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 at FDA delayed the potential approval, but the Germantown, MD-based company says a decision is now expected in the coming weeks.
In a business 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 PMA supplement application is being supported by data from the PROMISE study. The submission was assigned to a lead 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 managing the backlog of COVID-19 related filings creating longer than expected review timelines. We are confident a decision regarding approval of the 180-day system will be made in the coming weeks as the FDA continues to clear out the backlog,” said Tim Goodnow, PhD, president and CEO of Senseonics.
Goodnow also said that in 2021 Senseonics integrated operations and coordination activities with its commercial collaborator, Ascensia Diabetes Care, and that a "thoughtful go-to-market strategy" is being designed to target a smooth transition to the 180-day system while providing uninterrupted service for patients, providers, and payers.
"We are excited to advance long-term solutions for people with diabetes as we continue to aim to make the new 180-day system available in the U.S.,” he said.
Senseonics also reiterated its financial outlook expectation for full year 2021 global net revenue to be in the middle of the company's gudiance range of $12 million to $15 million.