Alere Connect HomeLink Platform Gets FDA Approval
Alere Connect, formerly known as MedApps, has been granted a 510(k) market clearance by the U.S. Food and Drug Administration (FDA) for HomeLink, which provides a gateway to Alere's Connected Health platform, with integrated products and services for health management.
The 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 to clinical systems accessed by their health care providers. The company’s MobileLink product recently received FDA clearance in July 2013.
"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," Ken Dicks, CEO of Alere Connect, said in a statement.
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 device features 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.
"Alere Health believes strongly in the value of incorporating biometric devices in our health management programs," Craig Keyes, CEO of Alere Health, said in a statement. "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."
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, at home. All of Alere Connect's cellular communication hubs use the company’s proprietary CloudCare platform to connect medical devices in the field to clinical backend systems.
In addition, the platform is designed to facilitate 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 company’s Clinical Decision Support Platform.