Jan 19,2017

Eli Lilly gets FDA clearance for insulin dose calculator app

Updated with statement from Eli Lilly Indianapolis-based pharma company Eli Lilly recently recieved FDA 510K clearance for a new mobile app called Go Dose, a diabetes management and insulin dosing app for users of Humalog, Lilly's rapid-acting insulin. The clearance is for prescription use, but includes two versions of the app: Go Dose, for patients, and Go Dose Pro, for healthcare providers. "The Go Dose System, comprised of the Go Dose and Go Dose Pro applications, is for use in home and clinical settings to aid in the review, analysis, and evaluation of historical blood glucose test values to support type 2 diabetes mellitus management," the company writes in the submission document.

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Jan 19,2017

FDA clears WellDoc's non-RX version of BlueStar, its mobile diabetes management tool

The US Food and Drug Administration has given the green light for a non-prescription version of BlueStar, WellDoc’s mobile diabetes management platform. Through this 510(k) class II clearance, WellDoc will now offer BlueStar and BlueStar Rx, allowing the company to offer the product through more channels. Both versions analyze diabetes data entered by the patient, comparing past data trends to form personalized guidance and creating a summary of curated data analytics to the healthcare team for clinical decision support, but the non-prescription version will not feature the insulin calculator that the full version does.

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Apr 06,2017

Sanofi gets FDA clearance for insulin dose calculator app

Following in the footsteps of Eli Lilly and Roche, Sanofi has quietly received FDA clearance for a smartphone app with a built-in insulin dose calculator. According to FDA documents, the app, cleared at the end of March, is called My Dose Coach.

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May 01,2017

Amalgam Rx gets FDA nod for insulin titration app

AmalgamRx, a newly unstealthed company founded by WellDoc founders Ryan Sysko and Dr. Suzanne Clough, has received FDA clearance for iSage, an insulin titration algorithm. iSage is a prescription-only patient-facing iOS and Android app that works in conjunction with a web portal used by the doctor. The doctor sets target levels for insulin based on the patient’s glucose levels. Then the algorithm takes over. Patients can enter their blood glucose levels and iSage will change their insulin dosing levels based on the doctor’s plan and the entered values.

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Jun 07,2017

Dexcom Announces FDA Approval of G5 Mobile App for Android Devices

Dexcom is pleased to announce the Food and Drug Administration (FDA) approval of the Dexcom G5 mobile app for Android devices. Beginning in June, Android users will have access to the free app for the Dexcom G5 Mobile CGM System, allowing people with diabetes to view and monitor their glucose levels on their mobile devices to manage their diabetes in real time. The Dexcom G5 Mobile CGM System is the first and only CGM platform available for Android in the United States, complementing the 2015 iOS launch.

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Jul 20,2017

DarioHealth Receives U.S. FDA Clearance for Certain Leading Android Devices in the U.S.

DarioHealth Corp. (NASDAQ: DRIO), a leading global digital health company with mobile health and big data solutions, today announced that the United States Food and Drug Administration (FDA) has granted Pre-market Notification (510(k)) clearance for the Dario app on certain leading Android smart mobile devices (SMD).

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Aug 28,2017

Tandem Diabetes Care Announces FDA Approval and Launch of t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM Integration

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 and commercial launch of the t:slim X2™ Insulin Pump with Dexcom G5® Mobile continuous glucose monitoring (CGM) integration, the first sensor-augmented insulin pump approved to let users make treatment decisions without pricking their finger. The software featured on this pump will also be available to current t:slim X2 Pump users at no cost via remote software update, allowing them to add CGM integration to their existing pumps from home using a personal computer. Individual emails are being sent directly to t:slim X2 Pump customers with instructions on how to perform the update. The t:slim X2 Pump with Dexcom G5 Mobile CGM integration is approved for ages 6 and older.

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Sep 27,2017

Abbott's Freestyle Libre system becomes first CGM to be FDA cleared for use without fingersticks

Abbott Diabetes Care's Freestyle Libre Flash Glucose Monitoring System has been approved by the FDA.

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Nov 16,2017

Voluntis gets FDA clearance to add last two basal insulins to app

Medical device software company Voluntis has received an updated FDA clearance (as well as an updated CE mark) for its Insulia app , a "digital companion" app for people with Type 2 diabetes. Insulia offers realtime basal insulin dose coaching, and the new clearance makes the app usable with two additional brands of insulin: Basaglar and Tresiba. The app had already worked for users of Lantus, Levemir, and Toujeo.

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Jul 28,2016

Lilly-backed smartphone-enabled insulin pen gets FDA nod

Companion Medical, a stealthy San Diego-based company that received funding last year from Eli Lilly and Company, has received FDA 510(k) clearance for its Bluetooth-connected smart insulin pen and associated mobile app, called InPen.

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