A Rhode Island patient advocacy group for chronic pain sufferers has petitioned the US Food and Drug Administration to classify and regulate a proprietary risk-scoring algorithm from Boston-based Bamboo Health as a software as a medical device, or SaMD.
US FDA Should Regulate ‘Dangerous’ Prescription Software Platform As A Medical Device, Says Patient Advocacy Group
The Doctor Patient Forum says the US FDA should regulate a scoring platform from Bamboo Health intended to help clinicians calculate risk for opioid abuse as a medical device to ensure patient safety.
