existing technology, offering better accuracy and reliability, a longer and more convenient wear period, affordability, and a more comprehensive user interface.

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Mar 27,2018

FDA Authorizes Marketing of the New Dexcom G6 CGM Eliminating the Need for Fingerstick Blood Testing for People with Diabetes

Dexcom is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted a De Novo request for the Dexcom G6® CGM System, the newest generation of CGM for people with diabetes ages 2 and up. The Dexcom G6 is indicated by the FDA for use as both a standalone CGM and for integration into automated insulin dosing (AID) systems. The powerful and revolutionary new Dexcom G6® is the first CGM to receive this classification by the FDA.

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