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welldoc

Welldoc gets FDA nod for CGM-guided insulin bolus dosing software

August 23, 2023 By Sean Whooley

Welldoc BlueStar diabetes management platform

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 […]

Filed Under: Business/Financial News, Diabetes, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Patient Monitoring, Regulatory/Compliance, Technology Tagged With: FDA, welldoc

FDA clears Welldoc BlueStar for personalized bolus insulin dosing recommendations

August 15, 2023 By Sean Whooley

Welldoc BlueStar diabetes management platform

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) […]

Filed Under: Diabetes, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Patient Monitoring, Regulatory/Compliance, Technology Tagged With: FDA, welldoc

CGMs, insulin pumps and more: the biggest diabetes news to come out of ATTD 2022

May 3, 2022 By Sean Whooley

ATTD 2022 diabetes tech

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 […]

Filed Under: Auto-injectors, Business/Financial News, Clinical Trials, Diabetes, Drug-Device Combinations, Featured, Patient Monitoring Tagged With: abbott, Ascensia Diabetes Care, Beta Bionics, CamDiab, dariohealth, Dexcom, Diabeloop, Insulet, Medtronic, One Drop, Tandem Diabetes Care, Walmart, welldoc, Ypsomed

Welldoc says CGM, digital health platform combination provides better glycemic outcomes

April 28, 2022 By Sean Whooley

welldoc

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 […]

Filed Under: Clinical Trials, Diabetes, Drug-Device Combinations, Featured, Patient Monitoring, Technology Tagged With: Dexcom, welldoc

Welldoc wins expanded FDA clearance for BlueStar insulin dosing platform

September 22, 2021 By Sean Whooley

welldoc

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 […]

Filed Under: Auto-injectors, Diabetes, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Patient Monitoring, Regulatory/Compliance Tagged With: FDA, welldoc

Welldoc, Dexcom expand diabetes management tech partnership

April 5, 2021 By Sean Whooley

Welldoc Dexcom

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 […]

Filed Under: Business/Financial News, Diabetes, Drug-Device Combinations, Featured, Patient Monitoring, Pharmaceuticals Tagged With: Dexcom, welldoc

Lilly to add Welldoc app to future insulin pen

February 25, 2021 By Nancy Crotti

Eli Lilly

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 […]

Filed Under: Diabetes, Drug-Device Combinations, Featured, Pharmaceuticals, Regulatory/Compliance Tagged With: Eli Lilly & Co., elililly, welldoc

LifeScan inks deal to broker institutional sales for OneTouch Reveal Plus

October 2, 2019 By Sean Whooley

LifeScan OneTouch app

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 […]

Filed Under: Diabetes, Featured, Mergers & Acquisitions, Patient Monitoring Tagged With: lifescan, welldoc

Voluntis, WellDoc partner to offer digital diabetes management system

January 16, 2018 By Sarah Faulkner

Voluntis Insulia

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 […]

Filed Under: Diabetes, Drug-Device Combinations, Featured, mHealth (Mobile Health), Pharmaceuticals Tagged With: Voluntis, welldoc

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