Eversense
The continuous glucose monitoring system can be used to measure glucose levels in adults with diabetes for up to six months.
The arrangement comes alongside new eight-figure investments into the CGM maker, whose business looked to be in dire straits earlier this year.
Senseonics initiated the recall voluntarily in September after receiving reports of 24 sensors that had stopped functioning prematurely.
The FDA approval closes a gap with competitors Dexcom and Abbott, as well as setting the company up for entry into the Medicare market.
The Eversense Bridge program is geared toward patients with high-deductible insurance plans or plans that don't cover the full cost of Eversense CGM, and allows them to purchase the system for $99.
Users of the Eversense CGM will be able to transfer their data to Glooko's online diabetes management platform.
Also: Senseonics' Eversense is cleared for use during an MRI; Warby Parker's AR app update.