Devices · Artera Inc.

ArteraAI Prostate

Artera Inc. is listed for ArteraAI Prostate (DEN240068). The FDA list gives July 31, 2025 as the date of the final decision. The lead panel is Pathology, and the database link on the FDA list is the De Novo pathway. openFDA describes product code SFH as “Pathology Software Algorithm Device Analyzing Digital Images For Prostate Cancer Prognosis”: A pathology software algorithm device analyzing digital images for prostate cancer prognosis is a software intended to analyze digital images of acquired from medical imaging devices (for example but not limited to - whole slide imaging scanners). The device provides prognostic risk estimates which are intended to assist physicians with prognostic risk-based decisions along with other clinicopathological factors. The device is not intended to determine a clinical diagnosis. openFDA records this submission’s decision description as “Unknown.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN240068

Official FDA database record

Date of final decision

July 31, 2025

Company on the FDA list

Artera Inc.

Lead panel

Pathology

Primary product code

SFH

openFDA device name for the code

Pathology Software Algorithm Device Analyzing Digital Images For Prostate Cancer Prognosis

Device class

2

Regulation number

864.3755

openFDA decision description

Unknown

openFDA decision code

DENG

Statement or summary label

Not returned