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Paige

Digital pathology AI holding the first FDA De Novo authorisation for a pathology algorithm, now part of Tempus

As of 1 September 2026, Paige's pricing is not published; the vendor quotes on request. Paige Prostate Detect was the first AI pathology product authorised by the FDA, and it is authorised only as an adjunct on prostate core needle biopsies viewed through Paige FullFocus. Softwr lists it under Healthcare. Paige is made by Paige AI, Inc., a Tempus company, available on Web, Self-hosted.

Overview

What Paige does

Paige builds AI applications for computational pathology, spun out of Memorial Sloan Kettering. Its clinical products cover prostate, breast, lymph node and other tissue types, with the Paige Prostate suite comprising Detect, Grade and Quantify and perineural invasion. FullFocus is the accompanying whole slide viewer. Alongside the clinical line, Paige sells foundation models and OmniScreen products into biopharma for prescreening and biomarker characterisation, and has introduced Alba as a multimodal pathology copilot. The regulatory position is the reason Paige matters and also the reason buyers overestimate it. In September 2021 Paige Prostate received the first ever FDA De Novo marketing authorisation for an AI pathology algorithm. The authorised indication is narrow and specific: an adjunct to review of digitised prostate core needle biopsy slides scanned on a compatible scanner and viewed through the FullFocus viewer, identifying areas of interest for pathologist review. It does not diagnose, it does not grade under that authorisation, and it does not extend to other tissue types. In Europe the Paige Prostate suite obtained IVDR certification in 2025, which is a broader position covering grading and quantification. The pivotal study reported that pathologists using the software detected cancer on individual slides more often, with reported reductions in false negative and false positive readings. Buyers are hospital and reference pathology laboratories that have already digitised, plus pharmaceutical companies buying the research side. The trade off is prerequisite cost. Paige is useless without whole slide scanning, image storage and a digital pathology workflow already in place, and that infrastructure typically costs an order of magnitude more than the algorithm. Tempus acquired Paige in 2025, so contracting, support and roadmap now sit inside a larger precision medicine business with its own commercial priorities around genomic data.

What people use it for

  • A reference laboratory processing high volumes of prostate core needle biopsies where a second read on every case is not staffable
  • A pathology department already digitised that wants a documented safety net against missed small foci of cancer
  • A hospital laboratory struggling to recruit uropathology subspecialists and needing consistency across generalist reporting
  • A pharmaceutical company needing consistent biomarker scoring across trial sites rather than site-by-site pathologist variability

The honest half

Where it falls short

Concrete and checkable, so you can decide whether any of them matter to you. This is the half of a review a vendor will not write about Paige.

  • The FDA authorisation is confined to prostate core needle biopsies, on compatible scanners, viewed through FullFocus, as an adjunct only; every other tissue type and every grading claim is outside that authorisation in the United States.
  • The algorithm is worthless without a digital pathology programme already running, and slide scanning, storage and workflow typically cost far more than the software licence.
  • Tempus acquired Paige in 2025, so the roadmap now competes for attention inside a genomics-led business, and the pathology-only buyer is no longer the primary customer.
  • Scanner compatibility is a hard constraint rather than a preference, and a laboratory with an unsupported scanner fleet cannot use the authorised indication at all.
  • Pricing is per case or per slide and unpublished, so a laboratory cannot model cost per reported case without entering a sales process.

Cross-shopped

What people choose instead of Paige

Each pairing was judged by two reviewers asking whether a buyer would genuinely weigh the two against each other. The ones that failed were deleted rather than published.

  • Paige logo
    Paige
    vs
    Ibex Medical Analytics logo
    Ibex Medical Analytics

    Ibex Medical Analytics: If you want a pathology AI vendor whose primary business remains pathology rather than genomics

  • Paige logo
    Paige
    vs
    Sectra logo
    Sectra

    Sectra: If the immediate need is the digital pathology workflow and archive rather than the algorithm

  • Paige logo
    Paige
    vs
    Benchling logo
    Benchling

    Benchling: If the requirement is research data management rather than clinical diagnostic support

Pricing

What Paige costs

Taken from the vendor's own pricing page. Prices move, so check before you buy.

Paige clinical applications

On request

  • Priced per case or per slide analysed under annual agreement
  • Prostate, breast and other applications licensed separately
  • Requires compatible whole slide scanner and the FullFocus viewer for the authorised indication
  • Life sciences foundation model access contracted separately

Capabilities

Features

  • Paige Prostate Detect

    FDA De Novo authorised adjunct for identifying suspicious areas on prostate core needle biopsies

  • Paige Prostate Grade and Quantify

    Gleason grading and tumour quantification, available under IVDR in Europe

  • Perineural invasion detection

    Flags perineural invasion on prostate specimens

  • Breast and lymph node applications

    Cancer detection and metastasis identification on breast tissue

  • FullFocus viewer

    FDA cleared whole slide viewer required for the authorised prostate indication

  • Foundation models

    Pathology foundation models licensed for research and product development

  • OmniScreen

    Prescreening and biomarker characterisation products aimed at biopharma

  • Paige Alba

    Multimodal pathology copilot spanning slide, report and clinical context

Answered, with sources

Questions people ask

Each answer names the page it came from, so you can check it rather than take our word for it.

What exactly is FDA authorised?

Paige Prostate Detect, as an adjunct for identifying areas of interest on digitised prostate core needle biopsy slides, viewed through the Paige FullFocus viewer on a compatible scanner. Nothing else in the portfolio holds that authorisation in the United States.

Is the European position broader?

Yes. The Paige Prostate suite including grading and quantification received IVDR certification in 2025, which covers more than the United States authorisation.

What did the pivotal study measure?

Pathologist cancer detection on individual slide images improved, with reported reductions in false negative and false positive readings. It measured pathologist performance with the tool, not standalone algorithm accuracy.

Who owns Paige now?

Tempus AI acquired Paige in 2025. Products remain branded Paige.

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Softwr does not host reviews and shows no star rating for Paige, because a rating we did not collect is not ours to publish. What is here is the pricing and platform detail from the vendor’s own pages, limitations we could state concretely, and alternatives a reviewer confirmed people weigh against it. Tell us if any of it is wrong.

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