Viatom gets FDA clearance for Checkme vitals monitoring device

By Aditi Pai
01:24 pm

China-based Viatom Technologies has received FDA 510(k) clearance for Checkme Pro, a connected medical device that tracks a number of vital signs, according to Medgadget.

The small Checkme Pro device includes an ECG that tracks heart rate, QRS duration, ST segment, and rhythm analysis, a pulse oximeter, an activity tracker, a thermometer, and a sleep monitor. The device can be set to a hospital mode or a home mode. In the home mode, patients can do a daily check using the device to log specific data points regularly, like ECG and SpO2. 

Data from the device is sent to a companion app and from there to the physician, who can view the information in the Checkme data management program. The data management offering, available on desktops and tablets, allows doctors to review, print, and archive patient data.

Checkme Pro costs $479. Viatom also offers other versions of its Checkme device.  Prior to the FDA clearance, Viatom launched a CE-marked Checkme Pro, which costs $489. It wasn't released in the US. Other Viatom products include Z3, a wristworn SpO2 monitoring device, and OxiCheck, a handheld oximeter.

A few months ago, Belfast, Northern Ireland-based Intelesens received FDA 510(k) clearance for its wearable vital signs monitor, called zensor, designed for monitoring patients outside the hospital. Zensor is a small, battery-powered device that clips on to an adhesive patch which also contains electrodes. The device can be worn for seven days at a time and collects data on respiration rate, three-lead ECG, heart rate, and motion.

And in May a few other companies working on devices that track vital signs got FDA clearances including toSense's CoVa monitoring system, InvisionHeart's ECG Device, and Vitaphone's Post-Event Recorder.

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