FDA loosens oversight of AI decision-support software and health wearables

FDA issued revised final guidances on clinical decision support software and general wellness products without a prior comment round. The CDS guidance adds enforcement discretion for software that gives a single recommendation or risk score if clinicians can review its basis, and the wellness guidance lets non-invasive wearables report measures such as blood pressure, oxygen saturation or glucose-related signals without device review if they avoid disease claims.