May 26,2021

One Drop Receives CE Mark, Launches Data-Driven Insights for People Managing High Blood Pressure

The CE-marked feature offers real-time insights on how a member’s blood pressure is trending, providing them the opportunity to mitigate risks associated with high blood pressure proactively.

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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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#insulin pen

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Jun 07,2021

Voluntis receives FDA 510(k) clearance for a new version of Insulia supporting an expanded range of basal insulins

Voluntis a leader in digital therapeutics, today announced that it has received the FDA 510(k) clearance for a new version of Insulia supporting an additional basal insulin product, expanding the scope of insulins covered by the solution. Voluntis’ flagship diabetes digital therapeutic, Insulia, helps people with type 2 diabetes with dose titration. It is indicated for patients with type 2 diabetes initiating or uncontrolled on basal insulin, treated with a wide range of basal insulin analogues, including all approved insulin glargines.

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#mobile app

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Aug 02,2021

ABBOTT'S FREESTYLE® LIBRE 2 IOS APP CLEARED IN U.S., PROVIDING A SEAMLESS DIGITAL EXPERIENCE TO SIMPLIFY DIABETES MANAGEMENT

Abbott announced today that the U.S. Food and Drug Administration (FDA) has cleared the FreeStyle® Libre 2 iOS application for use with compatible iPhones1, providing a comprehensive digital offering for its FreeStyle Libre 2 integrated continuous glucose monitoring (iCGM) system. Providing breakthrough technology that is accessible and affordable4, the FreeStyle Libre portfolio is the number one continuous glucose monitoring (CGM) system worldwide5 and most prescribed in the U.S.6, changing the lives of nearly 3.5 million people across more than 50 countries including 1 million users in the U.S.

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#mobile app

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Sep 22,2021

Welldoc Receives Ninth 510(k) for Award-Winning Diabetes Platform, BlueStar®

Welldoc, a digital health leader revolutionizing chronic care, today announced the receipt of its ninth 510(k) clearance from the Food and Drug Administration (FDA) for its award-winning diabetes platform, BlueStar®. The new clearance expands insulin dosing support to most types of insulin, including Bolus and Premixed Insulin titration for type 2 diabetes.

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#dtx

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Jun 28,2022

FDA Approved Device in 2022 | TaiDoc

Based on the customer’s demands, and market trend that Taidoc have submitted cholesterol parameter to FDA and now gratefully to announce that it has passed FDA Class II with 510(k) in June 2022.

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#cgm

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Nov 03,2021

POGO Automatic One-Step™ Blood Glucose Monitor Now Available for People with Diabetes in the United States

Intuity Medical, Inc., a commercial-stage medical technology and digital health company focused on making life with diabetes easier, announced today the availability of the POGO Automatic® Blood Glucose Monitoring System in the U.S. The product is the first and only FDA-cleared blood glucose monitor whose 10-test cartridge technology makes a glucose test possible with only the press of a button and without needing to carry separate test strips and lancets.

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#bgm

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Dec 21,2021

Eversense NOW Remote Monitoring App for Android Users Receives CE Mark in Europe

Senseonics Holdings, Inc. (NYSE American: SENS) a medical technology company focused on the development and manufacturing of long-term, implantable continuous glucose monitoring (CGM) systems for people with diabetes, today announced it received CE mark of the Eversense® NOW Remote Monitoring App for the Android Operating System. The Eversense NOW iOS platform has previously been approved and is currently available in Europe.

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#cgm

#rpm

#mobile app

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Mar 02,2020

Tandem Diabetes Care Announces FDA Designation of Basal-IQ Technology as an Interoperable Automated Glycemic Controller

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 its Basal-IQ™ technology as an interoperable automated glycemic controller (iAGC). This is the second system to receive iAGC designation by the FDA, following the Company’s clearance of the t:slim X2™ insulin pump with Control-IQ™ technology in December 2019.

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Mar 30,2020

Jana Care receives US FDA clearance for Aina HbA1c Monitoring System 2

Jana Care today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of the Aina HbA1c Monitoring System 2, an automated glycated hemoglobin (HbA1c) test system. Glycated hemoglobin is primarily used to determine the three-month average blood sugar level and can be used to monitor long term glycemic control of persons previously diagnosed with diabetes. The system is among the first smartphone-based blood testing devices approved by the US FDA.

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