HealthInterlink Gets FDA Nod for Remote Patient-Monitoring Offering
HealthInterlink received clearance from the FDA to market the Beacon Version 2.0 remote patient-monitoring offering.HealthInterlink, a provider of remote patient monitoring software applications, announced that 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. The company said it would immediately commence commercialization in the United States for the Beacon application and is continuing to develop other applications where the system can be used to enhance remote patient monitoring. "We see this clearance as a major milestone in helping make chronic care more convenient and less disruptive for patients," Danna Kehm, managing director of HealthInterlink, said in a statement. "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." 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 (Beacon CCA) for review by health care providers.
"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 stated.