HealthInterlink®, a provider of remote patient monitoring software applications, announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market Beacon® version 2.0, a scalable software-based remote patient monitoring solution.
Beacon’s software incorporates FDA cleared, wireless patient monitoring devices and a gateway device, (such as a tablet or smart phone) which transmits physiological data, answers to questions, and messages to Beacon Clinical Care Access for review by healthcare providers. Beacon is a flexible and intuitive software application that helps clinicians prioritize patient care, allows for early intervention, and facilitates communication with patients in their home.
“We see this clearance as a major milestone in helping make chronic care more convenient and less disruptive for patients,” said Danna Kehm, managing director of HealthInterlink. “Regulatory clearance of our software shows that it performs equivalently to a traditional bulky monitor and helps us move towards our bigger vision of reimagining chronic care with mobile devices in a mHealth world.” HealthInterlink will roll out Beacon in the U.S. immediately and is developing other applications where the system can be used to enhance remote patient monitoring.