Products / Population Health & Clinical Programs

Welldoc

Public facts

FDA-cleared diabetes digital therapeutic

Healthcare AI company whose Welldoc Diabetes / BlueStar software is an FDA-cleared medical device for adult type 1 and type 2 diabetes; other Welldoc apps are general-wellness products.

Visit welldoc.com

Overview

Welldoc sells clinically validated, AI-enabled cardiometabolic software to health organizations, including branded and white-label deployments and enhanced weight management. The homepage states that Welldoc Diabetes and Welldoc Diabetes Rx are FDA-cleared medical devices for healthcare providers and their adult patients with type 1 or type 2 diabetes; other Welldoc app products are not FDA-cleared and are for general wellness and education. BlueStar is the historical FDA-cleared product name (multiple 510(k)s, including type 1 and CGM features). Welldoc also publishes partnership models that flex to the buyer rather than a single SKU.

Why it matters Welldoc is one of the few diabetes apps that is FDA-cleared as a medical device (BlueStar/Diabetes), including white-label use by plans and systems.

Target buyer: Health plans, health systems, life-science partners, and employers/payers that want FDA-cleared diabetes software, including white-label.
Pricing model: Not published; partnership and enterprise contracts; Older Truven/ADA analyses of PMPM savings exist in secondary coverage; they are not a current Welldoc price list and are not used as fees here. CVS weight-management footnotes on the solutions page are CVS data-on-file, not Welldoc list prices.
Availability: National
Research: Last researched 2026-08-23; Public facts category

Key features

FDA-cleared Welldoc Diabetes / Diabetes Rx (BlueStar lineage) for adult T1D and T2D
AI coaching and diabetes data capture/transmission to the care team
CGM and glucose-device integration (documented in clearances and studies)
Cardiometabolic ‘connect conditions’ platform
Branded and white-label options
Enhanced weight-management offering (solutions page; CVS Healthspire footnotes)

Integrations

Healthcare provider workflows (indicated users include HCPs and adult patients)
CGM/BGM devices (e.g., Dexcom G6 named in published research)
Lilly connected-insulin collaboration (historical news; commercialization by Lilly)
White-label / partner branding

Overview

Welldoc (welldoc.com) markets healthcare-ready AI and cardiometabolic connected care. The legally important distinction is on the homepage references: Welldoc Diabetes and Welldoc Diabetes Rx are FDA-cleared medical devices for healthcare providers and adult patients with type 1 or type 2 diabetes. Other Welldoc apps are non-cleared wellness/education products.

Company news and DailyMed labeling describe BlueStar (originally DiabetesManager / DiabetesManager-Rx) as the cleared product, with later type 1 and CGM-related clearances. Indication language on DailyMed (type 2, age 21+ in an older label) has been expanded in later clearances; buyers should use the current FDA labeling, not this summary, for regulatory scope.

Welldoc is based in Columbia, Maryland per historical news. It describes itself as a Digital Therapeutics Alliance founding member in older releases.

Key Capabilities

Prescription digital diabetes self-management (cleared device).
Motivational, behavioral, and educational coaching messages.
Secure capture, storage, and transmission of diabetes data.
Insulin-related features in some configurations (titration support, bolus calculator) per company news—confirm current cleared indications.
Broader cardiometabolic insights platform.
White-label and partnership packaging.
Weight-management solution referenced with CVS Healthspire analytics footnotes (18.5% average weight loss among engaged AOM users in a 2024 CVS client group—CVS data, not a Welldoc RCT).

Integrations & Ecosystem

Designed to sit with providers, payers, and health systems. Published Dexcom G6 sync appears in independent research. A 2021 Lilly collaboration aimed to embed BlueStar capabilities in Lilly connected pens; Lilly was to commercialize the pen platform.

Pricing

No public PEPM. Sold as partnerships and branded/white-label deals.

Notes & Limitations

Do not call non-cleared Welldoc apps FDA-cleared.
BlueStar is not a substitute for licensed professional care (label).
Current age/indication text must be verified against the latest 510(k)/label.
Solutions-page CVS weight outcomes are partner data-on-file.

Sources

Tags: population health · digital therapeutic · FDA-cleared · diabetes · white-label