Welldoc Archives - Medical Design Sourcing

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

The BlueStar platform. [Image from Welldoc]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 on continuous glucose readings.

BlueStar can now offer dose recommendations based on the most recent glucose reading and rate of change from a compatible CGM. This feature enhances BlueStar’s existing digital coaching capabilities for guiding dietary and lifestyle decisions in diabetes management.

Get the full story at our sister site, Drug Delivery Business News.

FDA clears Welldoc BlueStar for personalized bolus insulin dosing recommendations

The BlueStar platform. [Image from Welldoc]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.

Get the full story at our sister site, Drug Delivery Business News.

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 of ATTD 2022:

Dexcom’s G7 is accurate in pediatric T1D patients

Dexcom (Nasdaq:DXCM) published new data highlighting the accuracy of the next-generation G7 continuous glucose monitor in children.

The study, published in the Journal of Diabetes and Scientific Technology, evaluated the G7 CGM in children and adolescents with type 1 diabetes. G7, which last month won CE mark approval, remains under FDA 510(k) review.

Get the full story at our sister site, Drug Delivery Business News.

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 insulin. For all participants and subgroups examines, time in range and the glucose management indicator (GMI) improved significantly, demonstrating that the combination could improve type 2 diabetes management and glycemic control.

Get the full story at our sister site, Drug Delivery Business News.

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.

Get the full story at our sister site, Drug Delivery Business News.

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 data every five minutes.

Get the full story at our sister site, Drug Delivery Business News.

FDA clears Welldoc diabetes software

Welldoc announced today that it received FDA clearance for an additional feature of its BlueStar Rx software for users of long-acting insulin.

Patients with diabetes who are prescribed the insulin adjustment program (IAP) as part of BlueStar can now receive real-time adjustments to their insulin with the newly cleared feature, according to a news release.

Columbia, Md.-based Welldoc touts BlueStar as the only FDA-cleared and reimbursable software as a medical device that works with a patient’s existing devices. It can be integrated with blood glucose monitors, blood pressure cuffs or fitness trackers to deliver 24/7 real-time feedback.

“With BlueStar’s insulin adjustment program, a provider prescribes a safe starting dose of insulin for his or her patient, and BlueStar does the rest,” Welldoc chief medical officer Dr. Mansur Shomali said in the release. “The patient no longer has to wait to talk to his or her provider to adj…