HomeLink Receives FDA Clearance

Alere HomeLink has been granted 510(k) market clearance by FDA for over the counter use for glucose meters, blood pressure monitors, weight scales, and pulse oximeters. In addition Alere HomeLink received CE Mark certification to market in Europe and received FDA clearance for Alere MobileLink July 2013.

Alere Connect’s HomeLink is part of the company’s connected device technologies and is going to be used in health management programs administered by Alere Health for patients to help manage chronic condition such as diabetes, hypertension, heart failure, and COPD at home.

The company’s 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.

HomeLink has a seven inch touch screen display that allows patients to submit responses to disease management questions along with their test measurement. The device’s core function automates 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 enables a seamless flow of diagnostic data to Alere’s Health Information Exchange solution for integration across the continuum of care.

Alere Connect CEO Kent Dicks notes, “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 home and makes critical health information available to their providers through the Alere CloudCare Platform.”

For more information email Jackie Lustig, Director, Corporate Communications at Jackie.lustig@alere.com or call 781-341-4009.

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