Israel-based DarioHealth has been granted 510(k) clearance for a version of its Blood Glucose Monitoring System that, alongside the Dario app, is compatible with iPhone 7, 8, and X, according to a statement from the company.
“We’ve been working tirelessly to bring forth a solution that would meet the rigorous standards required to achieve the FDA clearance,” DarioHealth CEO and Chairman Erez...
Baltimore, Maryland-based WellDoc, which makes a digital platform for chronic disease management, is teaming up with consumer electronics giant Samsung to offer an integrated tool for people living with diabetes.
BlueStarC will be available directly to consumers under Samsung’s newly launched mobile health app Samsung Health (formerly known as S Health). The diabetes management app is the third...
Delivering on a promise spoken just last week, DarioHealth announced partnerships today that will allow customers in the United States who use the company’s digital diabetes monitoring system to have their products reimbursed by insurance.
All third party insurers were not named, but the company said it had signed alliance agreements with partners across the country who will be able verify...
Digital diabetes management company Omada Health has brought on federal policy veteran Lucia Savage as their new Chief Privacy and Regulatory Officer. Savage, who previously worked as Chief Privacy Officer at the Office of the National Coordinator for IT, will lead Omada’s legal and compliance team. In her new role, Savage will lead Omada’s regulatory strategy and ensure the privacy and security...
The US Food and Drug Administration has given the green light for a non-prescription version of BlueStar, WellDoc’s mobile diabetes management platform.
Through this 510(k) class II clearance, WellDoc will now offer BlueStar and BlueStar Rx, allowing the company to offer the product through more channels. Both versions analyze diabetes data entered by the patient, comparing past data trends to...
Mountain View, California-based Glooko is collaborating with Danish pharmaceutical company Novo Nordisk to develop a digital diabetes management platform.
The non-exclusive partnership, developed and branded by both companies, will combine Glooko’s digital capabilities and Novo Nordisk’s deep knowledge of diabetes. Glooko offers a mobile, cloud-based platform for people with diabetes to track and...
The FDA has cleared the wireless integration of one of Johnson and Johnson subsidiary LifeScan’s blood glucose monitoring systems and WellDoc’s digital diabetes management platform for people with type 2 diabetes.
The two companies originally teamed up in March of this year. The integrated system consists of OneTouch Verio Flex, LifeScan’s Bluetooth smart blood glucose monitoring system and...
