Feb 14,2022

ASCENSIA DIABETES CARE ANNOUNCES FDA APPROVAL OF THE EVERSENSE E3 CONTINUOUS GLUCOSE MONITORING SYSTEM FOR USE FOR UP TO 6 MONTHS

Ascensia Diabetes Care, a global diabetes care company, announces that its partner Senseonics Holdings, Inc. (NYSE American: SENS) has received approval from the U.S. Food and Drug Administration (FDA) for the next-generation Eversense ® E3 Continuous Glucose Monitoring (CGM) System. Ascensia plans to make the Eversense E3 sensor, which can be used for up to 6 months, available to patients in the U.S. during the second quarter of 2022.

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Feb 16,2022

Tandem Diabetes Care Announces FDA Clearance for the t:slim X2 Insulin Pump to Bolus Using the t:connect Mobile App

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 bolus insulin dosing on the t:slim X2 insulin pump using the t:connect mobile app.

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Mar 02,2022

Dexcom wins FDA breakthrough nod for use of its CGM in hospitals

Dexcom (NSDQ:DXCM) announced that it received FDA breakthrough device designation for the use of its CGM in a hospital setting. The FDA early in the COVID-19 pandemic issued temporary guidance allowing increased remote monitoring of hospital patients in order to limit contact with hospital staff.

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Jul 28,2022

Dexcom to update next-gen G7 software, delaying FDA clearance, launch timelines

The CEO of Dexcom (Nasdaq:DXCM) said today that the company’s regulatory path for the next-generation G7 has been slightly delayed.

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Aug 22,2022

Insulet Announces FDA Clearance of Omnipod® 5 for Children Aged Two Years and Older with Type 1 Diabetes

Insulet Corporation, the global leader in tubeless insulin pump technology with its Omnipod® brand of products, today announced it has received clearance from the U.S. Food and Drug Administration (FDA) for its Omnipod® 5 Automated Insulin Delivery System (Omnipod 5) for individuals aged two years and older with type 1 diabetes (T1D). Omnipod 5, the first tubeless automated insulin delivery (AID) system in the U.S., was originally cleared for use in individuals aged six and older in January 2022.

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Jan 07,2021

Brighter's diabetes solutions Actiste® and Actiste® Mini have received market approval in Thailand

Brighter AB (publ) is proud to announce that the Actiste® unit and the newly developed Actiste® Mini unit have received market approval from the Thai FDA, which is a requirement to be able to start importing and marketing the products.

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Jan 25,2021

Brighter has received pending approval for consumables linked to Actiste in Saudi Arabia

Brighter has now received the outstanding approval of consumables connected to the Actiste service from the SFDA (Saudi Food and Drug Authority) in Saudi Arabia. The approval process with the country's telecommunications authority (CITC) regarding cellular connectivity is still ongoing.

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Apr 26,2021

BD Announces FDA 510(k) Submission for BD Alaris™ System

The 510(k) submission is intended to bring the regulatory clearance for the BD Alaris™ System up to date, implement updated features and address open recall issues, including through a new version of BD Alaris™ System software that will provide clinical, operational and cybersecurity updates.

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May 14,2021

One Drop Receives CE Mark for AI-Powered Blood Glucose Forecasts

Powered by nearly 25 billion health data points, One Drop’s CE-marked glucose predictions enable people living with chronic conditions to be proactive about their health

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May 26,2021

Medtronic Secures Two CE Mark Approvals for Guardian 4 Sensor & for InPen MDI Smart Insulin Pen

The company also announced CE Mark for its Guardian™ 4 sensor3, which requires no fingersticks1 for calibration or diabetes treatment decisions. The CE Mark allows this next-generation sensor to be integrated with either the MiniMed™ 780G insulin pump system or InPen, or for stand-alone continuous glucose monitoring (CGM) use.

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