Alere Connect has received FDA approval to market its home monitoring platform over the counter, the company's latest foray into the consumer-facing market.
The Alere HomeLink cellular connectivity hub has been granted 510(k) market clearance from the FDA, as well as receiving CE Mark certification, allowing it to be sold in the United States and Europe. HomeLink integrates with Alere's MobileLink platform, which received FDA clearance in July, and builds on a connected health platform that the company has been developing since 2006.
Officials at the Waltham, Mass.-based company, formerly known as MedApps, see the HomeLink hub as a gateway to home health management. To that end, HomeLink will be deployed in health management programs administered by Alere Health for patients managing chronic conditions, including diabetes, heart failure, hypertension and chronic pulmonary obstructive disease (COPD). HomeLink has been certified by the FDA to synch with devices such as glucose meters, weight scales, blood-pressure monitors and pulse oximeters.
With the shift to a patient-centered model of healthcare, companies like Alere have to find home monitoring solutions that will appeal not only to physicians and health plans, but also to the consumers themselves, all of whom have a financial stake in the process.
Kent Dicks, Alere Connect's CEO, said the solution gives the fragmented home health management market something to rally around.
There are "many disparate solutions that solve single issues and not a comprehensive all-encompassing solution for patient care," he said. "Patients/consumers are not properly incented to use the health monitoring tools in order to manage their health and achieve better outcomes. In order to achieve effective results from the mHealth market, it must consolidate to a comprehensive solution that provides a total care solution for a patient/consumer."
Dicks said such a solution should encapsulate health management, wellness, point-of-care diagnostics, health information exchange, analytics and remote patient monitoring.
"A comprehensive view of the patient from the Health Information Exchange (HIE) allows for the seamless flow of data from all connected devices, including point-of-care diagnostics and remote monitoring at home," he said. "Once data is presented into the HIE it is run through extensive sets of rules with the analytics which allow for prioritization of patients with given populations to determine which need changes in their given therapy in order to stay out of the hospital and have better outcomes. The combination of point-of-care, remote home monitoring, the HIE and analytics allows for a seamless flow of data in real time throughout the system to provide a prioritization of work load to affect the best outcomes."
The HomeLink consists of a 7-inch touchscreen display that allows consumers to submit test measurements and respond to disease management questions. HomeLink connects to compatible wireless devices via Bluetooth and Low-Energy Bluetooth, or USB. The data is sent to Alere's CloudCare Platform and integrates with the company's Health Information Exchange solution and Clinical Decision Support Platform, which offers evidence-based medical content.
