Withings, the French connected device maker recently acquired by Nokia Technologies, has received FDA 510(k) clearance for Withings Thermo, the company's WiFi-enabled thermometer, MobiHealthNews has learned. The device was first announced in January at CES in Las Vegas.
Rather than being inserted in the mouth or armpit, Thermo measures temperature from the temporal artery on the user's forehead. The user simply holds the thermometer next to their head or a child’s head and an array of 16 independent infrared sensors measure the heat being emitted. Readings appear on the side of the device but are also automatically sent to a companion smartphone app, where users can assign them to a particular user and add any other notes.
“With just a point in the direction of the artery, without requiring any motion or scanning, the sensors take 4,000 measurements in two seconds while a specially-designed algorithm automatically corrects for biases, such as skin heat loss and the ambient temperature,” the company explained in a statement earlier this year. “The hottest point is then determined to ensure the most accurate and reliable single temperature reading.”
FDA documents show that Withings submitted the clearance document February 26th, well before their May acquisition by Nokia. The clearance was granted June 16th. Withings had originally planned to make Thermo available in the first quarter of this year, though CES launch dates are somewhat hit or miss, particularly when FDA clearance is a factor.
Most of Withings' devices, save their activity trackers, have FDA clearance. This was a factor in Nokia Technologies' decision to acquire the company, especially now that Nokia has set its sights on the regulated clinical device market. Last week, Nokia Technologies announced that it would work with Helsinki University Hospital (HUS) and the University of Helsinki to develop new technologies for outpatient care, starting with remote patient monitoring solutions.