Ann Arbor Machine Learning Software Developer Gets FDA Approval For Heart Monitoring Tool
ANN ARBOR—Clinical analytics startup Fifth Eye Inc. announced that the U.S. Food and Drug Administration has granted its “de novo” classification to Fifth Eye’s Analytic for Hemodynamic Instability (AHI). According to the FDA’s website, “De novo” classification means FDA officials believe the new software has “reasonable assurance of safety and effectiveness for the intended use.” Fifth Eye’s






