One Drop said today that it won 510(k) clearance from the FDA and CE Mark clearance for its One Drop | Chrome blood glucose monitoring system. The system is a part of One Drop | Premium, which the company touts as the 1st-ever monthly subscription service for affordable diabetes care.
The subscription service includes unlimited blood glucose testing supplies and 24/7 in-app support from diabetes experts, according to the company. One Drop claimed that diabetes costs $825 billion per year in direct costs, healthcare services, loss of productivity, and disability, while its service costs $39.95 or less each month without insurance.
The One Drop | Premium service also includes a cloud-bates diabetes management app for iOS and Android, which allows subscribers and their healthcare providers to monitor real-time and historical blood glucose data.
“One Drop is designed by people with diabetes for people with diabetes, and One Drop | Chrome is a perfect embodiment of our vision,” CEO & founder, Jeff Dachis said in prepared remarks. “We’re transforming the diabetes management experience by designing empowering, beautiful products people love to use, while also delivering outstanding evidence-based results.”
The company also touted a preliminary analysis of recent data collected from its users over the course of 4 consecutive weeks. The data showed that users consistently tracked their food and blood glucose levels, increased their average number of in-range blood glucose readings by 40%, and reduced their average percentage of high blood glucose readings from 18.5% to 3.7%.
“It’s crucial that any diabetes solution drives evidence-based results,” said Dachis. “With One Drop | Premium, we are delivering a well-designed, evidence-based diabetes solution that offers accessible, affordable, scalable, comprehensive care to anyone, anywhere in the world. In doing so, we empower everyone with diabetes to make better choices, lead fuller lives, and achieve meaningful improvements in their health outcomes.”
The post One Drop wins FDA nod, CE Mark for mobile blood glucose monitor appeared first on MassDevice.