Comment from Yvonne Helmick
AnonymousSupportAdvocacy
Summary: The Center for U.S. Policy is submitting a citizen petition requesting that the FDA deem Bamboo Health's NarxCare software a misbranded medical device. They argue that the software lacks proper regulatory oversight, uses flawed algorithms that can lead to adverse health consequences for patients, and may result in discriminatory treatment of marginalized groups.
Narxcare should be regulated by the FDA, according to this article it has The validation study found that the NarxCare scores had a false-positive rate of 17.2% and a false-negative rate of 13.4%.