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Alere HomeLink Receives FDA Clearance for Over-the-Counter Use
Date:1/14/2014

WALTHAM, Mass., Jan. 14, 2014 /PRNewswire/ -- 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.

(Photo: http://photos.prnewswire.com/prnh/20140114/NE45143 )

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
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