Oncology and radiation therapy

AI that drafts organ and lymph node contours for radiation treatment planning, or estimates a prostate cancer patient's risk of metastasis from biopsy slides to guide treatment decisions.

4 tools · Reviewed · How we grade

A radiation therapy machine with a tall stand, an arm and a treatment head over a couch, with an amber beam falling on the couch.
Category overviewHide category overview

Auto-contouring software for radiotherapy is cleared by 510(k) as image processing software that produces draft contours for a professional to review and approve, as in the clearance for MVision's Contour+. Most studies compare drafts with expert contours or time manual drawing against editing. In a randomized study of 97 radiation oncologists, AI templates improved agreement with expert contours, on cases never used for treatment. A seven-institution study found savings of 46% overall but none for several lymph node levels; a failure analysis traced errors to stents, drains and contrast, and accuracy can also change after software updates.

In pathology, FDA granted its De Novo authorization for ArteraAI Prostate in July 2025 for prognosis. A 2025 systematic review of digital pathology AI in urologic cancers found no study that assessed a model prospectively.

Read as an explainer

Grade CAccuracy studies only

AI-Rad Companion Organs RT

Siemens Healthineers

Siemens Healthineers deep learning software that automatically contours organs at risk on CT and MR for radiotherapy planning.

FDA: 510(k) clearance

Full reviewHide full review: AI-Rad Companion Organs RT

The software contours predefined structures, including known brain metastases, on CT and MR images for radiotherapy planning; contours must be reviewed, edited and accepted in planning or contouring software, according to its 2026 clearance, which says it is not for diagnostic use. It locates each organ with landmark detection and then segments it, its developers report.

Why this grade. Studies measured contour quality and editing time, including ratings of 1,366 contours from 156 patients at seven institutions and a time study of 116 cases across 18 Indian centers; each compared AI and manual contours on the same cases rather than measuring an effect on care, which a B would require.

The evidence

In the seven-institution evaluation, 11 physician evaluators rated 65% of contours clinically usable and 31% usable with minor edits; 4% needed major edits or redrawing. Varian Medical Systems employees were among the authors. Across 18 American Oncology Institute centers, six physicians recorded both manual contouring and editing times on 116 cases; the software saved 13.8 minutes per case on average, worth INR 37 to INR 670 net, and one author listed a Varian affiliation.

At a Delaware cancer center, in 30 patients, time savings were 67% for head and neck, 83% for pelvis and 84% for thorax, and an expert rated 50% of head and neck, 72.5% of pelvic and 82% of thoracic contours clinically usable. At a Tokyo hospital, brain, rectum and bladder contours differed significantly across software versions, and rectum accuracy worsened after an update.

FDA
FDA cleared AI-Rad Companion Organs RT through 510(k) K193562 on Nov. 6, 2020, and later versions, most recently K252548 on April 10, 2026, which added contouring of known brain metastases on MRI. The 2026 summary reports retrospective testing against manual reference contours and no clinical testing.
Randomized trial
None published
Key study
Journal of Cancer Research and Therapeutics, 2024, seven-institution contour rating study, 1,366 contours from 156 patients
Limits
Studies were retrospective or rated contours on planning scans, often with vendor-affiliated authors; times were self-recorded, and accuracy for some organs changed after software updates.
Cost
No published price found. checked
Specialties
Oncology
Checked against its sources
Grade BEvidence from clinical use

ArteraAI Prostate

Artera · ArteraAI Prostate Test

Digital pathology AI test that estimates metastasis and prostate cancer death risk from biopsy slides and clinical data.

FDA: De Novo authorization
Cost: Artera's billing flyer lists a typical patient cost of $285 under commercial plans and $0 under Medicare Part B.

Full reviewHide full review: ArteraAI Prostate

ArteraAI Prostate analyzes scanned hematoxylin and eosin slides from prostate biopsies and gives 10-year risks of distant metastasis and prostate cancer death; the authorized device uses only the slide images, FDA's decision summary states. The commercial platform used in an Australian trial also draws on clinical data and reports a predicted benefit from short-term androgen deprivation therapy (ADT).

