First-Ever FDA Approval for Smartphone-Connected Oral Thermometer

New type of thermometer does much more than just take a temperature, tracks spread of flu

Kinsa, a mission-driven, venture-backed startup, today announced 510(k) clearance for its smartphone-connected thermometer by the U.S. Food and Drug Administration (FDA). This announcement marks the first-ever approval by the FDA for a mobile-connected version of the world’s most common medical device.

Like traditional thermometers, the Kinsa Smart Thermometer can be used orally, under-the- arm or rectally. It’s been designed with parents and children in mind and leverages the smartphone to make taking a temperature a more engaging and informative process. The thermometer connects to a smartphone or other mobile device via the headphone jack and uses the display, power and processing of the smartphone to determine a precise temperature reading — with fewer components in the thermometer, it is compact, thin, and highly flexible, making it more comfortable to use. Kinsa uses the smartphone’s display screen to provide fun, animated visuals throughout a temperature reading – calming, distracting and engaging children throughout the process. The display also shows reading progress and alerts parents if the thermometer slips out of place. Users can create individual profiles for the whole family and, with a few taps, track their fever, symptom and illness history.

Kinsa is adding additional software features and, as its user base grows, will provide alerts when there is an illness outbreak in the user’s local area or at her child’s school. “By combining a thermometer with a smartphone, we’ve created a communication channel with the ill, providing users with far more value than today’s thermometers can,” explained Inder Singh, founder and CEO of Kinsa. The company’s ultimate goal is to create the ‘health weather’, a real-time understanding of what illnesses are spreading and where. The company will accomplish this by combining data from its products with other sources. Kinsa aspires to work closely with health agencies like the U.S. Centers for Disease Control, the World Health Organization, and state and local health departments to accomplish its mission.

Singh explains, “With the Kinsa Smart Thermometer, we can transform the way people care for their families. And by piggy-backing off of the most widespread medical behavior in the world – a parent taking a child’s temperature at the first sign of illness, even before scheduling a doctor’s appointment – we can simultaneously create a highly accurate, first- of-its-kind system to track the spread of illness, revolutionizing health across the globe.” Children are often the earliest to get sick from a contagious illness like the flu and can spread it rapidly, so a real-time, geo-located understanding of early illness indicators like fever and symptoms, can help to stop the spread.

“The world is seeking better ways to track infectious disease both at the level of the individual and the community. Kinsa’s approach is exciting because it engages consumers – it can provide real value for individuals – and at the same time aggregates information in a way that could help predict and hopefully prevent illnesses like influenza” explained Ken Staley, MD, former White House Director for Biodefense and an advisor to Kinsa.

Kinsa will conduct a private beta test of its device and mobile app in early January. Kinsa is currently taking pre-orders for delivery in March or April on its website (www.kinsahealth.com), selling the Kinsa Smart Thermometer initially at a price of $14.99.