Sep 28,2016

Abbott gets FDA clearance to bring FreeStyle Libre Pro CGM to US

Abbott has received FDA Clearance for its FreeStyle Libre Pro system, a key milestone in bringing the company's unique take on the continuous glucose monitor to the United States. In Europe, where the system has had CE Mark clearance since September 2014, there is both a prescription and over-the-counter version available and the latter is smartphone compatible.

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Sep 29,2016

Medtronic gets FDA nod for artificial pancreas system, preps to launch Watson-powered Sugar.IQ app

Medtronic came out with two pieces of news yesterday around its connected diabetes efforts: an FDA clearance for a hybrid closed loop insulin delivery system and the first test cohort of its Sugar.IQ app, created in collaboration with IBM Watson.

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Nov 21,2016

ASCENSIA DIABETES CARE RECEIVES FDA CLEARANCE FOR THE APP-ENABLED CONTOUR®NEXT ONE BLOOD GLUCOSE MONITORING SYSTEM

Ascensia Diabetes Care announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the CONTOUR®NEXT ONE Blood Glucose Monitoring System (BGMS), marking a key step in making the next-generation system available to people living with diabetes in the U.S.

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Dec 06,2016

Voluntis gets both FDA and CE Mark for diabetes management app, Insulia

Voluntis, which makes companion software for medical devices or medications, has received both FDA clearance and the CE Mark for a type 2 diabetes management app called Insulia. The app, which is designed for people treated with basal insulin, is classified as a prescription-only medical device and will be available to patients and healthcare providers in the first half of 2017.

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Dec 20,2016

FDA approves Dexcom G5 for use without a fingerstick glucometer

The FDA has officially cleared the Dexcom G5 continuous glucose monitor to inform treatment decisions -- without the use of a fingerstick glucometer, other than for calibration. The G5 has been cleared for a while to complement a traditional glucometer, but this non-adjunctive clearance is the first of its kind according to Dexcom and the FDA, which both released statements.

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Dec 06,2016

One Drop Announces FDA Clearance and One Drop | Premium Launch in US, UK, and EU

One Drop today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance and Conformité Européene (CE) mark approval for One Drop | Chrome, a beautiful blood glucose monitoring system that marries modern design with advanced medical and mobile technology.

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Dec 19,2016

POCTech achieved the first CE certificate of CGMS

Continuous Glucose Monitoring system of POCTech Corporation received first CE certificate, it is a key point for this product to get into European medical market.

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Jan 12,2015

Tandem Diabetes Care Announces FDA Clearance of the t:flex™ Insulin Pump

Tandem Diabetes Care®, Inc. (NASDAQ: TNDM), a medical device company and manufacturer of the t:slim® Insulin Pump, today announced that the U.S. Food and Drug Administration (FDA) has granted the Company clearance to market the t:flex™ Insulin Pump. At 480 units, the insulin reservoir of the t:flex Pump has the largest capacity currently available in the United States.

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Jan 26,2015

FDA Approves Dexcom G4 Platinum Continuous Glucose Monitoring System with Share

Dexcom announced today that it has received U.S. Food and Drug Administration (FDA) approval for its Dexcom G4® PLATINUM Continuous Glucose Monitoring System with Share. The Dexcom Share receiver uses a secure wireless connection via Bluetooth Low Energy (BLE) between a patient's receiver and an app on the patient's smartphone to transmit glucose information to apps on the mobile devices of up to five designated recipients, or "followers," without the need for a dedicated docking cradle. These followers can remotely monitor a patient's glucose information and receive alert notifications from almost anywhere, initially via their Apple® iPhone® or iPod® touch and in the future on Android devices, giving them peace of mind and reassurance when they are apart. The "Share" and "Follower" apps will be available on the Apple App Store at no charge.

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Apr 03,2015

Artificial pancreas software algorithm receives approval in europe

The Glucositter software algorithm has received a CE Mark in Europe, but the big question is when and how this software will reach patients. Currently, the system runs on a laptop, but a handheld device for patients is an ideal choice. DreaMed Diabetes is the company in charge of commercializing the closed-loop system consisting of software algorithm, pump, and continuous glucose monitoring (CGM).

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