Epic's widely used deterioration-prediction tool gets its first FDA clearance
The FDA cleared Epic's Deterioration Index Version 2 through the 510(k) pathway on September 18, 2026, finding it substantially equivalent to AgileMD's eCARTv5. The tool, embedded in Epic's EHR, uses 195 chart inputs (vitals, labs, nursing assessments, medications, diagnoses) to produce a 0-100 score estimating a hospitalized or ED observation patient's risk of death within 72 hours or need for escalated care within 24 hours. It is Epic's first clearance through the FDA's device center and its first for an AI/ML model; the tool had been running inside hospitals for years without that review.
Why it's notable: Thousands of hospitals already use the Deterioration Index to flag at-risk inpatients, so bringing it under FDA review for the first time sets a marker for how long-deployed, EHR-embedded prediction models can operate before regulators weigh in.