Senseonics submits FDA PMA application for Eversense CGM

Senseonics (NYSE:SENS) said today it submitted a premarket approval application to the FDA for its Eversense continuous glucose monitoring system.

The Eversense system includes an implanted glucose sensor designed to last up to 90 days, as well as a wearable smart transmitter designed to calculate glucose levels. The devices work in tandem with a mobile application that allows for the real-time display of glucose readings, the company said.

“The submission of our PMA marks a significant milestone toward meeting our goal of bringing an accurate, reliable and long-lasting CGM system to people with diabetes in the United States. We look forward to working with the FDA to receive approval as quickly as possible,” prez & CEO Tim Goodnow said in a press release.

The application will be supported by data from a 90-patient pivotal trial of the device, which followed adults with Type 1 or Type 2 diabetes over 90 days of CGM sensor wearing, the company said. Results from the trial are slated to be presented at the Diabetes Technology Meeting in Bethesda, Md. on November 10.

The Germantown, Md.-based company said that, upon receiving FDA approval, it will initiate sales within the U.S.

Senseonics won CE Mark approval in the European Union in May. The device is indicated for continually measuring interstitial fluid glucose levels in adults as an adjunctive device to complement information obtained from standard home blood glucose meters.

The company said plans to conduct post-market surveillance, including long-term safety and performance data now that the device has been cleared in the EU.

The post Senseonics submits FDA PMA application for Eversense CGM appeared first on MassDevice.

from MassDevice http://ift.tt/2eZoDJ1