Senseonics gets next-gen approval
By HME News Staff
Updated 10:03 AM CST, Tue February 15, 2022
GERMANTOWN, Md. – Senseonics has announced approval by the U.S. Food and Drug Administration for its next-generation Eversense E3 CGM System. The Eversense E3, which includes proprietary sacrificial boronic acid technology to extend longevity to six months, is planned to be available in the U.S. through Ascensia Diabetes Care, the company’s global commercial partner, beginning in the second quarter of 2022. “We repeatedly hear from our patients with diabetes that what they desire is a long-lasting sensor that is also highly accurate,” said Satish Garg, M.D., professor of medicine and director of the Adult Diabetes Program at the Barbara Davis Center of the University of Colorado, and the principal investigator of the PROMISE Study1, which formed the basis for the FDA approval. “The next generation Eversense E3 System delivers on both. This is another step forward for patients who desire to manage their diabetes with all the advantages of the Eversense CGM with the fully implantable sensor.” With approval for the Eversence E3, Senseonics is now providing a financial outlook for 2022, including global net revenue of $14 million to $18 million.
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