The U.S. Food and Drug Administration (FDA) has listed more than 1,500 artificial intelligence-enabled medical devices authorized for marketing in the United States, reflecting the growing integration of AI across healthcare, including cancer detection, diagnosis, prognosis, surgery, pathology, and radiation oncology.
The FDA’s AI-Enabled Medical Devices List includes technologies that have met applicable premarket requirements through regulatory pathways including 510(k) clearance, De Novo authorization, and Premarket Approval (PMA).
The agency emphasizes that the list is not comprehensive. Devices are primarily identified based on AI-related terminology appearing in publicly available marketing authorization documents and device classifications, and the list is updated periodically as additional devices are identified.
AI Is Already Entering Different Areas of Cancer Care
Several technologies included in the FDA list have direct applications in oncology.
One of the most recent examples is Perimeter Medical Imaging AI’s Claire OCT System, which received FDA Premarket Approval on March 3, 2026. The system combines optical coherence tomography with an AI-based computer-aided detection algorithm to identify and mark areas suspicious for breast cancer in excised lumpectomy tissue. It is intended to be used alongside standard methods for evaluating surgical margins in patients with biopsy-confirmed breast cancer.
Another example is RevealAI-Lung, developed by RevealDx, which received 510(k) clearance on January 30, 2026. The software analyzes lung CT images and provides computer-aided diagnostic information about pulmonary nodules. It generates a malignancy similarity score designed to assist radiologists in assessing the cancer risk of incidentally detected lung nodules. The software is intended to complement other clinical information rather than provide an independent diagnosis.
AI is also moving beyond cancer detection. ArteraAI Prostate, developed by Artera, received De Novo authorization in July 2025. The software analyzes digital histopathology images from prostate biopsies and provides estimates of the 10-year risks of distant metastasis and prostate cancer-specific mortality. It is intended to support prognostic decision-making in patients with non-metastatic prostate cancer.
Breast imaging is another area with multiple AI-enabled technologies. MammoScreen, developed by Therapixel, uses artificial intelligence to assist radiologists in interpreting mammograms, identifying suspicious findings and providing associated suspicion scores. Different generations of the technology have received FDA clearance, including MammoScreen 4 in July 2025.
Digital pathology is represented as well. Paige Prostate, which received De Novo authorization in 2021, was designed to assist pathologists in identifying areas suspicious for cancer in digitized prostate biopsy slides.
AI applications are also extending into treatment. The FDA list includes the Radiation Planning Assistant, developed by The University of Texas MD Anderson Cancer Center and cleared in 2023, alongside a growing number of AI-enabled segmentation, contouring, imaging, and radiation treatment-planning technologies.
The latest entries further illustrate how quickly the field is evolving. Among the devices added in 2026 are technologies such as InferCare RECIST, as well as several AI-enabled radiology and radiation therapy systems.
The Growing List Is Also Raising Questions
The expanding number of FDA-authorized AI-enabled devices has also prompted discussion about how artificial intelligence is entering clinical workflows and how oversight will evolve as these technologies become more capable.
Commenting on the development, Roupen Odabashian, Oncologist at Abbotsford Regional Hospital and Cancer Centre, Founder of MeDucation AI, and Podcast Host at OncoDaily, highlighted the contrast between the highly specific AI algorithms represented on the FDA list and the broader AI technologies increasingly being used in clinical practice.
He wrote:
“The tools that are transforming practice fastest are precisely the ones with the least oversight, while the narrow, locked, single-task algorithms carry the approvals.”
The FDA itself continues to develop its approach to artificial intelligence. The agency states that its AI-enabled medical device list is intended to increase transparency for healthcare professionals, patients, and developers while providing insight into the evolving regulatory landscape.
But as the number and capabilities of these technologies continue to grow, will AI-enabled medical devices translate into meaningful improvements in everyday oncology practice and patient outcomes?
Read further on OncoDaily: FDA Grants Accelerated Approval to Iberdomide Combination for Multiple Myeloma Based on MRD-Negative CR
