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.

The platform provides a tablet with Internet connectivity and a user-friendly interface that allows each patient to communicate remotely with clinicians.

The Beacon CCA software application helps clinicians prioritize patient care, allows for early intervention and facilitates communication with patients in their home.

In one instance, the tablet comes with a kit in which the Kansas City Veteran Affairs (VA) branch has the option of including wireless, Bluetooth-enabled devices for measuring patient vitals—including blood pressure, oxygen saturation, heart rate, weight, temperature, blood glucose and peak flow, a recent case study detailed.

Each component leverages a Bluetooth-enabled connection to automatically upload results to the tablet. Patients can also choose to enter information manually—whether the data comes from a kit device or from a device provided by the patient.

To enable patients and clinicians to interact in real time, Presidio, a provider of professional and managed services for advanced IT solutions, can enhance the platform with optional instant-messaging text and video telehealth capabilities as well as voice over IP (VOIP) phone services powered by Cisco technologies.

Presidio also provides IT architecture expertise to ensure back-office servers at the VA hospital effectively and securely process patient-clinician interactions and integrate the system data with VistA, the VA's electronic medical records system.