Welldoc Receives 10th 510(k) Clearance from FDA for Award-Winning Diabetes Platform BlueStar®
New version of the BlueStar® digital health solution available with enhanced insulin dosing capabilities via automatic connected device data
COLUMBIA, Md.–(BUSINESS WIRE)–Welldoc®, a digital health leader revolutionizing chronic care, today announced the receipt of its 10th 510(k) clearance from the Food and Drug Administration (FDA) for its award-winning diabetes digital health solution, BlueStar®. This clearance reinforces Welldoc’s position as a leader in technology in diabetes management.
This 10th 510(k) clearance enables BlueStar to use connected insulin dosing data in personalized bolus insulin dosing recommendations. This enhanced functionality will be made available commercially in 2024.
“The receipt of our 10th 510(k) clearance is another milestone demonstrating Welldoc’s commitment to leading innovation in digital health. Welldoc has achieved a significant level of clinical validation in supporting complex chronic conditions,” said Kevin McRaith, President and CEO of Welldoc. “Insulin dosing is a critical piece to diabetes management, and now, Welldoc’s software has the power to deliver these important data and insights directly into the hands of adults living with diabetes, their caregivers and their healthcare providers.”
In addition to achieving 10 510(k) clearances for its digital health platform designed to support diabetes health, Welldoc has also built an IP portfolio of 40 patents for its advanced AI and first-in-class tech and currently has more than 70 clinical publications.
For more information regarding Welldoc’s 10th FDA clearance, go to: https://www.accessdata.fda.gov/cdrh_docs/reviews/K230813.pdf
About Welldoc
Welldoc®, a digital health leader revolutionizing chronic care, is integrating personalized, real-time and actionable insights into the daily lives of individuals living with chronic conditions, enabling improved health and outcomes. Welldoc’s comprehensive chronic care platform provides multi-condition support across pre-diabetes, diabetes, hypertension, heart failure, weight management and behavioral health. Welldoc’s flagship product, BlueStar®, an FDA-cleared digital health solution, guides individuals through the complicated journey of living with diabetes by enabling them to self-manage their care while enhancing connections to their healthcare team. Welldoc partners with health plans, health systems and employers with the goal of extending care, improving health and reducing costs. Welldoc continues to be recognized for our leadership, innovation and partnership across the healthcare industry. This year, Welldoc was named the “Best Overall Digital Health Company” by MedTech Breakthrough, and also received the Innovation and AI excellence awards from Business Intelligence Group. For more information, visit www.welldoc.com. Follow us on LinkedIn and Twitter.
Contacts
MacDougall Advisors
Megan Prock McGrath
781-235-3060
mmcgrath@macdougall.bio