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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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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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 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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Feb 26,2018

FDA expands indication for MiniMed 670G's CGM to include upper arm

The FDA has expanded its indication for Medtronic’s Guardian Sensor 3, allowing patients to wear the sensor on their upper arm. The sensor is part of Medtronic’s MiniMed 670G system, and is currently the only continuous glucose monitor approved by the FDA to control automated insulin delivery via a hybrid closed loop system.

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Feb 26,2018

Medtronic Receives FDA Approval for New Arm Indication for Guardian(TM) Sensor 3 - Further Enhancing the MiniMed(TM) 670G Hybrid Closed Loop Experience

Medtronic plc, the global leader in medical technology, today announced that the U.S. Food and Drug Administration (FDA) has approved a new arm indication for the Guardian Sensor 3. This expanded indication will enable patients to wear the sensor on the upper arm - delivering more flexibility and enhanced performance for users, as well as improved accuracy, with a MARD of 8.7 percent following typical calibration methods used with the MiniMed 670G system.

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Mar 27,2018

DarioHealth granted 510(k) clearance for Apple Lightning-compatible glucose monitor

Israel-based DarioHealth has been granted 510(k) clearance for a version of its Blood Glucose Monitoring System that, alongside the Dario app, is compatible with iPhone 7, 8, and X, according to a statement from the company.

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