Withings recently launched an FDA cleared non-invasive infrared temporal thermometer that syncs temperature readings with WiFi or Bluetooth and syncs with your iPhone or Android device. Unfortunately, Withings Thermo device being “FDA cleared” is somehow being understood as the device being accurate — it’s a sentiment I read often when reporting was done on the device. It’s important to remember the difference between FDA cleared versus FDA approved. We have written extensively about FDA approval on iMedicalApps before.
FDA cleared medical devices are those the FDA considers substantially equivalent to another legally marked device. In this case — there are several other temporal thermometers available on the market. All that is required is that a premarket notification, 501(k), be submitted by the manufacturer, in this case Withings and Nokia. Actual FDA approval is required for high-risk medical devices and gets a more in-depth premarket review.
As several studies have shown, temporal thermometers are not accurate, and unless Withings has data to prove otherwise, you’re going to get a significantly more accurate temperature using a traditional oral or rectal thermometer. The systematic review and meta-analysis by Geijer and colleagues published in BMJ that reviewed the accuracy of temporal thermometers found significant variance in temperatures using these devices — plus or minus 1 degree Celsius in some cases. That’s the difference between 98.6 and 100.4 degrees Fahrenheit — clinically very significant for physicians (think SIRS criteria). The systematic review did find some utility of these noninvasive devices, such as reports of less stress and possibly less psychologic harm when children didn’t have to get oral or rectal temperature checks. The other “good news” in the study was temporal thermometers are just as inaccurate as tympanic thermometers.
I personally don’t recommend the use of tympanic thermometers or temporal thermometers to patients, especially in the pediatric patient population when dosing of antipyretics is determined by a child’s temperature.
That said, I’m still very excited about Nokia’s acquisition of Withings and we’re fans of the products that Withings has made in the digital health space, such as their wireless blood pressure monitor. I’m excited to see what Withings will produce next.