Why this grade. The ASTuTE interim analysis of 200 men found testing changed 27.5% of shared decisions on short-term ADT, an effect on care; the predictive validations are post hoc analyses of randomized trials, and no randomized trial has compared care with and without the test, so it is not an A.

The evidence

Artera's predictive model drew on 5,727 men from five phase 3 trials and was validated in NRG/RTOG 9408 (1,594 men, median follow-up 14.9 years): ADT reduced distant metastasis in the 34% who were model positive but not in the 1,051 who were negative. The study was supported by National Cancer Institute grants and Artera, whose employees were authors. A long-term ADT model, validated in RTOG 9202 (1,192 men), found benefit in biomarker-positive men (subdistribution hazard ratio 0.55) but not in negative men (1.06).

In ASTuTE, 52 of 74 men (70.3%) who first chose short-term ADT dropped it after testing, while 3 of 126 (2.4%) switched to it; GenesisCare funded the single-arm trial in partnership with Artera. FDA's pivotal study of 886 patients found a 10-year metastasis risk of 28.1% in the high-risk group versus 8.1% overall. A 2025 systematic review counted 10 prostate studies of ArteraAI, none prospective.

Used by
Radiation oncologists at 28 Australian centers used it in the ASTuTE implementation trial, funded by GenesisCare, whose authors, including Artera's chief medical officer, write that the model is a risk stratification option within National Comprehensive Cancer Network (NCCN) guidelines.
FDA
FDA granted the De Novo request for ArteraAI Prostate (DEN240068) on July 31, 2025, classifying pathology software that analyzes digital images for prostate cancer prognosis. The authorized indication covers prognostic risks in men 55 and older without metastases; the decision summary does not mention predicting ADT benefit. The De Novo (DEN240068) covers the image-only prognostic device; the decision summary does not mention the androgen deprivation therapy benefit prediction that the commercial platform reports.
Randomized trial
None published
Key study
Clinical and Translational Radiation Oncology, 2026, ASTuTE single-arm implementation trial, interim analysis of 200 men
Limits
The predictive claims rest on post hoc analyses of archived trials, largely run with Artera; ASTuTE is single arm, open label and partner funded, and reports decisions, not outcomes. FDA authorized prognostic use only.
Cost
Artera's billing flyer lists a typical patient cost of $285 under commercial plans and $0 under Medicare Part B. checked
Specialties
Oncology
Checked against its sources
Grade BEvidence from clinical use

Limbus Contour

Limbus AI (Radformation) · Limbus AI

Deep learning auto-contouring software that drafts normal tissue contours on CT and MR for radiation treatment planning.

FDA: 510(k) clearance
Cost: A UK government notice shows Torbay and South Devon NHS awarded a £99,500 contract for a Limbus-AI contouring subscription running from March 2023 to March 2028.

Full reviewHide full review: Limbus Contour

Limbus Contour is locally installed software that segments normal tissues on CT and MR images with locked deep learning models and exports structure sets to the treatment planning system for review, its 2024 clearance says. A Louisiana cancer center identifies it as a product of Limbus AI and Radformation.

Why this grade. A workflow study at two British Columbia cancer centers and a before-and-after study of 260 brachytherapy fractions measured its use in patients' treatment planning, showing minimal editing and shorter planning time; no randomized trial has tested it, so it cannot be an A.

The evidence

At two BC Cancer centers, the software drafted contours for about 551 eligible central nervous system, head and neck and prostate plans from September 2019 to March 2020; in 203 surveys (32% compliance), most organ contours needed minimal edits, with mean satisfaction of 4.1 to 4.6 out of 5. Limbus employees were authors, and editing time was not measured. At Willis Knighton Cancer Center, adding the software and applicator modeling cut planning time for vaginal cuff brachytherapy by 13.7 minutes per fraction and contouring time by 6.8 minutes, though the two tools' effects could not be separated.

