Welldoc announced today that it won the 11th FDA 510(k) clearance for its BlueStar digital diabetes management platform. The clearance comes just a week after BlueStar received its 10th FDA clearance for using connected insulin dosing data in personalized bolus insulin dosing recommendations. Welldoc’s newest clearance enables BlueStar to provide bolus insulin dose recommendations based […]
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FDA clears Welldoc BlueStar for personalized bolus insulin dosing recommendations
Welldoc announced today that it received the 10th FDA 510(k) clearance for its BlueStar diabetes digital health solution. The latest regulatory nod enables BlueStar to use connected insulin dosing data in personalized bolus insulin dosing recommendations. Columbia, Maryland-based Welldoc aims to make this enhanced functionality available commercially in 2024. “The receipt of our 10th 510(k) […]
CGMs, insulin pumps and more: the biggest diabetes news to come out of ATTD 2022
All kinds of technologies were on display at the Advanced Technologies & Treatments for Diabetes (ATTD) conference in Barcelona last week. From continuous glucose monitoring (CGM) to automated insulin delivery, with plenty in between, a number of companies shared positive data for their diabetes offerings. Here are five of the biggest stories to come out […]
Welldoc says CGM, digital health platform combination provides better glycemic outcomes
Welldoc said that its combination of real-time continuous glucose monitoring (CGM) and digital health impacts glucose control in type 2 diabetes. Columbia, Maryland-based Welldoc presented data at the Conference on Advanced Technologies & Treatments for Diabetes (ATTD) from a study of real-time CGM and digital health in individuals with type 2 diabetes not treated with […]
Welldoc wins expanded FDA clearance for BlueStar insulin dosing platform
Welldoc announced today that it received another FDA 510(k) clearance for its BlueStar diabetes treatment platform. Columbia, Maryland-based Welldoc’s new clearance for BlueStar — the ninth in total — expands insulin dosing support to most types of insulin, including bolus and premixed insulin titration for type 2 diabetes. Previous FDA clearances include in June 2020 […]
Welldoc, Dexcom expand diabetes management tech partnership
Welldoc announced today that it will offer its BlueStar digital health solution with Dexcom’s G6 CGM system as a single platform. Columbia, Md.-based Welldoc’s FDA-cleared BlueStar system offers guidance to individuals through the self-management of diabetes, while Dexcom’s G6 continuous glucose monitoring (CGM) system measures glucose levels just beneath the skin’s surface and wirelessly transmits […]
Lilly to add Welldoc app to future insulin pen
Eli Lilly (NYSE:LLY) and Welldoc announced a collaboration and licensing agreement to integrate Welldoc’s software into Lilly’s connected insulin pens, which are in development. Lilly and Welldoc will create a new version of Welldoc’s BlueStar insulin management software, which will integrate insulin dosing data for several Lilly insulins. The BlueStar app has FDA 510(k) clearance for […]
LifeScan inks deal to broker institutional sales for OneTouch Reveal Plus
LifeScan said yesterday that it entered into an agreement with Willis Towers Watson to expand the commercialization of its OneTouch Reveal Plus digital diabetes therapy system. The companies hope the collaboration will see LifeScan and Willis Towers Watson combine to support self-insured employers in helping their employees and dependents manage diabetes. The OneTouch Reveal Plus […]
Voluntis, WellDoc partner to offer digital diabetes management system
Voluntis has inked a commercial deal to combine its insulin titration tech with WellDoc‘s coaching platform to create a digital management solution for people with Type II diabetes. Cambridge, Mass.-based Voluntis has developed an FDA-approved system, Insulia, which provides automated insulin dose recommendations that can be monitored remotely by a patient’s healthcare team. WellDoc’s BlueStar […]
