Signos obtained FDA clearance for a glucose monitoring system targeting weight management, expanding CGM use beyond diabetes into consumer wellness. The system pairs Dexcom's Stelo continuous glucose monitor with a Signos app that sets individualized glucose range goals, tailors them over time, and uses AI to deliver personalized recommendations. Approval opens the possibility of HSA and FSA coverage and future insurance reimbursement. Signos offers a six-month plan for $129 that includes sensors and app access, converting real-time glucose data into actionable insights and tips for healthier lifestyle choices.
"Everyone deserves access to insights that help them live healthier, longer, more vibrant lives," Signos CEO Sharam Fouladgar-Mercer said in a press release. "Signos isn't just about data; it's about giving people ownership over their health and weight journeys in a way never before seen."
"This is the first-ever FDA clearance for a system for weight that isn't a pharmacological intervention, isn't a surgical intervention," Fouladgar-Mercer told STAT.
"world's first and only FDA-cleared app and CGM for weight management and wellness,"
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