In an earlier test set, drafts took 0.6 minutes versus 26.6 minutes for experts on head and neck cases, with accuracy comparable to variation among experts. An independent failure analysis of 111 cases found biliary stents or drains behind four of six liver outliers and barium contrast behind 10 of 12 stomach outliers.

FDA
FDA cleared Limbus Contour through 510(k) K201232 on Aug. 13, 2020, and version 1.8 through K241837 on Oct. 9, 2024. The 2024 summary reports Dice scores on at least 10 test scans per structure and says clinical testing was not required.
Randomized trial
None published
Key study
Radiation Oncology, 2021, clinical workflow study at two BC Cancer centers, about 551 plans and 203 surveys
Limits
The clinical-use studies are survey based, with low compliance, or before-and-after comparisons with a second tool introduced at the same time, and several have company authors; none measured treatment outcomes or toxicity.
Cost
A UK government notice shows Torbay and South Devon NHS awarded a £99,500 contract for a Limbus-AI contouring subscription running from March 2023 to March 2028. checked
Specialties
Oncology
Checked against its sources
Grade CAccuracy studies only

MVision Contour+

MVision AI · MVision AI Segmentation

Deep learning software that drafts organ and lymph node contours on CT and MR scans for radiotherapy planning.

FDA: 510(k) clearance
Cost: An EU procurement notice shows North Estonia Medical Centre awarded MVision AI a €115,000 contract for AI automatic contouring software for radiotherapy planning, including the hardware needed to run it, in April 2026.

Full reviewHide full review: MVision Contour+

Contour+ automatically contours predefined structures on CT and MR images of the head and neck, brain, breast, lung, abdomen and pelvis, producing templates that a medical professional reviews, edits and approves before planning, according to its 2024 clearance, which states that it does not detect lesions or tumors.

Why this grade. A randomized study of 97 radiation oncologists in low- and middle-income countries found Contour+ templates improved agreement with expert contours and cut time for several organs, but on study cases never used for treatment; no study has measured its use in patients' care, which a B would require.

The evidence

In the ELAISA study, run by the International Atomic Energy Agency and Aarhus University Hospital, 23 institutions were randomized to manual or AI-assisted contouring of head and neck cases. Without teaching, AI assistance raised Dice similarity with expert consensus by 0.10 for the oral cavity and 0.07 for the parotid and cut mandible contouring time by 6.60 minutes; 24% of AI contours were accepted unedited.

In a seven-institution study in Singapore and Europe, total head and neck contouring time fell from 81.9 to 44.4 minutes (46%), but lymph node levels IA, IB, III, IVA and IVB showed no significant savings, and at most clinics levels IVA and IVB took longer to edit than to draw. MVision employees were authors and handled scan randomization. In a Cypriot comparison of five systems on 80 patients, MVision's software had a median volumetric Dice of 0.88 and saved 43.6 minutes on average. Twenty French radiation oncologists found MVision's the only one of eight programs whose contours on children's CT scans met their usability threshold.

FDA
FDA cleared MVision AI Segmentation through 510(k) K212915 on May 3, 2022, and Contour+, which added MR models, through K241490 on Oct. 18, 2024, as radiological image processing software for radiation therapy. The 2024 summary reports no numeric accuracy results.
Randomized trial
Yes. ELAISA (JCO Global Oncology, 2024): 23 institutions with 97 radiation oncologists randomized to manual or AI-assisted contouring of head and neck study cases.
Key study
JCO Global Oncology, 2024, ELAISA randomized study, 97 radiation oncologists at 23 institutions
Limits
Evidence comes from test sets and study cases, often small, and the multicenter time study had company coauthors; savings varied by structure and clinic, and no study tracked planning time, plan quality or toxicity in routine use.
Cost
An EU procurement notice shows North Estonia Medical Centre awarded MVision AI a €115,000 contract for AI automatic contouring software for radiotherapy planning, including the hardware needed to run it, in April 2026. checked
Specialties
Oncology
Checked against its sources

Reviews of the published evidence, not medical advice or an endorsement of any product.