Its not a diagnostic if it only categories the risks......could this be a new category?
On Thursday, the FDA granted marketing authorization of Renalytix AI, Inc.’s KidneyIntelX.dkd, an in vitro diagnostic intended to aid in the assessment of risk of progressive kidney function decline in adult patients with Type 2 diabetes and existing chronic kidney disease. KidneyIntelX.dkd works by measuring three analyte components associated with kidney function decline from a patient’s plasma sample. The results of the three measured analytes are combined with three data inputs from the patient’s medical record provided by the ordering physician, and a machine-learning algorithm provides a risk category of low, moderate, or high. KidneyIntelX.dkd is not intended for screening or as a stand-alone diagnostic test.
No standards for Medical AI or Machine Learning... (other than IEC 62304 of course).... may we present: Good Machine Learning Practice for Medical Device Development: Guiding Principles
The U.S. Food and Drug Administration (FDA), Health Canada, and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) have jointly identified 10 guiding principles that can inform the development of Good Machine Learning Practice (GMLP). These guiding principles will help promote safe, effective, and high-quality medical devices that use artificial intelligence and machine learning (AI/ML).