Alere Connect, Scottsdale, Ariz, has been granted a 510(k) market clearance by the US Food and Drug Administration (FDA) for the Alere HomeLink system, which provides a gateway to Alere’s Connected Health platform of integrated products and services for health management. These tools efficiently connect patients and providers by putting actionable health information at the physician’s fingertips.
The HomeLink system joins Alere’s current series of connected device technologies that are designed to empower patients to self-test at home and deliver data quickly and seamlessly to clinical systems accessed by their healthcare providers.
According to Alere, the HomeLink system will be deployed in health management programs administered by Alere Health for patients managing chronic conditions, such as diabetes, hypertension, heart failure, and chronic obstructive pulmonary disease at home.
The Alere HomeLink is also FDA-cleared for over-the-counter use with glucose meters, blood-pressure monitors, weight scales, and pulse oximeters. What’s more, the product has also received CE Mark certification, which allows it to be marketed within Europe as well as in the United States.
The Alere HomeLink can connect to multiple compatible monitoring devices with Bluetooth and Low-Energy Bluetooth for wireless integration. It can also use a wired USB connection to integrate devices with no radio protocol. The device features a 7-inch touch screen display that allows patients to submit responses to disease management questions along with their test measurements.
All of Alere Connect’s cellular communication hubs use the proprietary Alere CloudCare Platform to connect medical devices in the field to clinical backend systems. The platform facilitates a seamless flow of diagnostic data to Alere’s Health Information Exchange solution for integration across the continuum of care. According to Alere, the collected data becomes more meaningful by leveraging the evidence-based medical content provided by the company’s Clinical Decision Support Platform.
“Alere Health believes strongly in the value of incorporating biometric devices in our health management programs,” said Craig Keyes, MD and CEO of Alere Health. “By arming providers and patients with a more integrated tool that is linked to and controlled from the Cloud, Alere HomeLink brings seamless connectivity to the traditional healthcare delivery approach – potentially resulting in better health outcomes and significant cost savings.”