Pathology · De Novo · 2025
ArteraAI Prostate
Artera Inc.. Granted by FDA on 31 July 2025 under submission DEN240068, product code SFH (pathology software algorithm device analyzing digital images for prostate cancer prognosis). What FDA's record says, in FDA's words.
Device record · DEN240068
- Device. ArteraAI ProstateDEVICE
- Company. Artera Inc.COMPANY
- Decision. 31 July 2025, De NovoDECISION
- Panel. PathologyPANEL
- Product code. SFH, Pathology Software Algorithm Device Analyzing Digital Images For Prostate Cancer PrognosisCODE
- Regulation. 21 CFR 864.3755, Class IIREG
- Source. FDA database entry · decision document (24 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA granted it for
The Indications for Use statement, verbatim, from the decision document.
A. Indication(s) for Use: ArteraAI Prostate is a software only device intended to analyze scanned histopathology whole slide images (WSIs) from treatment-naïve prostate core needle biopsies prepared from formalin fixed paraffin-embedded (FFPE) tissue and stained using Hematoxylin & Eosin (H&E) stains. ArteraAI Prostate provides 10-year risks of distant metastasis and prostate cancer specific mortality and is intended to assist physicians with prognostic risk-based decisions along with other clinicopathological factors in non-metastatic prostate cancer patients. ArteraAI Prostate is intended for males 55 years of age or older without clinically or pathologically defined metastases, and who are candidates for curative intent management (surgery, radiation therapy with or without systemic therapy, or active surveillance). ArteraAI Prostate is intended to utilize WSIs acquired from an FDA-cleared interoperable scanner with which ArteraAI Prostate has been authorized for use or a 510(k)-cleared scanner that has been assessed in accordance with the Predetermined Change Control Plan (PCCP) for qualifying additional interoperable scanners. B Special Conditions for Use Statement(s): Rx - For Prescription Use Only
The product code's definition, from FDA's classification record. 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.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Modalities namedpathology slides
- Mentionsan adjunct to the clinician, not a replacement
- Mentionsprescription use
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code SFH. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code SFH, in Pathology, from Artera Inc., or granted in 2025. The whole record is at FDA AI-enabled medical devices.
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