One of the 10 most anticipated new medical devices of 2021 was the next-generation Eversense 180-day continuous glucose monitoring (CGM) system from Senseonics. Unfortunately, COVID-related backlogs with the FDA have delayed possible approval, but the Germantown, MD-based company says a decision is now expected in the coming weeks.
In a corporate update, Senseonics said all questions raised by the agency during the review process have been answered. The company submitted the PMA supplement in October 2020. The application for the PMA supplement is supported by data from the PROMISE study. The submission was assigned to a leading FDA reviewer last April. If approved, the CGM system would be approved for 180 days of use, as opposed to the current 90-day indication.
“We understand that the FDA is at full capacity to manage the backlog of COVID-19-related filings, causing longer-than-expected review times. We are confident that a decision will be made in the coming weeks on the approval of the 180-day system as the FDA continues to clear the backlog,” said Tim Goodnow, PhD, president and CEO of Senseonics.
Goodnow also said Senseonics will integrate operations and coordination activities with its commercial associate, Ascensia Diabetes Care, in 2021 and that a “thought-out go-to-market strategy” is being designed to ensure a smooth transition to the 180-day system. while providing uninterrupted service to patients, providers and payers.
“We are excited to advance long-term solutions for people with diabetes as we continue to strive to make the new 180-day system available in the US,” he said.
Senseonics also reiterated its financial outlook that global net income for full year 2021 will be in the middle of the company’s advisory range of $12 million to $15 million.
With this pending FDA decision, the diabetes technology market is expected to see quite a bit of activity in 2022 as Dexcom, Insulet and Medtronic also have next-generation devices in the pipeline.