At-home, infant breathing smartphone monitor startup nabs $7M for consumer launch

The startup is walking a very fine line between consumer and medical devices.   It states the monitor, which includes a sensor-embedded sock and a base station that relays data on heart rate and oxygen saturation via the cloud to a smartphone app, is not a medical device–therefore not requiring regulation by the FDA.  However, it also claims that the pulse oximetry technology it uses is hospital-grade–and the parental worry it seeks to address is potentially life-threatening.  There are an estimated 3,500 cases of sudden unexpected deaths in children under one year old in the United States annually, according to the Centers for Disease Control and Prevention (CDC).

In addition, the infant heart rate and oxygen level data is available via the cloud — presumably to healthcare providers as well as to parents.  The pulse oximetry works via small LED lights shown on the infant’s skin that work by sensing how much light returns to its photo receptor.  The parent’s smartphone app offers lights and buzzers to alert any halt in breathing.

It expects to sell the device directly to consumers for $249.

The venture financing was led by Formation 8 with participation from Carpe Diem VC, a new fund from the founder of Toms Shoes, Blake Mycoskie, as well as Owlet existing investors Azimuth Ventures, ffvc, Eniac Ventures and Peak Capital.  Formation 8’s latest hardware fund is headed by Lior Susan.  “Our new investor, Lior, was able to use the Owlet with his baby, as well as all of our competitors’ products, and he fell in love with the Owlet Monitor,” said Owlet co-founder Jordan Monroe in a statement.  “That was the biggest factor in making this investment happen.”

REFERENCE:  Fierce Medical Devices; 18 AUG 2015; Stacy Lawrence

Leave a Comment