WellDoc receives FDA clearance for non-prescription version of diabetes management app

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WellDoc, a Columbia health care technology company, has received clearance from the U.S. Food and Drug Administration to sell a version of its diabetes management mobile application that does not require a prescription.

The new offering, which should be available by the end of March, significantly expands WellDoc's potential client base and opens up new options for developing the business, said Kevin McRaith, its president and CEO.


"I would describe this as significant, transformational for WellDoc in how our business model will be able to evolve in 2017 and beyond," McRaith said.

Founded in 2005, WellDoc has 30 employees in Maryland and 30 developers based in India.


WellDoc's BlueStar is a mobile application that helps people manage Type 2 diabetes. The new version is identical to the original program, now called BlueStar Rx, except that the prescription version includes an insulin calculator.

Rather than selling the tool directly to people with diabetes, WellDoc partners with organizations and companies that want to offer the program to their members or customers.

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LifeScan Inc., a subsidiary of Johnson & Johnson that makes blood glucose monitoring systems, is among WellDoc's largest partners. WellDoc announced plans in March to integrate the prescription version of its app into LifeScan products.

The partnership coincided with a $29 million Series B financing round from investors including Johnson & Johnson.

McRaith thinks the program will appeal to a broader range of businesses, health plans and health care companies now that it is possible to use the program without a doctor's note.

For example, McRaith said that following the announcement Thursday, he met with one of the largest retail pharmacies in the country about BlueStar. He declined to identify the company.

The new offering could also appeal to large companies that want to offer wellness programs to employees without requiring people to get a prescription, he said.

"The prevalence of Type 2 diabetes is so large, and everyone is trying to address it," McRaith said.