Last month, WellDoc, a leading mHealth company, announced that the FDA cleared their diabetes management app BlueStar for 510(k) Class II clearance for a non-prescription version.
BlueStar helps those with type 2 diabetes get real-time guidance including instructions to get blood glucose in a safe range, tips, reminders, and calendars for dental appointments. It's worth noting that for insulin-dependent patients, BlueStar doesn't tell them how much insulin to administer. Rather, it focuses on providing personalized self-management guidance and helping manage extremes of blood glucose. There are also inputs for mood and diet which gives users a broad and comprehensive view of their health. And the app delivers reports to healthcare providers for continual monitoring by a professional.
BlueStar has been available by prescription for a few years, but now that it has over-the-counter status, the company hopes that it will reach a wider audience and become more integrated with healthcare systems. The path WellDoc is following is similar to AliveCor, which also brought its Kardia monitor to market as a prescription device first before seeking over-the-counter clearance. It has some advantages for digital health devices by helping reassure regulators and others of safety with an initial period of more controlled, prescription-only use.
In a statement, Nick Harsh, Well Doc's head of market access, said:
"We feel the optionality of multiple versions now greatly enhances the business potential for BlueStar by allowing more options for payers to adopt it and expand access across their networks ... This clearance provides payers broader opportunities to use a proven tool that has demonstrated significant clinical outcomes to help better serve their adult members living with type 2 diabetes."
This article originally appeared on iMedicalApps.com.