Alere Connect has been granted a 510(k) market clearance by the U.S. Food and Drug Administration (FDA) for Alere HomeLink. The product has also received CE Mark certification, which allows it to be marketed within Europe as well as in the US.
This new product offering is part of a series of the company’s connected device technologies, which are designed to empower patients to self-test at home and deliver data quickly and seamlessly to clinical systems accessed by their healthcare providers. The Alere MobileLink recently received FDA-clearance in July 2013.
Alere HomeLink provides a gateway to Alere’s Connected Health platform, with integrated products and services for health management. These tools efficiently connect the patient to their provider and enhance care by putting actionable health information at physicians’ fingertips.
Alere HomeLink 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 (COPD), 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.
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 lower cost Alere MobileLink provides one USB connection).
The Alere HomeLink has a 7-inch touch screen display that allows patients to submit responses to disease management questions along with their test measurements. Both devices’ core function is automated data transmission to the Cloud.
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.
The collected data becomes more meaningful by leveraging the evidence-based medical content provided by the Alere Clinical Decision Support Platform.
Alere Connect CEO Kent Dicks noted, "Alere HomeLink is the latest and most advanced of our connected device technologies, and enhances the provider-patient relationship by empowering patients to manage their health more successfully in their homes and making critical health information easily available to their providers through our Alere CloudCare Platform."
Craig Keyes, MD, CEO of Alere Health, added, "Alere Health believes strongly in the value of incorporating biometric devices in our health management programs. 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."