Portland, Ore.-based TZ Medical and German-based Cinterion say their new product, Aera-CT, has solved two key problems with at-home, wireless arrhythmia tracking--background noise and dual-module devices.
The Aera-CT is a single-unit device that TZ Medical Project Director Bob Doerr says simplifies the process for patients. The device has a cell phone embedded in it, so patients don't have to hook the monitoring device up to a cell phone, as they do with other products on the market.
"Often the target audience for this device has challenges--getting them to hook up the device to a cell phone or smartphone can be challenging," Manfred Kube, Cinterion's director for mHealth development, tells FierceMobileHealthcare. "This device requires no user interaction at all, and is as unobtrusive as it gets."
A custom set of leads and electrodes can filter out just about all the accompanying noises of daily life, which can be crucial when patients are recording their rhythms at home, Doerr tells FierceMobileHealthcare. "People are wearing this and...they're in their real life situations, such as in the gym, running outdoors, and a lot of other strenuous activities," he says. "It's remarkable how clear the ECG is today, and how readable in those settings."
The device continuously records patient heart rhythms, and can be set up to transmit the information at regular intervals to a central online database where clinicians can review the data, according to Doerr. Physicians also can communicate directly with the device to take an ad hoc reading or change recording or transmission parameters, such as which type of arrhythmias to track, or how frequently the device transmits its data.
The unit is set for initial rollout this fall, Doerr says, although that will depend in part upon the progress of its 510(k) application by the FDA. He says he's hoping to hear a decision within the next 30 days.
To learn more:
- check out the announcement
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