Fibresolve

DEN220040

Imvaria, Inc · granted 2024-01-12 · product code QWO · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.2)
“Fibresolve is a Software as a Medical Device (SaMD) for the qualitative disease assessment of DICOM-compliant chest computed tomography (CT) imaging for the detection of image content consistent with patterns found in patients with idiopathic pulmonary fibrosis (IPF).”
Algorithmdeep learning algorithm, 3D deep learning model
source quote (p.2)
“Fibresolve uses a deep learning algorithm that assesses CT images for patterns consistent with specific disease diagnosis, identifying patterns consistent with IPF among cases of Interstitial Lung Disease (ILD). The analysis algorithm is a 3D deep learning model developed and trained using images from multiple facilities.”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedNo

Validation studies (2)

Bench

sample size not stated

Retrospective clinical

n=300 cases

endpoints: device specificity surpass a pre-specified value of 80%; device sensitivity be non-inferior to the EP

Reported performance (3 observations)

sensitivity0.41CI 95% CI: 30-52%
source quote (p.5)
“In the total 300-case dataset, both endpoints were met, with device sensitivity 41% (95% CI: 30-52%)”
specificity0.87CI 95% CI: 81-91%
source quote (p.5)
“and specificity 87% (95% CI: 81-91%)”
ppvas written: “PPV”0.56CI CI: 40-72%
source quote (p.5)
“Table 2: Device Performance per slice thickness Slice Group n Sensitivity Specificity PPV <= 3 mm 137 55% [CI: 39-71%] 82% [CI: 73-89%] 56% [CI: 40-72%]”

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 Radiology 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/DEN220040