Feb 25,2019

Google launches drug disposal tool, first real-world clinical use of ML for diabetes-related diseases

Google has been busy recently. Just in the past week it has closed down its Google Fit website, launched a new drug disposal tool and announced the first clinical use of Verily’s machine learning tool for diabetic related diseases.

PRODUCT

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Feb 25,2019

Hygieia's cloud-based insulin titration app wins 510(k) clearance

Earlier this month, Hygieia’s d-Nav Insulin Guidance Service — an app that titrates insulin doses for individual Type 2 diabetes patients, regardless of their regimen type — received 510(k) clearance from the FDA.

REGULATORY FDA

#mobile app

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Feb 28,2019

Dexcom G6 users can ask Siri to read their glucose level

For folks managing their diabetes with Dexcom, Siri can now answer one more question: What is my glucose level? This morning Dexcom announced a slew of new companion app features for the Dexcom G6 continuous glucose monitoring system, including the ability for Siri to read a user’s glucose level out loud and display graphs directly on the lock screen.

PRODUCT

#mobile app

#cgm

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Feb 03,2019

Roche expands access for people with diabetes to innovative long-term continuous glucose monitoring technology with unique 6 months wear time

Roche announced today the extension of the collaboration and distribution agreement with Senseonics Holdings, Inc., a medical technology company focused on the development and commercialization of a longterm, implantable CGM system for people with diabetes. Under the terms of the agreement, Roche will continue its role as Senseonics’ exclusive distributor in Europe, the Middle East and Africa, excluding Scandinavia and Israel. The new agreement is expanded to include 17 additional countries including Brazil, Russia, India and China as well as selected markets in the Asia Pacific and Latin American regions and will run through January 31, 2021.

COLLABORATION PARTNERSHIP

#product & service

#cgm

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Feb 05,2019

BD Announces Results for 2019 First Fiscal Quarter; Reaffirms Fiscal 2019 Guidance

BD, a leading global medical technology company, today reported quarterly revenues of $4.160 billion for the first fiscal quarter ended December 31, 2018. This represents an increase of 35.1 percent from the prior-year period, which is primarily due to the acquisition of C. R. Bard. On a comparable, currency-neutral basis, revenues increased 5.2 percent over the prior-year period.

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Feb 07,2019

Nemaura Medical Announces Grant of U.S. Patent for SugarBEAT® Glucose Sensing Algorithm

Nemaura Medical Inc., a medical technology company focused on the development of SugarBEAT® as a non-invasive, affordable and flexible Continuous Glucose Monitor (“CGM”) for use by diabetics and pre-diabetics, today announced the grant of U.S. Patent 10,092,224, Cumulative Measurement of an Analyte.

PRODUCT

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Feb 08,2019

OneTouch® BGMS Accuracy Proven in New Long-Term Study

New research published in a leading diabetes technology journal shows the long-term clinical accuracy of the OneTouch Select Plus® blood glucose test strip platform and highlights the products’ consistently accurate performance. This is the latest study in a series of recent studies that confirm the OneTouch® brand blood glucose monitoring system accuracy.

CLINICAL STUDY

#bgm

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Feb 11,2019

Nemaura Announces Dr. Fred Schaebsdau to Lead Strategy and Business Development

Nemaura Medical, Inc. nemauramedical.com, a medical technology company focused on the development of SugarBEAT® as a non-invasive, affordable and flexible Continuous Glucose Monitor (CGM) for use by diabetics and pre-diabetics, today announced that Dr. Fred Schaebsdau, MD, PhD, MBA has joined Nemaura to lead strategy and business development. Dr. Schaebsdau will advance Nemaura’s commercial strategy for its planned launch of SugarBEAT® in Europe, and advise regarding its upcoming 510(k) submission to the United States Food and Drug Administration. He will also be named to Nemaura’s Scientific Advisory Board.

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Feb 12,2019

Nemaura Reports Third Quarter 2018 Financial Results

Nemaura Medical, Inc., a medical technology company focused on the development of SugarBEAT® as a non-invasive, affordable and flexible Continuous Glucose Monitor (CGM) for use by diabetics and pre-diabetics, yesterday reported financial results for the third quarter ended December 31, 2018.

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Feb 14,2019

t:slim X2 Insulin Pump First to Receive New ACE Pump Classification by FDA

Tandem Diabetes Care, Inc., a leading insulin delivery and diabetes technology company, today announced that the U.S. Food and Drug Administration (FDA) has classified the t:slim X2™ insulin pump as the first in a new device category called Alternate Controller Enabled Infusion Pumps (ACE pumps). Along with this authorization, the FDA is establishing criteria, called special controls, which outline requirements for assuring the accuracy, reliability, cybersecurity and clinical relevance of ACE pumps, as well as describe the type of studies and data required to demonstrate acceptable pump performance. The approved indication for the t:slim X2 pump states that the pump is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute, and confirm commands from these devices.

REGULATORY FDA

#insulin pump

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