Welldoc Attains Milestone: Bluestar®, The Diabetes Platform, Secures 10th FDA 510(K) Clearance

Wednesday, August 16, 2023

Welldoc®, a pioneer in digital health advancements for chronic care, has proudly announced a significant milestone—receiving its 10th 510(k) clearance from the Food and Drug Administration (FDA) for its renowned diabetes management solution, BlueStar®. This achievement firmly establishes Welldoc as a frontrunner in the realm of diabetes technology.

This recent 510(k) clearance represents a noteworthy leap forward for BlueStar®, enabling the seamless integration of connected insulin dosing data into personalized bolus insulin dosing recommendations. Expected to be available for commercial use in 2024, this novel feature promises to elevate the capabilities of diabetes management.

The attainment of the 10th 510(k) clearance underlines Welldoc's unwavering commitment to propelling digital health innovation. With a robust history of clinical validation in supporting intricate chronic conditions, Welldoc acknowledges the pivotal role that insulin dosing plays in effective diabetes management.

Harnessing their state-of-the-art software, Welldoc empowers adults living with diabetes, caregivers, and healthcare providers by delivering crucial data and insights. In addition to securing 10 510(k) clearances for its diabetes-centric digital health platform, Welldoc has cultivated a remarkable intellectual property portfolio comprising 40 patents that attest to their prowess in cutting-edge AI and revolutionary technology. Moreover, Welldoc's contributions are substantiated by an extensive collection of over 70 clinical publications, further solidifying their impactful presence in the healthcare landscape.

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