Mar 12,2018

Medtronic Receives FDA Approval for Guardian Connect Continuous Glucose Monitoring (CGM) System for People Living with Diabetes

Medtronic plc, the global leader in medical technology, services and solutions, today announced it received U.S. Food and Drug Administration (FDA) approval for its Guardian Connect continuous glucose monitoring (CGM) system, for people with diabetes ages 14 to 75 years. The Guardian Connect system is the first smart standalone CGM system to help people with diabetes stay ahead of high and low glucose events. The Guardian Connect system empowers people using multiple daily injections (MDI) to more proactively manage their diabetes.

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Mar 27,2018

FDA Authorizes Marketing of the New Dexcom G6 CGM Eliminating the Need for Fingerstick Blood Testing for People with Diabetes

Dexcom is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted a De Novo request for the Dexcom G6® CGM System, the newest generation of CGM for people with diabetes ages 2 and up. The Dexcom G6 is indicated by the FDA for use as both a standalone CGM and for integration into automated insulin dosing (AID) systems. The powerful and revolutionary new Dexcom G6® is the first CGM to receive this classification by the FDA.

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Jun 04,2018

Insulet’s Omnipod® DASH™ Insulin Management System Receives FDA 510(k) Clearance

Insulet Corporation, the leader in tubeless insulin pump technology with its Omnipod® Insulin Management System (Omnipod System), today announced FDA 510(k) clearance of the Omnipod DASHTM Insulin Management System (Omnipod DASH). This clearance lays the foundation for a steady cadence of innovation that furthers Insulet’s mission to empower users to enjoy simplicity, freedom, and healthier lives with their differentiated technology.

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Jun 18,2018

FDA grants DreaMed's de novo request for device-friendly diabetes software

The FDA has granted Isreal-based DreaMed Diabetes a de novo request for its artificial intelligence-powered software for providers managing patients with Type 1 diabetes. Advisor Pro received a CE mark in February, and according to the company is being used by “leading clinical centers” in both the EU and the US.

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Jun 21,2018

Tandem Diabetes Care Announces FDA Approval of t:slim X2 Insulin Pump with Basal-IQ Technology

Tandem Diabetes Care®, Inc. (NASDAQ: TNDM), a medical device company and manufacturer of the only touchscreen insulin pumps available in the United States, today announced U.S. Food and Drug Administration (FDA) approval of the t:slim X2™ Insulin Pump with Basal-IQ™ technology, a predictive low glucose suspend (PLGS) feature designed to help reduce the frequency and duration of low glucose events (hypoglycemia).

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Jun 21,2018

Medtronic Receives FDA Approval of New Pediatric Indication for the MiniMed(TM) 670G Hybrid Closed Loop System in Children Ages 7-13

Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced that the U.S. Food and Drug Administration (FDA) has approved the use of the MiniMed 670G system in patients with type 1 diabetes seven years of age and older.

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Jul 30,2018

Abbott Receives FDA Approval of a 14-Day Version of Its Freestyle Libre CGM

Abbott has received FDA approval of a 14-day version of its Freestyle Libre continuous glucose monitoring system. The disposable, fingerstick-free system is comprised of a tiny insertable sensor and a patch roughly the size of a quarter that is worn on the arm. It was first approved by the agency in September 2017, for up to 10 days.

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Nov 01,2018

With new FDA clearance, Abbott Freestyle Libre users can ditch handheld readers for an app

Just a short while after securing a CE Mark for its second generation device, Abbott has been granted FDA clearance for FreeStyle LibreLink, a companion mobile app for its 10 to 14-day CGM. The launch adds a long-awaited feature for US users that’s been available for some time in Europe: users will be able to scan their sensors with an app on their smartphone — and see their latest reading — rather than requiring a separate, proprietary handheld reader (although the reader will still be an option for those that prefer it).

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Nov 06,2018

Senseonics Announces FDA Approval to Expand Eversense® CGM Certification to Nurse Practitioners and Physician Assistants

Senseonics Holdings, Inc. (NYSE American: SENS) a medical technology company focused on the development and commercialization of a long-term, implantable continuous glucose monitoring (CGM) system for people with diabetes, today has announced that the Eversense® Continuous Glucose Monitoring (CGM) System has received FDA approval for qualified health care providers to be trained and certified to provide patients with the highly accurate sensor that lasts up to three months.

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Dec 10,2018

POPS! Diabetes Care scores 510(k) for connected glucose monitoring system

Last week, the FDA granted a 510(k) clearance to POPS! Diabetes Care for its latest product, the POPS! one blood glucose monitoring system.

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