Viz HCM

DEN230003

Viz.ai, Inc. · granted 2023-08-03 · product code QXO · Cardiovascular

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.3)
“The Viz HCM is a Software as a Medical Device (SaMD) intended to analyze ECG signals collected as part of a routine clinical assessment, independently and in parallel to the standard of care. Viz HCM is a combination of software modules that consists of an ECG analysis software algorithm and mobile application software module.”
Algorithmmachine learning-based software algorithm
source quote (p.2)
“The Viz HCM ECG Analysis Algorithm (HCM Algorithm) is a machine learning-based software algorithm that analyzes 12-lead electrocardiograms (ECGs) for characteristics suggestive of hypertrophic cardiomyopathy (HCM).”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedYes
source quote (p.3)
“Cybersecurity was reviewed in accordance with the FDA guidance document "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" dated October 2, 2014.”

Validation studies (2)

Retrospective clinical

n=3,196 cases · 3 site(s)

endpoints: sensitivity; specificity; positive predictive value (PPV)

Bench

n=301,106 patients

Reported performance (3 observations)

sensitivity0.684CI 95% CI: 62.8% - 73.5%
source quote (p.6)
“Sensitivity 68.4% (95% CI: 62.8% - 73.5%)”
specificity0.991CI 95% CI: 98.7% - 99.4%
source quote (p.6)
“Specificity 99.1% (95% CI: 98.7% - 99.4%)”
ppvas written: “PPV (prevalence of 0.002)”0.137CI 95% CI: 10.1%-19.9%
source quote (p.6)
“PPV (prevalence of 0.002) 13.7% (95% CI: 10.1%-19.9%)”

Each value carries its own analysis unit and task — never compare or pool across devices. Source: De Novo decision summary PDF.

Predicate network

Postmarket — what happened after clearance

Not yet tracked — the weekly postmarket refresh hasn't snapshotted this device.

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).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to De Novo AI/ML devices in the Cardiovascular panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/DEN230003