FDA Clears Alere Connect’s HomeLink Hub

Alere Connect has received U.S. Food and Drug Administration (FDA) clearance for its latest home health hub, HomeLink. The clearance rounds out Alere Connect’s portfolio of hub devices to three main options: HomeLink, MobileLink, and HealthPAL. While each of the hub devices uses a cellular radio for backhaul — no need to connect it through the ethernet or home WiFi — personal health devices connect to them in various ways.

The most recently cleared device, HomeLink, connects to blood pressure monitors, pulse oximeters, glucose meters, and weight scales via USB, Bluetooth, or BLE. Alere Connect CEO Kent Dicks told MobiHealthNews that the device also has a FitLinxx receiver in it, which points to future plans to integrate wellness devices, like smart pedometers. Apart from the ability to connect to personal health devices wirelessly, HomeLink is distinct from MobileLink because it is able to receive data from multiple devices at once and because it features a 7-inch capacitive, touchscreen that enables care providers to ask survey patients right on the device.

MobileLink, which received FDA clearance last summer, is simpler by design, and only can connect to one device at a time through USB. The initial use case for MobileLink was for patients monitoring their anticoagulate medicine through Alere’s INRatio2 PT/INR Monitor. Like HomeLink, MobileLink also is approved for over-the-counter monitoring devices such as blood pressure monitors, glucose sensors, and weight scales.

Prior to the MedApps acquisition, Alere historically has used Tunstall hub devices. Dicks said there currently are between 30,000 and 40,000 of those devices in the United States and in some parts of Europe and Asia. Now that Alere has its own portfolio of hub devices, it will begin replacing the Tunstall hubs with HomeLink devices. 

Similar to MedApps, Dicks said that Alere Connect currently is focused on the 15 percent of the patient population that comprises 80 percent of US healthcare costs. Dicks said these hub devices are designed for use by that patient population, but Alere Connect “will be moving aggressively this year into smartphones, tablets, and probably smart TVs and kiosks as well.”

“The biggest mistake we’ve seen with other traditional companies that are out there is to go right to the patient — and just exclude the physician from the equation — and try to get the patient compliant on their own,” Dicks said. “With building the HIE, the analytics, and the programs that go around it, we want to be able to engage the physician too, and give them the right amount of information to engage their patients. Physicians get a lot of data already and they can’t be monitoring their patients all the time, so you need this hybrid call center approach in addition to other technology to keep the patient engaged between care visits along the way.”