HealthInterlink, Omaha, Neb, has received 510(k) clearance from the FDA to market Beacon version 2.0, a scalable software-based remote patient monitoring solution.
According to the company, 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.
The system incorporates FDA-cleared, wireless, patient monitoring devices and a gateway device – a tablet or smart phone – to transmit physiological data, answer patient questions, and connect with Beacon Clinical Care Access for a review by healthcare providers.
“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 begin commercialization of the Beacon 2.0 in the United States immediately, and is continuing to develop other applications where the system can be utilized to enhance remote patient monitoring.
“Beacon shows our commitment to our customers’ needs and our desire to continually enhance and improve our remote patient monitoring software. We are always striving for better outcomes and value for patients and providers,” Kehm said.