Last month, WellDoc, a leading mHealth company, announced that the U.S Food and Drug Administration (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. The app also delivers reports to health care 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 health care systems. The path WellDoc is following is similar to AliveCor who also brought their Kardia monitor to market as a prescription device first before seeking over-the-counter clearance. It does have 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.”