Feb 15,2018

DreaMed Diabetes has received a CE Mark for its Type 1-focused clinical decision support (CDS) platform

DreaMed Diabetes has received a CE Mark for its Type 1-focused clinical decision support (CDS) platform, Advisor Pro. The tool’s algorithms process data from a number of connected diabetes management devices to provide a personalized insulin dosing treatment plan. The software achieved similar glycemic control when compared to medical experts during pilot studies, according to DreaMed, and a multi-center trial run with Glooko (which announced a similar approval yesterday) is currently underway.

REGULATORY CE MARK
View Analyst & Ambassador Comments
Go to original news
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.

REGULATORY FDA

#cgm

#closed loop

View Analyst & Ambassador Comments
Go to original news
Feb 15,2018

DreaMed Diabetes Receives CE Mark for Platform for the Management of Type 1 Diabetes

DreaMed Diabetes, developer of diabetes management solutions, announced today that it received CE Mark for the Advisor Pro decision-support platform for assisting healthcare professionals in the management of Type 1 diabetes.

REGULATORY CE MARK
View Analyst & Ambassador Comments
Go to original news
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.

REGULATORY FDA

#cgm

#closed loop

View Analyst & Ambassador Comments
Go to original news
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.

REGULATORY FDA

#bgm

View Analyst & Ambassador Comments
Go to original news
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.

REGULATORY FDA

#cgm

View Analyst & Ambassador Comments
Go to original news
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.

REGULATORY FDA

#cgm

View Analyst & Ambassador Comments
Go to original news
Apr 30,2018

Tandem Diabetes Care Receives CE Mark for t:slim X2 Insulin Pump

Tandem Diabetes Care®, Inc. (NASDAQ: TNDM) today announced receipt of CE mark approval for the t:slim X2™ Insulin Pump with Dexcom G5® Mobile continuous glucose monitoring (CGM) integration. The Company plans to begin commercial sales of the pump in select international markets beginning in the second half of 2018. The Company has been commercializing its touchscreen insulin pumps in the United States since 2012, and received U.S. Food and Drug Administration (FDA) approval of the t:slim X2™ Insulin Pump with Dexcom G5 Mobile CGM integration in August 2017.

REGULATORY CE MARK

#cgm

View Analyst & Ambassador Comments
Go to original news
Jun 25,2018

Medtronic Receives CE Mark for MiniMed 670G Hybrid Closed Loop System

Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced it has received CE (Conformité Européenne) Mark for the MiniMed(TM) 670G hybrid closed loop system - the first and only system to automate and personalize the delivery of basal insulin 24 hours a day1. The system is CE Mark approved for the treatment of people with type 1 diabetes 7 years of age and older with ongoing studies to expand the indication to additional patient populations.

REGULATORY CE MARK

#closed loop

View Analyst & Ambassador Comments
Go to original news
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.

REGULATORY FDA

#insulin pump

View Analyst & Ambassador Comments
Go to original news
Subscribe to REGULATORY