Senseonics Eyes Longer-Term CGM Sensor

Senseonics had all the right ingredients to pull in strong earnings in 2019. The continuous glucose monitoring (CGM) specialist had a strong product on the market and significant reimbursements – yet the company fell short of expectations. Now Senseonics is coming into 2020 with all guns firing. The Germantown, MD-based company is making headway in developing a longer-term CGM sensor. FDA gave Senseonics the greenlight to have a subgroup of the PROMISE study participants to continue for a total of one year to gather feasibility data on the safety and accuracy of the 365-day Eversense sensor. In a release, Mukul Jain, PhD, COO at Senseonics said, “Extending this study is really a critical step in developing a 365-day product. Information gathered from this cohort will allow us to characterize the improved sensor design and optimize our glucose algorithm for the extended, 365-day use period. This addition is an exciting extension phase of the PROMISE study and we look forward to evaluating the first multi-clinic investigation of a one-year implantable glucose sensor.” The overall goal of the PROMISE Clinical Study is to evaluate the safety and efficacy of the Eversense CGM System in people with diabetes over 180 days for the PMA submission to FDA. One hundred and eighty-one study participants at eight sites across the U.S. had the Eversense CGM System inserted subcutaneously as part of the study, which is completing the 180-...
Source: MDDI - Category: Medical Devices Authors: Tags: Business Source Type: news