Cyberliver Gets Breakthrough Device Designation for CirrhoCare

Cyberliver has received a Breakthrough Device designation from the FDA for its CirrhoCare device for out-of-hospital management of cirrhosis patients at risk of new acute complications of cirrhosis.

The system includes monitoring sensors, a mobile application which receives data from the sensors, a brain dysfunction monitoring app and a proprietary algorithm that combines the data with patient inputs.

The Breakthrough Device designation was supported by results from a clinical trial that showed the device reduced rehospitalization due to cirrhosis complications by 38 percent.

The designation will enable the company to interact with the FDA to expedite the agency’s regulatory review of its marketing submission.