China's Viatom gets FDA nod for vital sign monitor in its bid for the 'real medical Tricorder'
|Checkme Pro with mini-monitor--Courtesy of Viatom Technology|
In the latest regulatory victory for the mobile, monitored patient, the FDA has cleared the Checkme Pro Health Monitor from China-based Viatom Technology. The device can be used as a cabled or cable-free ECG, pulse oximeter, thermometer and a blood pressure monitor. It also includes a pedometer and sleep monitor for the more wellness-oriented health measures.
The Checkme Pro transmits all this data wirelessly via Bluetooth to mobile devices to store and analyze data. The CE-marked version includes a dedicated mini-monitor that resembles a tablet; it also has a cuffless blood pressure monitor option. It also works with desktop software that can manage, analyze and store data from multiple monitors.
The U.S. version retails for $479, while the EU version with mini-monitor is $569 and $489 without it. The device is expected to be used in a hospital setting, a physician's office or even at home for personal use and telemedicine. The company's site touts the Checkme Pro as the "real medical Tricorder."
The newly FDA-cleared Checkme Pro includes a two-lead ECG monitor and electrodes that enable it to offer data on heart rate, QRS duration, ST segment and rhythm analysis. It also includes a charging cable, a wristband for wearable tech functions and a charging adapter.
Viatom is hardly alone in the race for a hand-held device that monitors multiple vital functions. Scanadu is a notable competitor that got a $35 million investment last April in anticipation of an FDA submission for its Scout device that monitors vital signs including heart rate, blood pressure, blood oxygen level and temperature. The handheld is in an ongoing 6-month trial in more than 4,000 people run by the Scripps Translational Science Institute that's slated for the FDA.
Scanadu emerged largely via a successful Indiegogo crowdfunding campaign in addition to its entry into an Xprize competition sponsored by Qualcomm ($QCOM) to find a real-life Tricorder to accurately emulate its fictional Star Trek-inspired counterpart. The contest is slated to announce its winners early next year.
The first place winner stands to receive $7 million in financing, while second place takes home $2 million and third gets $1 million.
- here is the FDA clearance notification
MIT researchers develop ingestible real-time vital sign monitor
Intelesens gets FDA clearance for its Zensor wearable vital signs device
Scripps, Scanadu finalize 4K+ vital sign trial enrollment, FDA-ready data due in 2016
Startup wins $9.4M Series A to back speedy hand-held vital sign scanner
Scanadu ropes in $35M for smartphone tricorder diagnostic device
NHS, Oxford University in U.K. pilot study of camera-based patient monitoring
Xprize seeks Star Trek's tricorder in $10M mobile diagnostics competition
OrbiMed backs an Israeli startup developing a futuristic, hand-held diagnostic device