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.

REGULATORY FDA

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Nov 07,2018

Nemaura Successfully Develops Predictive Algorithms and Alarm Functionality for Continuous Glucose Monitor SugarBEAT®

Nemaura Medical Inc. (NASDAQ: NMRD), a medical technology company developing sugarBEAT® as a non-invasive affordable and flexible Continuous Glucose Monitor (CGM) for use by people with diabetes and pre-diabetics, today announced the successful development of predictive algorithms that will allow the inclusion of alarms in its sugarBEAT® CGM. Results indicate the alarm functionality can predict glucose level 5 minutes in advance with 98% accuracy, 10 minutes in advance with 95% accuracy and 15 minutes in advance with 90% accuracy.

PRODUCT

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Nov 20,2018

Nemaura Signs License and Distribution Agreement for SugarBEAT® Commercial Launch in Qatar

Nemaura Medical Inc. (NASDAQ: NMRD), a medical technology company developing sugarBEAT® as a non-invasive, affordable and flexible Continuous Glucose Monitor (CGM) for use by persons with diabetes and pre-diabetics, today announced that it has signed an exclusive license and distribution agreement with Al-Danah Medical Co. for the commercial launch of sugarBEAT® in Qatar in readiness for 2019 launch.

COLLABORATION PARTNERSHIP

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Dec 18,2018

Nemaura Publishes Positive Data from SugarBEAT® FDA Clinical Trial

Nemaura Medical Inc., a medical technology company developing sugarBEAT® as a non-invasive, affordable and flexible Continuous Glucose Monitor (CGM) for use by people with diabetes and pre-diabetics, today published clinical data from its recently completed study intended to support a De Novo submission to the U.S Food & Drug Administration (“FDA”) for approval of its sugarBEAT® product.

CLINICAL STUDY

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Dec 21,2018

Nemaura Announces Completion of Key Stages of Technical File Review for SugarBEAT® CE Mark Approval

Nemaura Medical Inc., a medical technology company developing sugarBEAT® as a non-invasive, affordable and flexible Continuous Glucose Monitor (CGM) for use by people with diabetes and pre-diabetics, today announced that two of the three key stages for the CE Mark approval of sugarBEAT® have been completed.

PRODUCT

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Jan 14,2017

CMS will cover some CGMs, starting with Dexcom G5

The Centers for Medicare and Medicaid Services has deemed certain therapeutic continuous blood glucose meters (CGMs) as durable medical equipment and thus are eligible for coverage. Eligible devices must fit several definitions: they must be a class III, FDA-approved device, and they must be CGMs that measure blood glucose levels periodically by using sensors, a receiver and transmitter and eliminate the need for blood glucose strips, informing patients and their doctors in treatment decisions. One such device does make the cut: the Dexcom G5 Mobile, and it’s currently the only one that falls within the CMS’s new benefit category classification.

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Jan 10,2017

Dexcom G5® Mobile Continuous Glucose Monitoring (CGM) System Now Compatible on Android Smart Phones and Watches in Europe

DexCom, Inc. (NASDAQ:DXCM), the leader in Continuous Glucose Monitoring (CGM) for patients with diabetes, announced today that its G5 Mobile CGM System is now compatible on Android smart devices throughout Europe and South Africa. This new platform will be launching into select European countries today and continue throughout the fourth quarter of 2017.

PRODUCT

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Jan 23,2017

Dexcom Launches Dexcom CLARITY® Diabetes Management Solution in EMEA

Dexcom announced the general availability of the Dexcom CLARITY diabetes management solution in EMEA, enhancing user data visibility and analysis. Dexcom CLARITY works with the Dexcom CGM System by automatically sending a patient's CGM data to a secure cloud-based system that can easily be accessed by the patient's health care professional. The software platform allows for automated summaries and reports for physicians, empowering them to help their patients better manage their diabetes.

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Feb 10,2017

Sano Intelligence is working on a wearable continuous glucose monitor in the form of an adhesive patch and companion app

Sano Intelligence is working on a wearable continuous glucose monitor in the form of an adhesive patch and companion app – but it won't be marketed, at least initially, to people with diabetes. Sano shared new details about their device with Gizmodo, who cast some doubt on the wisdom of a CGM for wellness. The company is marketing the device as a product for “metabolic insight” for people who do not have diabetes, thereby dodging the purview of the FDA. Sano wants to get the device into beta release this year, and claims it would offer the everyday person data that would provide “personalized metabolic insights in real-time” to help them figure out how what they eat affects their blood sugar and metabolism.

PRODUCT

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Feb 15,2017

Real-world data shows Abbott Freestyle users scan often, and that correlates with lower HbA1Cs

The real world data, mostly of European users, spans two years and includes data from 50,000 readers and 285,000 sensors . It represents 86.4 million monitoring hours and 63.8 million distinct scans. What Abbott found was that users of the FreeStyle Libre system scan about 16 times per day on average. But even more interesting for the company are the other health benefits that correlate with increased scanning. Although they aren't able to prove causation, Abbott saw that there was a strong correlation between number of scans per day, time below 55 mg/dL, and estimated A1C.

CLINICAL STUDY

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