Healthcare Business News

Home-based monitor for patient data gets FDA clearance

By Joseph Conn
Posted: January 14, 2014 - 3:00 pm ET

A touch screen wireless home device that serves as a hub for receipt and transmission of patient-generated healthcare data has received market clearance from the Food and Drug Administration.

Alere HomeLink, a tablet-sized device, can receive data from a patient's digital or wireless weight scales, pulse oximeters, blood pressure cuffs and blood glucose monitors, either via a wire with a USB direct connection, or wirelessly from devices equipped with either the Bluetooth or Low-Energy Bluetooth communications capabilities.

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With the advent of accountable care organizations and the proposed shift to performance-based healthcare payments, patient-generated clinical data from home-based monitors and wearable devices are expected to play a key role in lowering the cost and improving the quality of care to patients with chronic diseases, whose care is estimated to consume 75% of U.S. healthcare expenditures, according to industry experts.

The touch screen also enables patients to answer questions posed to them by home health and disease managers, such as, “Did you eat today?” or “Did you take your meds today?”

The device, made by Waltham, Mass.-based and publicly traded diagnostics products maker and home health support provider Alere Corp., is part of the Alere Connect family of remote health monitoring products. The Alere Connect unit was created when the company acquired MedApps, when Alere purchased the then 6-year-old MedApps in 2012 for a reported $22 million.

Alere received 510 (k) market clearance from the FDA indicating it is equivalent to other FDA-approved devices. The clearance is for marketing by prescription and for sales over the counter without a prescription.

Alere Connect CEO Kent Dicks said Alere's new hub and a few basic wireless home devices—a scale as well as pulse ox, BP and glucose monitoring devices—can now be purchased for about $1,000, down from $3,000 to $4,000 a few years ago.

Follow Joseph Conn on Twitter: @MHJConn

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