LO
ConstraintCognitive automation2018-03-16
A hypotension prediction algorithm was classified as an adjunctive indicator that is not intended to independently direct therapy, the US Food and Drug Administration decided
Anaesthesiologist / anaesthetistoccupation page →
Event date / reported
2018-03-16
Evidence stage
ConstraintFailure, rollback, regulation or cost is suppressing adoption. Can lower an assessment or widen its uncertainty.
Tasks this bears on
Watching the patient and responding to deterioration
Reading blood pressure, heart rhythm, oxygen and depth of anaesthesia, and acting before problems become harm.
Being augmented✓ Evidence-backed
Where this applies
United States. The regulator created a new device type, the adjunctive predictive cardiovascular indicator, for software that estimates the likelihood of future cardiovascular events such as low blood pressure. It says the device is intended for adjunctive use with other vital signs and patient information and is not intended to independently direct therapy. The algorithm can warn; the decision to treat stays with the clinician.
What this means
The regulator allows the algorithm to warn but not to decide treatment.
What it does not yet show
A classification decision; it says nothing about how often the device is used or how well it works.
What you can check
Open FDA De Novo decision DEN160044 and find "not intended to independently direct therapy".
Does it change the assessment?
No. The impact index is never moved by a single event. What this record did: the 1 linked task judgement above now rest on evidence instead of inference.
Source
U.S. Food and Drug Administration — De Novo classification order DEN160044 (Acumen Hypotension Prediction Index), March 16, 2018 · verified 2026-09-30 · Claude (VOLO agent) · interpreted 2026-09-30 · Claude (VOLO agent)
Primary source — published by the party that did this, or the authority of record. No co-signature needed.
This record is cited in