Aug 09,2016

Senseonics Reports Topline Accuracy Results from U.S. Pivotal Study of Eversense CGM System.

enseonics Holdings, Inc. (NYSE-MKT: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 announced topline results of the PRECISE II (A Prospective, Multicenter Evaluation of the Accuracy of a Novel Continuous Implanted Glucose Sensor) Clinical Investigation. Results from the 90 adults with diabetes generated over 16,000 comparative glucose data points and demonstrated strong accuracy for the 90-day continuous wear period with a mean absolute relative difference (MARD) of 8.8% across the 40-400 mg/dL range when compared to YSI blood reference values.

CLINICAL STUDY

#cgm

View Analyst & Ambassador Comments
Go to original news
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.

REGULATORY FDA

#cgm

View Analyst & Ambassador Comments
Go to original news
Sep 02,2016

Nemaura Medical Inc., sign Letter of Intent with Shenzen CAS Health Corp, for potential JV and manufacture of their sugarBEAT® system

Nemaura Medical Inc., a medical device company developing a minimally invasive, needle-free, wireless CGM patch known as sugarBEAT®, today announced that it has signed a letter of intent (LOI) with a Chinese Corporation, Shenzen CAS Health Corporation Limited, which is a partially owned subsidiary of the Chinese Academy of Science. The letter of intent covers three potential joint venture arrangements relating specifically to sugarBEAT® including (a) setting up a joint venture company to distribute in China, (b) setting up a manufacturing facility in China and (c) obtaining CFDA approval.

COLLABORATION PARTNERSHIP

#institution

#cgm

View Analyst & Ambassador Comments
Go to original news
Oct 25,2016

Medtronic launches Android app for MiniMed Connect

More than a year after Medtronic released its MiniMed Connect system, which connects an insulin pump and affiliated CGM to a smartphone app, the company has launched an Android version of the MiniMed Connect app.

PRODUCT

#mobile app

#cgm

#insulin pump

View Analyst & Ambassador Comments
Go to original news
Oct 27,2016

Senseonics submits Eversense® Continuous Glucose Monitoring system PMA to FDA

Senseonics Holdings, Inc. (NYSE-MKT: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 announced that it has submitted to the U.S. Food and Drug Administration (FDA) a Premarket Approval (PMA) application for its Eversense® CGM system.

PRODUCT

#cgm

View Analyst & Ambassador Comments
Go to original news
Nov 11,2016

Presentation of PRECISE II U.S. Pivotal Trial Data of the Eversense CGM System at the 16th Annual Diabetes Technology Meeting

Senseonics Holdings, Inc. (NYSE-MKT: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, presented results of the PRECISE II U.S. pivotal trial at this week’s 16th Annual Diabetes Technology Meeting in Bethesda, Maryland. Study results show 93% of readings were within 20% of the YSI reference. The detection rate at the hypoglycemia alert setting (70 mg/dL) was 93% and 96% at the hyperglycemia alert setting (180 mg/dL).

CLINICAL STUDY

#cgm

View Analyst & Ambassador Comments
Go to original news
Nov 14,2016

With Health Canada approval, Dexcom G5® Mobile CGM System is the First Medical Device in North America for Making Daily Diabetes Decisions Without Painful Fingersticks

Dexcom, the leader in continuous glucose monitoring (CGM) for patients with diabetes, announced today that Health Canada has approved its Dexcom G5 Mobile CGM system for "non-adjunctive" use by people with diabetes aged 2 years and older. DexCom, Inc.

PRODUCT

#cgm

View Analyst & Ambassador Comments
Go to original news
Dec 07,2016

Medtronic, Fitbit partner to integrate data from CGM device, activity tracker into one app

Medical device maker Medtronic has teamed up with Fitbit to integrate physical activity data with blood glucose levels into one streamlined application. People living with type 2 diabetes who use Medtronic's iPro2 continuous glucose monitoring system and its companion app, iPro2 myLog, will now be able to have their Fitbit data automatically synced to the app, enabling them to easily see the connection between their exercise and glucose levels.

COLLABORATION PARTNERSHIP

#connected device

#cgm

View Analyst & Ambassador Comments
Go to original news
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.

REGULATORY FDA

#cgm

View Analyst & Ambassador Comments
Go to original news
Dec 02,2016

Senseonics Expands Distribution Agreement with Roche

Senseonics Holdings, Inc. (NYSE-MKT: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 announced it has expanded its exclusive distribution agreement with Roche to include all of Europe, the Middle East and Africa (EMEA), excluding Scandinavia, Finland and Israel. In May of this year, Senseonics signed an exclusive distribution with Roche for the commercialization of Senseonics’ Eversense® Continuous Glucose Monitoring System in Germany, Italy and the Netherlands.

COLLABORATION PARTNERSHIP

#product & service

#cgm

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