Alere™ MobileLink Receives FDA Clearance
Alere™ Connect (an Alere Company) has been granted a 510(k) market clearance by the U.S. Food and Drug Administration for the Alere™ MobileLink. The new product offering is one of Alere's connected device technologies designed to empower patients by allowing self-testing at home and delivering data quickly and seamlessly to clinical systems accessed by their healthcare providers.
Alere™ MobileLink provides a gateway to Alere's Connected Health platform, which offers integrated tools and services that can enhance care and improve outcomes for all patients, whether they are participants in health and wellness or chronic disease management programs.
Initially, the Alere™ MobileLink will be rolled out with the Alere INRatio®2 PT/INR Monitor through Alere™ Home Monitoring, Inc. (AHM) in programs for patients using anticoagulant medications to monitor their INR levels at home. Available exclusively from AHM, this combination of Alere products and services is especially exciting as it will further differentiate the industry leading Alere programs for anticoagulation management. The Alere™ MobileLink is also FDA-cleared for over-the-counter use with other FDA-cleared devices including blood-pressure monitors, glucose meters and weight scale.
Alere™ MobileLink is the first of Alere™ Connect's cloud-based communication hubs designed to facilitate the seamless flow of actionable, comprehensive diagnostic data across patient, care professionals and electronic medical records. The Alere™ MobileLink recently received CE Mark certification, which will allow the product to be marketed in Europe as well as the US later this year.
Alere™ Connect CEO Kent Dicks, "Our remote monitoring solutions have been validated over the years with innovative healthcare organizations throughout the US. Our devices are being used to supply patient data directly into the provider's electronic health records system – integration is key. The Alere Connected Health platform has the ability to connect flexibly with devices and systems regardless of their manufacturer and origin. The platform captures and analyzes data with robust analytics, and then backs it up with comprehensive health management services. This is what is really exciting and distinguishes Alere as one of the few healthcare companies to offer a true, fully integrated solution that can impact patients' lives for the better."