Jun 07,2019

Senseonics scores coveted non-adjunctive labeling claim for Eversense CGM

Implantable CGM company Senseonics has received approval from the FDA for the non-adjunctive indication for its Eversense device.

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Jul 25,2019

DarioHealth USB Type C Connector for the European Android Market Is CE Marked

Global digital therapeutics innovator DarioHealth Corp. (Nasdaq: DRIO), today announced that its CE certificate covers a USB-C connector enabled version of the acclaimed Dario™ Blood Glucose Monitoring System. The USB-C connector is used to transfer power and communication signals between Android smart mobile devices and the Dario meter, and ensures that consumers, beginning with the Europe market region, will receive the same quality user experience with DarioHealth on the latest Android smart phone devices.

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Aug 22,2019

DIAMONTECH'S FIRST PRODUCT 'DMT BASE' RECEIVES CE CERTIFICATION FOR NON-INVASIVE BLOOD GLUCOSE MEASUREMENT USING LASER-BASED TECHNOLOGY

DiaMonTech GmbH, a young medical technology company, has received CE certification for its first medical product "DMT Base". The device enables non-invasive blood glucose measurement using laser-based technology. The certification confirms that the patented technology meets the high safety and performance standards for medical devices required for market approval. The marking applies to all countries of the European Union.

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Sep 03,2019

Actiste – world’s first unified IoT diabetes care device – has received market approval (CE mark).

Actiste®, the world’s first unified diabetes care device with eSIM technology for monitoring and treating insulin-dependent diabetes, has received not only one, but two, EC certificates (CE marks) from TÜV Rheinland (Notified Body).

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Oct 08,2019

Dexcom Announces FDA Clearance of New Dexcom G6 Pro CGM

Dexcom, Inc. announced today the U.S. Food and Drug Administration (FDA) has cleared the Dexcom G6 Pro Continuous Glucose Monitoring (CGM) System for healthcare professionals to use with their patients, ages two years and up.

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Oct 25,2019

Fiasp® Rapid Acting Insulin for Adults Now Approved for Use With the Omnipod Insulin Management System Platform in the United States

Insulet Corporation (NASDAQ: PODD) (Insulet or the Company), the leader in tubeless insulin pump technology with its Omnipod® Insulin Management System (Omnipod System), today announced FDA clearance for use of Fiasp® (fast-acting insulin aspart) with the Omnipod® Insulin Management System and the Omnipod DASH™ Insulin Management System for adults.

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Nov 05,2019

WellDoc's BlueStar cleared for Type 1 diabetes management, CGM integrations

This is the seventh FDA clearance for the longstanding mobile diabetes management platform.

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Dec 10,2019

Roche receives CE Mark for its Accu-Chek SugarView app

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that it has obtained the CE Mark for its Accu-Chek SugarView app. This paves the way for the launch of the innovative diabetes management solution in Europe and further countries around the world requiring the CE Mark. Now officially classified as in-vitro diagnostics (IVD) software, the app will be made widely accessible by Roche first for certain smartphone models via the Google Play Store, thus enabling broader access to therapy relevant information for non-insulin dependent people with type 2 diabetes or pre-diabetes.

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Dec 13,2019

Tandem Diabetes Care Announces FDA Clearance of the t:slim X2 Insulin Pump with Control-IQ Advanced Hybrid Closed-Loop Technology

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 the t:slim X2™ insulin pump with Control-IQ™ technology, an advanced hybrid-closed loop feature designed to help increase time in range (70-180 mg/dL), and the first system cleared to deliver automatic correction boluses in addition to adjusting insulin to help prevent high and low blood sugar.

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Feb 14,2018

Glooko receives FDA clearance for mobile insulin titration tool

Digital diabetes care company Glooko announced today that its Mobile Insulin Dosing System (MIDS) — an app-driven tool that recommends insulin dose adjustments using data collected directly from a patient’s blood glucose meter — has been cleared by the FDA.

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