FDA has granted Alere™ Connect a 510 (k) market clearance for their “Alere MobileLink” and also cleared the device for over-the-counter use with other FDA cleared devices including blood pressure monitors, glucose meters and weight scales. The “Alere MobileLink” also recently received CE Mark certification to allow the product to be marketed in Europe and in the U.S later this year.
The new product offering is one of Alere’s connected device technologies that enables patients to do self-testing at home and deliver the data quickly and seamlessly to clinical systems to be accessed by their healthcare providers.
The “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 patients, care professions, and EMRs.
Initially, the “Alere MobileLink” will be rolled out with the INRatio®2PT/INR Monitor through Alere Home Monitoring Inc. The technology will be used in programs for patients using anticoagulant medications to monitor their INR levels at home.
Alere Connect CEO Kent Dicks, reports “Our remote monitoring solutions have been validated over the years with innovative healthcare organization throughout the U.S. Our devices are being used to supply patient data directly into the provider’s EHR system where integration is key. The Alere Connected Health platform is able to connect flexibly with devices and systems and captures and analyzes data with robust analytics, and then is able to back it up with comprehensive health management services.”
For more information, go to www.alere.com.