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Acumen Hypotension Prediction Index (HPI) Feature Software

Edwards Lifesciences LLC

Acumen Hypotension Prediction Index (HPI) Feature Software is cataloged as an AI-enabled cardiovascular diagnostics product associated with cardiovascular workflows. Source records identify Edwards Lifesciences LLC as the associated developer or manufacturer.

Designed for

Cardiologist and clinical team

Care setting

Cardiology, imaging, and acute-care workflows

Specialty

Cardiovascular

Catalog record · evidence not yet assessedCatalog updated 2026-08-31

Evidence not yet characterized

This catalog entry is based on 1 public source record. RIR has not yet characterized the product's clinical evidence.

This is a catalog and scoping record. RIR has not completed a public-evidence assessment of this product. Inclusion is not endorsement, verification, certification, or a recommendation.

What the source record supports

The linked sources support catalog inclusion and identify the product and associated organization. They do not constitute an RIR evidence assessment.

What still needs verification

Current product-family mapping, exact intended use and version, present availability, independent performance, subgroup behavior, workflow effects, safety monitoring, and patient outcomes may remain unresolved.

Working intended-use description
Support cardiologist and clinical team in cardiology, imaging, and acute-care workflows within the source-described cardiovascular diagnostics workflow.
Intended-use status
Inferred from category/workflow metadata — do not publish as verified
Represented version
Public sources accessed 2026-08-31; represented software version not established
Regulatory context
FDA's AI-Enabled Medical Device List contains 1 record for this candidate (DEN160044); the latest listed decision date is 2018-03-16. Product-family mapping, current marketing status, and the exact authorized scope require decision-record review.

1 source records used to identify or scope this catalog entry.

For clinical and investment reviewEvidence context and questions for deeper review

Current source base

This catalog entry is based on 1 public source record. RIR has not yet characterized the product's clinical evidence.

Important limitation

Current product-family mapping, exact intended use and version, present availability, independent performance, subgroup behavior, workflow effects, safety monitoring, and patient outcomes may remain unresolved.

Questions to ask

  1. 01Which patient populations, acquisition conditions, and reference standards were validated?
  2. 02How often do errors change diagnosis, triage, testing, or treatment decisions?
  3. 03How is performance monitored across sites, devices, subgroups, and software updates?