Diabetes-focused device developer NeMaura Medical said today it won CE Mark approval in the European Union for its sugarBEAT minimally invasive wireless continuous glucose monitor.
The sugarBEAT CGM system is designed as a wearable sensor patch which transmits data via bluetooth to provide real time glucose readings on a standalone reader, smart watch or smart phone app, the U.K.-based company said.
The sugarBEAT system allows the user to decide when to wear the patch sensor, and does not require that the user wear the patch permanently, NeMaura said. The company said that the requirement to keep a CGM device on the body for up to 14 days is a “key reason” people have cited for not using current generation devices.
Approval came based on data from a 160 patient day study, and the company said it is in the process of completing a 2nd pre-submission to the FDA to “discuss their clinical strategy for the U.S. PMA route.”
NauMaura said it expects to begin U.S. studies by mid 2016, with a European launch expected by the end of 2016, according to a press release.