Welcome!

News Feed Item

Alere HomeLink Receives FDA Clearance for Over-the-Counter Use

New Cellular Connectivity Hub Connects Remote Patients, Providers and Other Alere Products to Connected Health Platform

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 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."

About Alere 
By developing new capabilities in near-patient diagnosis, monitoring and health management, Alere enables individuals to take charge of improving their health and quality of life at home. Alere's global leading products and services, as well as its new product development efforts, focus on cardiology, women's health, infectious disease, oncology and toxicology. Alere is headquartered in Waltham, Massachusetts. For more information regarding Alere please visit www.alere.com.

About Alere Connect 
Since 2006 Alere Connect (formerly MedApps®) has developed remote health monitoring solutions that efficiently connect patients with their care providers and electronic health records. Alere Connect is a UL certified company whose regulatory achievements include ISO 13485 / ISO 9001: 2008 certification, CE Mark certification, Health Canada License and multiple FDA clearances. As an acknowledged innovator in the field of remote health monitoring, the company was most recently recognized with a 2011 Edison Award in the product category of Health, Wellness & Safety. For more information, please visit www.alereconnect.com.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the federal securities laws, including statements regarding the product's ability to improve health outcomes and reduce costs. These statements reflect Alere's current views with respect to future events and are based on their current assumptions and information currently available.  Actual results may differ materially due to numerous factors including, without limitation, acceptance of the technology and Alere Health health management programs which utilize the technology by patients and customers of Alere Health, as well as, the other risks described in the "Risk Factors" section of Alere's Annual Report on Form 10-K filed with the SEC on March 1, 2013, as amended. Alere undertakes no obligation to update any forward-looking statements contained herein.

SOURCE Alere

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
Today we can collect lots and lots of performance data. We build beautiful dashboards and even have fancy query languages to access and transform the data. Still performance data is a secret language only a couple of people understand. The more business becomes digital the more stakeholders are interested in this data including how it relates to business. Some of these people have never used a monitoring tool before. They have a question on their mind like “How is my application doing” but no id...
Actian Corporation has announced the latest version of the Actian Vector in Hadoop (VectorH) database, generally available at the end of July. VectorH is based on the same query engine that powers Actian Vector, which recently doubled the TPC-H benchmark record for non-clustered systems at the 3000GB scale factor (see tpc.org/3323). The ability to easily ingest information from different data sources and rapidly develop queries to make better business decisions is becoming increasingly importan...
The 19th International Cloud Expo has announced that its Call for Papers is open. Cloud Expo, to be held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, brings together Cloud Computing, Big Data, Internet of Things, DevOps, Digital Transformation, Microservices and WebRTC to one location. With cloud computing driving a higher percentage of enterprise IT budgets every year, it becomes increasingly important to plant your flag in this fast-expanding business opportuni...
Qosmos has announced new milestones in the detection of encrypted traffic and in protocol signature coverage. Qosmos latest software can accurately classify traffic encrypted with SSL/TLS (e.g., Google, Facebook, WhatsApp), P2P traffic (e.g., BitTorrent, MuTorrent, Vuze), and Skype, while preserving the privacy of communication content. These new classification techniques mean that traffic optimization, policy enforcement, and user experience are largely unaffected by encryption. In respect wit...
Deploying applications in hybrid cloud environments is hard work. Your team spends most of the time maintaining your infrastructure, configuring dev/test and production environments, and deploying applications across environments – which can be both time consuming and error prone. But what if you could automate provisioning and deployment to deliver error free environments faster? What could you do with your free time?
SYS-CON Events announced today that Hitrons Solutions will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Hitrons Solutions Inc. is distributor in the North American market for unique products and services of small and medium-size businesses, including cloud services and solutions, SEO marketing platforms, and mobile applications.
Smart Cities are here to stay, but for their promise to be delivered, the data they produce must not be put in new siloes. In his session at @ThingsExpo, Mathias Herberts, Co-founder and CTO of Cityzen Data, will deep dive into best practices that will ensure a successful smart city journey.
SYS-CON Events announced today that 910Telecom will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Housed in the classic Denver Gas & Electric Building, 910 15th St., 910Telecom is a carrier-neutral telecom hotel located in the heart of Denver. Adjacent to CenturyLink, AT&T, and Denver Main, 910Telecom offers connectivity to all major carriers, Internet service providers, Internet backbones and ...
SYS-CON Events announced today that eCube Systems, a leading provider of middleware modernization, integration, and management solutions, will exhibit at @DevOpsSummit at 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. eCube Systems offers a family of middleware evolution products and services that maximize return on technology investment by leveraging existing technical equity to meet evolving business needs. ...
DevOps at Cloud Expo – being held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA – announces that its Call for Papers is open. Born out of proven success in agile development, cloud computing, and process automation, DevOps is a macro trend you cannot afford to miss. From showcase success stories from early adopters and web-scale businesses, DevOps is expanding to organizations of all sizes, including the world's largest enterprises – and delivering real results. Am...
Pulzze Systems was happy to participate in such a premier event and thankful to be receiving the winning investment and global network support from G-Startup Worldwide. It is an exciting time for Pulzze to showcase the effectiveness of innovative technologies and enable them to make the world smarter and better. The reputable contest is held to identify promising startups around the globe that are assured to change the world through their innovative products and disruptive technologies. There w...
Internet of @ThingsExpo, taking place November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with 19th Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. The Internet of Things (IoT) is the most profound change in personal and enterprise IT since the creation of the Worldwide Web more than 20 years ago. All major researchers estimate there will be tens of billions devices - comp...
DevOps at Cloud Expo, taking place Nov 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with 19th Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. The widespread success of cloud computing is driving the DevOps revolution in enterprise IT. Now as never before, development teams must communicate and collaborate in a dynamic, 24/7/365 environment. There is no time to wait for long dev...
SYS-CON Events announced today that StarNet Communications will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. StarNet Communications’ FastX is the industry first cloud-based remote X Windows emulator. Using standard Web browsers (FireFox, Chrome, Safari, etc.) users from around the world gain highly secure access to applications and data hosted on Linux-based servers in a central data center. ...
Traditional on-premises data centers have long been the domain of modern data platforms like Apache Hadoop, meaning companies who build their business on public cloud were challenged to run Big Data processing and analytics at scale. But recent advancements in Hadoop performance, security, and most importantly cloud-native integrations, are giving organizations the ability to truly gain value from all their data. In his session at 19th Cloud Expo, David Tishgart, Director of Product Marketing ...