Alere Connect gets FDA 510(k) clearance for home health hub

By Jonah Comstock
05:02 am
The Alere INRatio2 PT/INR Monitor, which will connect to MobileLink. The Alere INRatio2 PT/INR Monitor, which will connect to MobileLink.

Alere Connect, the Alere subsidiary formerly known as MedApps, received FDA 510(k) clearance for its MobileLink system. The system is a cloud-based communication hub that connects a single remote monitoring device to its Connected Health platform, allowing data to pass between patients, providers and electronic health records (EHRs).

The initial use case for MobileLink will be prescription, involving Alere's INRatio2 PT/INR Monitor. This is a monitor for patients taking anticoagulate medications, to make sure they don't take too little or too much, which can lead to dangerous outcomes. However, MobileLink is also cleared for over-the-counter monitoring devices such as blood pressure monitors, glucose sensors, and weight scales.

Kent Dicks, CEO of Alere Connect, said MobileLink uses M2M cellular to connect a single device to Alere's hub, even if the home of the user doesn't have WiFi. It's the first in a series of home monitoring hubs the company will be releasing. The next, an update of MedApp's HealthPAL, which will have a new name, will connect multiple remote monitoring devices to the hub wirelessly, for patients with multiple comorbid conditions. The third product, called HomeLink, will be a similar offering but with a touch screen for patients who want more interaction with their health. It will ask patients questions about whether they've checked their vitals or taken medication today.

Learn on-demand, earn credit, find products and solutions. Get Started >>

Dicks said MobileLink will be released around mid-September. The product will be sold B2B to hospitals, home health care agencies, ACOs, and payer programs.

Alere acquired remote monitoring startup MedApps just over a year ago. Since then the company has been rather quiet, give or take a rumor about future acquisitions. Dicks said the company has been busy developing MobileLink, and integrating Alere's existing systems with MedApps' products.

With the acquisition, Dicks said Alere is in a unique position because of the diversity of its offerings, which include the Alere Accountable Care Solutions, another Alere acquisition. Then known as Wellogic, it was acquired in 2011. Alere Accountable Care Solutions is handling the analysis and integration of MobileLink device data into EHRs.

"Our differentiating value is we have the ability to offer a variety of services around our product, from the health information exchanges, to data analytics, to informatics, to a disease management perspective," said Dicks. "Nobody else that offers that full of a solution."

MobileLink also secured CE Mark certification, allowing it to come to European markets later this year.


The latest news in digital health delivered daily to your inbox.

Thank you for subscribing!
Error! Something went wrong!