We want to reduce the risk of Sudden Infant Death Syndrome (SIDS) with our novel product. Our device is a pulse-oximetry based rescue garment worn by an infant on the hand. The device monitors heart rate and blood oxygenation. Detecting and interrupting dangerous sleep episodes is theoretically the best mechanism of rescue for infants at risk due to SIDS. If the wearer experiences a dangerously low heart rate and/or blood oxygen saturation episode, he/she will experience a safe electrical stimulation that will effectively rouse them. The rescue stimulus is minimal so as not to cause undue distress.
It is important to note, however, that the Anti-SIDS device provides a live saving intervention. It communicates wirelessly with the caregiver's tablet or smartphone, where an application resides with a user interface. Data are gathered that may be shared wirelessly with physicians on either a real-time, or a scheduled basis. It is extremely important to note that the device makes diagnostic and treatment in the same moment that a critical situation is happening. The baby does not need the action of the caregivers to save his life. The wearable device will intervene finishing the problem.
An estimated 1966 infants in the US die each year of Sudden Infant Death Syndrome. There are currently no FDA authorized therapies to address this urgent and unmet medical need. The customer we benefit desires assurance that their infant survives any life threatening sleep events that may occur. Our customer is typically the medically insured parent of an infant who relies upon non-parental childcare for more than 10 hours/week, and who wishes to continually monitor their infant’s sleep.