VivaLnk, a Santa Clara-based connected health startup, has received FDA clearance for its first device, a peel-and-stick continuous thermometer for children called Fever Scout. VivaLnk announced Fever Scout at CES 2015 and originally planned to launch it that year, but has delayed the launch more than once. FDA clearance could mean the device will finally hit the market soon.
Update: VivaLnk reached out to MobiHealthNews to explain the delays. According to a spokesperson, they were due to a change in FDA guidelines in mid-2015. Connected thermometers were originally considered exempt, and VivaLink executives felt they were probably grandfathered in, but when the guidance was changed the company chose to proactively seek clearance to be on the safe side.
Fever Scout takes the form of a soft, flexible patch worn under an infant or child's arm. The device is designed to continuously monitor a child's body temperature and send the results via Bluetooth to a parent's smartphone. The patch has a rechargeable battery and a long range, allowing parents to monitor their child's temperature from up to 100 feet away.
The company has the patch listed on its website for $69, and sells replacement adhesives for $7.99 -- although at the moment, the product is not yet available to order.
VivaLnk may not be selling Fever Scout yet, but it's already promoting its second generation device, Vital Scout, which was announced at CES 2016, more than a year ago. While Fever Scout measures only temperature and is designed for children, Vital Scout uses the same eSkin technology to measure a wider range of vital signs, including ECG, for adults. It promises to measure body temperature, respiration rate, sleep status, heart rate, stress levels, and activity.
The first FDA clearance for a continuous thermometer like this went to Chinese company Raiing back in 2012. That device, originally aimed at the consumer, is now being used in enterprise contexts, including a pilot with Partners Healthcare a few years ago.
Fever Scout's FDA clearance comes at a time when baby tech, using connected devices to monitor infants for parents' peace of mind, has recently come under some scrutiny. In a JAMA article last week, researchers outlined how the proliferation of baby wearables that monitor vital signs and alert parents of abnormalities via a companion app can cause undue alarm to parents. Moreover, the researchers point out, the devices have no evidence of medical benefits.