Medical device and MedTech insights, news, tips and more
Welldoc Receives 10th 510(k) Clearance from FDA for Award-Winning Diabetes Platform BlueStar®
August 17, 2023
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
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.
See Full Press Release at the Source: Welldoc Receives 10th 510(k) Clearance from FDA for Award-Winning Diabetes Platform BlueStar®
Press Release by: Welldoc
Legacy MedSearch has more than 35 years of combined experience recruiting in the medical device industry. We pride ourselves on our professionalism and ability to communicate quickly and honestly with all parties in the hiring process. Our clients include both blue-chip companies and innovative startups within the MedTech space. Over the past 17 years, we have built one of the strongest networks of device professionals ranging from sales, marketing, research & , quality & regulatory, project management, field service, and clinical affairs.
We offer a variety of different solutions for hiring managers depending on the scope and scale of each individual search. We craft a personalized solution for each client and position with a focus on attracting the best possible talent in the shortest possible time frame.
Are you hiring?
Contact us to discuss partnering with Legacy MedSearch on your position.