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December 8, 2016

One Drop receives FDA clearance and CE mark approval

One Drop has received US Food and Drug Administration (FDA) 510(k) clearance and Conformité Européene (CE) mark approval for One Drop | Chrome, a blood glucose monitoring system that combines modern design with advanced medical and mobile technology.

One Drop has received US Food and Drug Administration (FDA) 510(k) clearance and Conformité Européene (CE) mark approval for One Drop | Chrome, a blood glucose monitoring system that combines modern design with advanced medical and mobile technology.

This system is available as part of One Drop | Premium, which is a monthly subscription service to offer affordable, accessible diabetes care, unlimited blood glucose testing supplies and 24/7 live in-app support from diabetes experts, for less than a monthly co-pay.

One Drop CEO and founder Jeff Dachis said: "One Drop is designed by people with diabetes for people with diabetes, and One Drop | Chrome is a perfect embodiment of our vision.

"We're transforming the diabetes management experience by designing empowering, beautiful products people love to use, while also delivering outstanding evidence-based results."

Diabetes impacts nearly 500 million people across the world and costs $825bn per year due to direct costs, healthcare services, loss of productivity, and disability.

These expenses put a financial burden on both individuals and governments. One Drop | Premium is claimed to reduce these costs.

For $39.95 or less per month (without insurance), the One Drop | Premium monthly subscription service provides One Drop | Chrome with Unlimited Testing Supplies, One Drop | Mobile, One Drop | Experts for Anytime Care.

One Drop | Chrome with Unlimited Testing Supplies not only meets the highest standards of clinical accuracy, but it also wirelessly transmits blood glucose data directly to the cloud via the One Drop | Mobile app.

Unlimited blood glucose test strips are delivered on-demand directly to the doors of One Drop | Premium subscribers with no prescriptions, insurance and appointments.

One Drop | Experts moves diabetes education out of the clinic and into the lives of people with diabetes. Each One Drop | Premium subscriber has his/her own certified diabetes educator available 24/7 for guidance, support, and anytime care.

Experts deliver personalised digital therapeutics programmes to help people with diabetes define and achieve their health management goals.

Subscribers can communicate with their experts anytime via in-app chat; all data recorded in the app is available to experts in real-time, thereby enabling them to offer relevant behavioral guidance in the moments when subscribers require.

One Drop | Mobile is a cloud-based diabetes management solution delivered entirely through mobile app on iOS and Android.

One Drop | Mobile offers real-time and historical blood glucose data and analytics to subscribers and their healthcare providers, enabling both to see relationships between particular health behaviours and health outcomes.

"We're transforming the diabetes management experience by designing empowering, beautiful products people love to use, while also delivering outstanding evidence-based results."

One Drop | Mobile also includes a Apple WatchOS app for logging and analysing diabetes data on the go.

It is claimed to be the only diabetes management platform that offers comprehensive self-care, peer-support, and expert support all in one place.

One Drop | Chrome will be sold exclusively by One Drop on iOS, Android, and at http://onedrop.today and http://store.apple.com.


Image: The One Drop | Chrome blood glucose monitor. Photo: Courtesy of One Drop.

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