Acumen Hypotension Prediction Index – EV1000 Clinical Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform - Pressure
Edwards Lifeciences, LLC
Acumen Hypotension Prediction Index – EV1000 Clinical Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform - Pressure is cataloged as an AI-enabled cardiovascular diagnostics product associated with cardiovascular workflows. Source records identify Edwards Lifeciences, 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
Catalog status
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.
Product facts
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Inferred from category/workflow metadata — do not publish as verified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 (K183646); the latest listed decision date is 2019-05-21. Product-family mapping, current marketing status, and the exact authorized scope require decision-record review.
Sources represented
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
01Which patient populations, acquisition conditions, and reference standards were validated?
02How often do errors change diagnosis, triage, testing, or treatment decisions?
03How is performance monitored across sites, devices, subgroups, and software updates?