NeMaura meets with FDA, plans for regulatory submission

Diabetes-focused device developer NeMaura Medical said today it met with the FDA to discuss the clinical programs necessary for pursuing premarket approval submission for its sugarBEAT minimally invasive wireless continuous glucose monitor.

The U.K.-based company said that as a result of the meeting it “determined a clear direction for the clinical program” and has picked Navigant to develop an investigational device exemption application for the device prior to launching a clinical program.

NeMaura hopes to submit its PMA application around mid 2017, according to a press release.

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 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.

In March, NeMaura Medical said it won CE Mark approval in the European Union for its sugarBEAT CGM.

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.”

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