Ligence Heart
K252105Ligence, UAB · cleared 2025-09-26 · product code QIH · Radiology
Premarket evidence — what FDA accepted
source quote (p.4)
“Ligence Heart is a fully automated software platform that processes, analyses and makes measurements on acquired transthoracic cardiac ultrasound images, automatically producing a full report with measurements of several key cardiac structural and functional parameters.”
source quote (p.5)
“Ligence Heart automatically identifies standard transthoracic echo views with machine-learning-based view classification, cardiac cycle selection, and border detection, then generates reproducible quantitative left-ventricular volumetric and functional measurements.”
source quote (p.8)
“Test datasets were strictly segregated from algorithm training datasets, as they are from completely separate cohorts.”
source quote (p.8)
“A cybersecurity analysis and testing were conducted to verify that security measures are properly implemented in Ligence Heart to protect Ligence Heart's data, including patient health information (PHI).”
Validation studies (1)
Retrospective clinical
n=524 cases · 1 site(s)
endpoints: Individual Equivalence Coefficient (IEC); Intraclass Correlation Coefficients (ICC)
Reported performance (1 observation)
source quote (p.9)
“Intraclass Correlation Coefficients (ICC) were ≥ 0.90 for all four parameters.”
Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.
Predicate network
Postmarket — what happened after clearance
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K253535 (decision 2026-02-27) from Ligence Uab for a matching device line ("Ligence Heart") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K253535
Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.
Reimbursement — how devices like this got paid
Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).