Google’s latest flagship phone, the Pixel 8 Pro, boasts an intriguing feature that isn’t receiving much fanfare. Located on the back of the Pixel 8 Pro, a cutting-edge temperature sensor now empowers you to swiftly scan objects and determine their temperature. This versatile capability enables you to ascertain if your frying pan has reached the ideal temperature for cooking or if your baby’s bottle contains milk at the perfect temperature. Additionally, we’ve taken the initiative to submit an application to the FDA, paving the way for the Pixel’s Thermometer App to measure your body temperature and seamlessly integrate it into your Fitbit records.
Indeed, the world of temperature measurement can be a bit complex, particularly when it comes to medical data and regulatory clearance. In the case of Google’s Pixel 8 Pro and its temperature sensor, things take a nuanced turn. While an ordinary off-the-shelf infrared thermometer can efficiently determine the temperature of objects like a hot pan or a baby bottle, the moment it’s directed at a human being for the purpose of measuring body temperature, it enters the realm of medical data. This categorizes it as a Class II medical device, mandating clearance from the Food and Drug Administration (FDA).
Here’s where the intricacy lies: Google doesn’t necessarily require FDA clearance for the phone itself or even for the temperature sensor as a standalone component. Technically, there’s no obligation for FDA clearance as long as the temperature sensor is employed for a purpose other than explicitly measuring and displaying your body temperature. Several companies have already incorporated infrared temperature sensors into smartwatches for functions such as sleep tracking and cycle prediction, but they meticulously avoid presenting this data as body temperature to sidestep the FDA’s regulatory requirements.
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You might be tempted to try pointing the Pixel 8 Pro’s temperature sensor at your forehead and taking your temperature with it anyway. However, it’s essential to understand that doing so won’t provide your body temperature; it will merely give you the temperature of the surface of your forehead. These are not the same measurements. For example, a non-contact infrared thermometer might display a reading of 98.3 degrees Fahrenheit when used on your forehead for body temperature, but when switched to surface mode, it might show a much lower reading, say 94.7 F, for the same spot.
When it comes to securing FDA clearance (not approval) for Class II devices like the Pixel 8 Pro’s temperature sensor, there are a couple of routes to pursue. Google has not disclosed which path it’s taking or when it initiated the approval process. One avenue is de novo authorization, a route that Apple sought for the Apple Watch’s on-wrist EKG detection in the past. This pathway is reserved for devices that don’t have close analogs on the market and are deemed to be reasonably safe and effective.
While non-contact infrared thermometers themselves aren’t particularly groundbreaking, Google’s unique implementation and potential use cases could set its device apart. However, it’s plausible that Google has opted for 510(k) clearance, a regulatory pathway where the company submits substantial data regarding the thermometer. If the FDA determines that the device is functional, unlikely to pose harm, and substantially similar to other FDA-approved clinical infrared thermometers, it can grant clearance for sale. Without this clearance, Google cannot enable the Pixel 8 Pro to provide body temperature readings, even if the device is technically capable of doing so.
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Body temperature is indeed a valuable indicator for assessing one’s health, as a fever often signifies illness. This medical information can influence the type of medical care you receive. Since body temperature data falls under the umbrella of medical data, as part of the FDA clearance process, Google must demonstrate that its data privacy practices align with the Health Insurance Portability and Accountability Act (HIPAA). This likely explains why the body temperature data will be stored in Fitbit, rather than your Google account. Fitbit’s data is segregated, and the company has the capacity to comply with HIPAA regulations, ensuring the security and privacy of this sensitive medical information.
The precise rationale behind Google’s decision to incorporate a temperature sensor into the Pixel 8 Pro and its pursuit of FDA clearance for body temperature readings remains shrouded in mystery. Despite inquiries directed at multiple Google spokespeople, the responses provided have been consistently evasive, with each spokesperson essentially reiterating that they’ve submitted an FDA application to enable users to employ the Thermometer App separately to measure their temperature and save the data to Fitbit.
Speculation abounds regarding the potential uses of FDA-cleared body temperature data. It could potentially serve in illness prediction and cycle tracking, as seen with other companies utilizing wearable temperature sensors. Alternatively, Google might be laying the groundwork for future medical technology endeavors. Another possibility is that Google intends to target the healthcare sector, aiming to supply hospital systems with a fleet of Pixel devices.
The situation surrounding the Pixel 8 Pro’s temperature sensor does bear a resemblance to the skin temperature sensor found in the Galaxy Watch 5 and 6 by Samsung. In both cases, these sensors were initially introduced with the potential to measure body temperature but are being utilized for other purposes that require less regulatory clearance. It appears as though the companies added these sensors with the intention of eventually tracking body temperature but are exploring alternative uses for them while navigating the intricacies of FDA approval.
Indeed, obtaining FDA clearance can be a protracted process. For instance, the first Withings ScanWatch encountered a delay of nearly two years before going on sale in the US while awaiting clearance for its EKG and blood oxygen features, which took 16 months. It’s worth noting that even though the ScanWatch 2 features an infrared temperature sensor, Withings, similar to Samsung, is leveraging the data indirectly to avoid the need for FDA clearance. As of now, no smartwatch or phone has secured FDA clearance to offer body temperature data through an infrared sensor. This uncertainty makes it challenging to predict how long it might take for the Pixel 8 Pro to receive the necessary clearance.
In the interim, owning a $1,000 phone with a unique temperature-sensing capability certainly adds a cool party trick to its repertoire.
