Alere HomeLink Receives FDA Clearance for Over-the-Counter Use
WALTHAM, Mass., Jan. 14, 2014 - 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.
(Media-Newswire.com) - WALTHAM, Mass., Jan. 14, 2014 — 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.
HomeLink Home Screen_colorThis 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.”
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.
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.
This story was released on 2014-01-21. Please make sure to visit the official company or organization web site to learn more about the original release date. See our disclaimer for additional information.