Click here to close now.




















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
It’s been proven time and time again that in tech, diversity drives greater innovation, better team productivity and greater profits and market share. So what can we do in our DevOps teams to embrace diversity and help transform the culture of development and operations into a true “DevOps” team? In her session at DevOps Summit, Stefana Muller, Director, Product Management – Continuous Delivery at CA Technologies, answered that question citing examples, showing how to create opportunities for ...
Puppet Labs has announced the next major update to its flagship product: Puppet Enterprise 2015.2. This release includes new features providing DevOps teams with clarity, simplicity and additional management capabilities, including an all-new user interface, an interactive graph for visualizing infrastructure code, a new unified agent and broader infrastructure support.
SYS-CON Events announced today that Pythian, a global IT services company specializing in helping companies leverage disruptive technologies to optimize revenue-generating systems, has been named “Bronze Sponsor” of SYS-CON's 17th Cloud Expo, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. Founded in 1997, Pythian is a global IT services company that helps companies compete by adopting disruptive technologies such as cloud, Big Data, advance...
Skeuomorphism usually means retaining existing design cues in something new that doesn’t actually need them. However, the concept of skeuomorphism can be thought of as relating more broadly to applying existing patterns to new technologies that, in fact, cry out for new approaches. In his session at DevOps Summit, Gordon Haff, Senior Cloud Strategy Marketing and Evangelism Manager at Red Hat, discussed why containers should be paired with new architectural practices such as microservices rathe...
IBM’s Blue Box Cloud, powered by OpenStack, is now available in any of IBM’s globally integrated cloud data centers running SoftLayer infrastructure. Less than 90 days after its acquisition of Blue Box, IBM has integrated its Blue Box Cloud Dedicated private-cloud-as-a-service into its broader portfolio of OpenStack® based solutions. The announcement, made today at the OpenStack Silicon Valley event, further highlights IBM’s continued support to deliver OpenStack solutions across all cloud depl...
ElasticBox, the agile application delivery manager, announced freely available public boxes for the DevOps community. ElasticBox works with enterprises to help them deploy any application to any cloud. Public boxes are curated reference boxes that represent some of the most popular applications and tools for orchestrating deployments at scale. Boxes are an adaptive way to represent reusable infrastructure as components of code. Boxes contain scripts, variables, and metadata to automate proces...
Puppet Labs is pleased to share the findings from our 2015 State of DevOps Survey. We have deepened our understanding of how DevOps enables IT performance and organizational performance, based on responses from more than 20,000 technical professionals we’ve surveyed over the past four years. The 2015 State of DevOps Report reveals high-performing IT organizations deploy 30x more frequently with 200x shorter lead times. They have 60x fewer failures and recover 168x faster
To support developers and operations professionals in their push to implement DevOps principles for their infrastructure environments, ProfitBricks, a provider of cloud infrastructure, is adding support for DevOps tools Ansible and Chef. Ansible is a platform for configuring and managing data center infrastructure that combines multi-node software deployment, ad hoc task execution, and configuration management, and is used by DevOps professionals as they use its playbooks functionality to autom...
SYS-CON Events announced today that IceWarp will exhibit at the 17th International Cloud Expo®, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. IceWarp, the leader of cloud and on-premise messaging, delivers secured email, chat, documents, conferencing and collaboration to today's mobile workforce, all in one unified interface
Containers are not new, but renewed commitments to performance, flexibility, and agility have propelled them to the top of the agenda today. By working without the need for virtualization and its overhead, containers are seen as the perfect way to deploy apps and services across multiple clouds. Containers can handle anything from file types to operating systems and services, including microservices. What are microservices? Unlike what the name implies, microservices are not necessarily small,...
All major researchers estimate there will be tens of billions devices - computers, smartphones, tablets, and sensors - connected to the Internet by 2020. This number will continue to grow at a rapid pace for the next several decades. With major technology companies and startups seriously embracing IoT strategies, now is the perfect time to attend @ThingsExpo, November 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. Learn what is going on, contribute to the discussions, and e...
This Enterprise Strategy Group lab validation report of the NEC Express5800/R320 server with Intel® Xeon® processor presents the benefits of 99.999% uptime NEC fault-tolerant servers that lower overall virtualized server total cost of ownership. This report also includes survey data on the significant costs associated with system outages impacting enterprise and web applications. Click Here to Download Report Now!
SYS-CON Events announced today that G2G3 will exhibit at SYS-CON's @DevOpsSummit Silicon Valley, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. Based on a collective appreciation for user experience, design, and technology, G2G3 is uniquely qualified and motivated to redefine how organizations and people engage in an increasingly digital world.
Too often with compelling new technologies market participants become overly enamored with that attractiveness of the technology and neglect underlying business drivers. This tendency, what some call the “newest shiny object syndrome,” is understandable given that virtually all of us are heavily engaged in technology. But it is also mistaken. Without concrete business cases driving its deployment, IoT, like many other technologies before it, will fade into obscurity.
Whether you like it or not, DevOps is on track for a remarkable alliance with security. The SEC didn’t approve the merger. And your boss hasn’t heard anything about it. Yet, this unruly triumvirate will soon dominate and deliver DevSecOps faster, cheaper, better, and on an unprecedented scale. In his session at DevOps Summit, Frank Bunger, VP of Customer Success at ScriptRock, will discuss how this cathartic moment will propel the DevOps movement from such stuff as dreams are made on to a prac...