Apr 30,2018

Tandem Diabetes Care Receives CE Mark for t:slim X2 Insulin Pump

Tandem Diabetes Care®, Inc. (NASDAQ: TNDM) today announced receipt of CE mark approval for the t:slim X2™ Insulin Pump with Dexcom G5® Mobile continuous glucose monitoring (CGM) integration. The Company plans to begin commercial sales of the pump in select international markets beginning in the second half of 2018. The Company has been commercializing its touchscreen insulin pumps in the United States since 2012, and received U.S. Food and Drug Administration (FDA) approval of the t:slim X2™ Insulin Pump with Dexcom G5 Mobile CGM integration in August 2017.

REGULATORY CE MARK

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May 16,2018

A good report card: Glooko

Diabetes management company Glooko announced the results of how endocrinologists and diabetes educators viewed CGM data collected through the company’s platform. After assessing CGM data from 10 Type 1 diabetes patients, these participants most endorsed the platform’s hypoglycemia and variance features, and more than 70 percent of the participating clinicians endorsed use of three or more of the platform’s CGM data features for patients.

CLINICAL STUDY

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May 17,2018

Startup LifePlus announces noninvasive CGM wearable currently in testing

Yesterday, startup LifePlus exited stealth mode to reveal what it claims to be the first noninvasive continuous blood glucose monitoring multi-sensor wearable, called LifeLeaf. Although details are scarce on exactly how the technology works, the company said the product is being tested in five clinical trials around the world.

PRODUCT

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May 30,2018

Nemaura Medical Signs Joint Collaboration Agreement for European Commercialization

Nemaura Medical Inc. (NASDAQ: NMRD), a medical technology company developing the wireless sugarBEAT® non-invasive glucose monitoring system for adjunctive use by persons with diabetes, today announced that it has entered in to a definitive joint Collaboration Agreement with Dallas Burston Ethitronix (DBE) to commercialize sugarBEAT® in the European Economic Area (EEA).

COLLABORATION PARTNERSHIP

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Jun 13,2018

CMS relents, opens up smartphone-connected CGMs for reimbursement

The Centers for Medicare and Medicaid Services will reverse a longstanding unpopular position on reimbursement for smartphone-connected continuous glucose monitors, CMS announced yesterday.

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Jun 19,2018

Medtronic, Nutrino partner to bring nutrition info to glucose monitoring app

Medtronic is teaming up with Nutrino, an AI powered personalized nutrition platform. Nutrino’s FoodPrint Report technology will now be integrated into Medtronic’s iPro2 myLog app, a platform that connects with a continuous glucose monitor to help give users insights about their glucose levels. The new technology will enable doctors and clinicians to see the food that a person has logged during their iPro2 cgm evaluation, and will let users see how their bodies react to different foods and will show them the connection between a meal and glucose variability. 

COLLABORATION PARTNERSHIP

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Jun 12,2018

Dexcom G5 Continuous Glucose Monitoring System Now Available on Mobile, Smart Devices for Medicare Patients with Diabetes

Dexcom announced today the U.S. Centers for Medicare & Medicaid Services (CMS) is updating its policy on mobile device compatibility for the Dexcom G5® CGM System. Available on iOS and Android, the Dexcom G5 is the first and only mobile-enabled CGM system for Medicare patients with diabetes that works to display and share real-time glucose activity.

PRODUCT

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Jun 18,2018

FDA grants DreaMed's de novo request for device-friendly diabetes software

The FDA has granted Isreal-based DreaMed Diabetes a de novo request for its artificial intelligence-powered software for providers managing patients with Type 1 diabetes. Advisor Pro received a CE mark in February, and according to the company is being used by “leading clinical centers” in both the EU and the US.

REGULATORY FDA

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Jun 19,2018

Medtronic Introduces Updated iPro(TM)2 myLog App with FoodPrint(TM) Report Enhancing Diagnostic CGM for People with Diabetes

Medtronic (NYSE:MDT), the global leader in medical technology, today announced the availability of the updated iPro(TM)2 myLog app with FoodPrint(TM) Report. The iPro2 myLog app offers a simple way for clinics to import patients' logged data during their professional iPro2 continuous glucose monitoring (CGM) evaluation.

PRODUCT

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Jul 30,2018

Abbott Receives FDA Approval of a 14-Day Version of Its Freestyle Libre CGM

Abbott has received FDA approval of a 14-day version of its Freestyle Libre continuous glucose monitoring system. The disposable, fingerstick-free system is comprised of a tiny insertable sensor and a patch roughly the size of a quarter that is worn on the arm. It was first approved by the agency in September 2017, for up to 10 days.

REGULATORY FDA

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