Digital Pathology AI
AI applied to tissue, cell, and slide based diagnosis: whole slide image analysis, cell classification and counting, and prognostic or predictive models derived from pathology images. The category is distinct from radiology imaging in what it analyzes and in how it is regulated, and regulatory status is the first thing a buyer should establish rather than the last. Many products sold and used in the United States today are labelled Research Use Only, meaning they may not be used for clinical diagnostic purposes even where the same product carries a CE mark in Europe and even where the vendor is generating revenue. Research Use Only is not a stage of development, it is a permitted use restriction, and a platform being commercially available says nothing about whether its outputs may inform a diagnosis. Buyers should also separate the workflow layer from the algorithms, since several vendors operate open platforms hosting third party models with differing regulatory status on the same screen, and should confirm whether detection thresholds are vendor fixed or customer configurable, because a tunable sensitivity threshold moves part of the clinical risk decision onto the laboratory.
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ArteraAI
Note on naming: this is Artera of Los Altos, California (artera.ai), developer of multimodal AI cancer tests. It is unrelated to the separately indexed Artera of Santa Barbara (artera.io), which makes patient communication agents. The two companies share a name and nothing else. The ArteraAI Prostate Test is a multimodal artificial intelligence model combining digitized histopathology images from an existing biopsy with structured clinical data including age, PSA, and tumor stage, producing a continuous risk score from 0 to 1 with pre established cut points corresponding to roughly 3 percent and 10 percent estimated ten year risk of distant metastasis. It requires no additional procedure because it reads tissue already taken. Beyond prognosis it is predictive: for NCCN intermediate risk patients it estimates whether adding short term androgen deprivation therapy to radiation will reduce risk, which the literature describes as the first predictive biomarker for that decision. The algorithm is pre established and locked at version 1.2, developed from large datasets and multiple phase 3 randomized trials with up to 15 years of follow up. Regulatory and guideline standing is unusually complete: FDA De Novo marketing authorization in August 2025, inclusion in the NCCN Clinical Practice Guidelines for Prostate Cancer as the first and only AI risk stratification tool, and CMS coverage with a payment rate effective January 2024. In June 2026 the company introduced a digital pathology based test providing individual risk estimates in metastatic hormone sensitive prostate cancer. Co-founded by Felix Y. Feng of UCSF; CEO Andre Esteva.
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— | Los Altos, California | Jul 19, 2026 |
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Techcyte
AI digital pathology platform spanning human, veterinary, and environmental laboratories, developing in this field since 2013. Techcyte Fusion is positioned as the first digital workflow integrating anatomic and clinical pathology in one platform, with deep learning models identifying parasitic cells, bacteria, and cancer cells, plus digitization enabling remote case review. Product areas include parasitology, bacteriology, hematology with a peripheral blood smear classifier, cervical cytology, and bladder cancer surveillance. Regulatory status is the decisive buyer fact and the company states it plainly: the anatomic and clinical pathology platform and its human products are Research Use Only in the United States, while Fusion carries CE-IVDD marking in Europe. The architecture is deliberately open rather than proprietary, connecting to numerous slide scanners, laboratory information systems, and third party AI developers through a Fusion Partner Program; one such partner, Modella AI, brought its PathChat research copilot to the platform and was subsequently acquired by AstraZeneca in January 2026. A long running Mayo Clinic collaboration provides access to the Safe Harbour dataset of more than 17 million de-identified slides and pathology reports for model development. The company reports its veterinary segment is already profitable, with human and environmental segments targeted for profitability by 2027, and raised $15 million to expand the platform. Headquartered in Orem, Utah; CEO Ben Cahoon.
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2013 | Orem, Utah | Jul 19, 2026 |