Baby biometric monitoring devices are various forms of electronics or straps you attached to your sleeping baby. These devices purport to be able to track breathing, oxygen levels, and more — though as mentioned above many have failed independent testing. As of November 2024, none of these at home devices are FDA Approved.

Physicians, researchers, and the American Academy of Pediatrics advise against using these devices because “there are no medical indications for monitoring healthy infants at home” and these devices reduce adherence to safe sleep practices, increasing the risk of harm. These devices cannot be relied upon for medical guidance (as clearly stated in all of their legally mandated disclaimers) and create a simmering anxiety with parents obsessively checking unreliable data. If your child requires medical oversight, then they should receive it from doctors and FDA Approved medical devices.

Another concern is that terminology like “FDA cleared” can give parents a false sense of security. However, when a device is “cleared” by the Food and Drug Administration, that designation doesn’t mean the FDA has approved or even extensively reviewed the device. The same is true for general wellness products.

The reality is that these companies' marketing language does not match their medical language. They advertise ultimate peace of mind because of "medical grade technology," but to the medical community and in FDA regulatory filings, they directly acknowledge their devices cannot be relied upon for accurate medical information.

These devices are "Class II" on the FDA's 3-level risk scale, which means they undergo "FDA Clearance"  that doesn't require clinical trials because the device is "substantially equivalent" to existing technology or is used in low-risk applications—a much lower level of review than the "FDA Approval" process that Class III devices (for lifesaving care) are required to complete. Given this, these companies should not be advertising that their products can provide the "ultimate peace of mind" and "monitor every breath," especially in light of how they are weaving these marketing claims together with their implications. 

Some of Owlet’s offerings fall under the FDA cleared category. However, Owlet began marketing one of its products without FDA clearance. It then received an FDA warning letter in 2021 that it was in violation and needed to undergo 510(k) clearance.

Other smart monitors and apps fall under the general wellness products category. The FDA defines these as “intended for maintaining or encouraging a healthy lifestyle” and “unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition.” Nanit falls under this general wellness category.

Courtesy of Harbor.co

Parents deserve better than fear-based marketing tactics designed to exploit their anxieties. Baby biometric devices are promoted as life-saving innovations, but the reality is quite different. These products aren’t backed by solid science, nor do they have the support of the medical community. Instead, they increase fear and anxiety, creating more stress for parents during an already vulnerable time.

By signing the petition, you’ll help:

1. Raise Awareness: Join a collective voice exposing the truth about these devices, which don’t prevent tragedy but can increase parental stress and lead to unsafe sleep practices.

2. Demand Accountability: Help us push baby tech companies to align their marketing with science, transparency, and ethical practices, rather than capitalizing on fear.

3. Support Families: Parents deserve real solutions and support, not false security. By signing, you’re advocating for a change that prioritizes family well-being over corporate profits.

Together, we can demand change from companies that can and should know better. We can help create a healthier, more supportive environment for families. Sign and share this petition to be a part of the positive change all families deserve. Your involvement matters!