Welldoc secures new FDA 510(k) clearance for BlueStar diabetes platform
24 Aug 2023
Drug Approval
The clearance will allow BlueStar to offer bolus insulin dose recommendations as per the latest glucose reading and rate of change from a compatible CGM device
Welldoc gets 11th US FDA 510(k) clearance for BlueStar platform. (Credit: isens usa on Unsplash)
Digital health company Welldoc has secured another 510(k) clearance from the US Food and Drug Administration (FDA) for its BlueStar platform, a digital health solution for diabetes.
BlueStar, the company’s flagship product, is said to help diabetes patients self-manage their care while improving connections to their healthcare team.
The latest FDA clearance will allow BlueStar to offer bolus insulin dose recommendations to patients. These will be as per the most recent glucose reading and rate of change from a compatible continuous glucose monitoring (CGM) device.
According to Welldoc, the feature improves BlueStar’s current digital coaching capabilities, which offer dietary and lifestyle advice and help people manage diabetes on their own.
The approval marks Welldoc’s 11th 510(k) clearance. It follows the company’s 10th 510(k) clearance announced earlier this month for BlueStar to use connected insulin dosing data in personalised bolus insulin dosing recommendations.
In addition, Welldoc is said to be the first company to get approval for a CGM-informed bolus calculator made exclusively for adults who manage their diabetes with several daily insulin injections.
Welldoc president and CEO Kevin McRaith said: “This 11th 510(k) clearance is a remarkable achievement for Welldoc and demonstrates our steadfast commitment to transforming chronic care.
“We are dedicated to creating new digital health capabilities which leverage the latest innovations like CGM to develop more connected and personalized solutions for individuals with complex health needs.”
The digital health firm’s chronic care platform offers support for pre-diabetes, diabetes, hypertension, heart failure, weight management, and mental health.
Additionally, Welldoc collaborates with health systems, health plans, and employers to expand care, improve health, and reduce costs.
In March this year, Astellas Pharma and Roche Japan signed an agreement to develop and commercialise the latter’s Accu-Chek Guide Me blood glucose monitoring system as a combined medical product with BlueStar.
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