Table 2. Recent FDA approvals for AI applications in lung cancer diagnosis.
| Device name | Data type | FDA summary | Task | Year |
| FDA, Food and Drug Administration; AI, artificial intelligence; CT, computed tomography; DL, deep learning; MRI, magnetic resonance imaging; CADe, computer-aided detection. | ||||
| Riverain ClearRead CT | CT | https://www.accessdata.fda.gov/ cdrh_docs/pdf16/k161201.pdf |
The detection of pulmonary nodules in the asymptomatic population. | 2016 |
| Arterys Oncology DL | CT MRI | https://www.accessdata.fda.gov/ cdrh_docs/pdf17/K173542.pdf |
Segmentation of lung nodules, 3D visualization and cross-comparison of medical images across modalities and time points. | 2017 |
| Philips Lung Nodule Assessment and Comparison Option |
CT | https://www.accessdata.fda.gov/ cdrh_docs/pdf16/K162484.pdf |
Characterization of nodule type, lobe location, quantification of nodule parameters, and comparison over time. | 2017 |
| Siemens AI-Rad Companion (Pulmonary) |
CT | https://www.accessdata.fda.gov/ cdrh_docs/pdf18/K183271.pdf |
Segmentation and volume measurements of identified lung lesions. | 2019 |
| Siemens syngo CT Lung CADe | CT | https://www.accessdata.fda.gov/ cdrh_docs/pdf19/K193216.pdf |
Detection of solid nodules alerts the radiologists to potentially overlooked regions of interest. | 2020 |
| Coreline AVIEW LCS | CT | https://www.accessdata.fda.gov/ cdrh_docs/pdf20/K201710.pdf |
Automatic nodules detection by integration with 3rd party CADe, characterization of nodule location, type and related measurements. | 2020 |
| Infervision InferRead Lung CT.AI | CT | https://www.accessdata.fda.gov/ cdrh_docs/pdf19/K192880.pdf |
Pulmonary nodule detection in asymptomatic patients. | 2020 |
| Optellum Virtual Nodule Clinic | CT | https://www.accessdata.fda.gov/ cdrh_docs/pdf20/K202300.pdf |
Provide lung cancer prediction CNN score and help with tracking, assessment, and characterization of pulmonary nodules. | 2020 |
| MeVis Veolity | CT | https://www.accessdata.fda.gov/ cdrh_docs/pdf20/K201501.pdf |
Detection of solid nodules alerts the radiologists to potentially overlooked regions of interest. | 2021 |
| IMIDEX VisiRad XR | X-ray | https://www.accessdata.fda.gov/ cdrh_docs/pdf22/K223133.pdf |
Identify and mark regions of suspect interest in suspicious lung nodules and masses on chest radiographs. |
2023 |
| Qure.ai qCT LN Quant | CT | https://www.accessdata.fda.gov/ cdrh_docs/pdf24/K240740.pdf |
Provide advanced quantitative characterization of lung nodules, track volumetric growth, and offer detailed 2D and 3D reconstructions. | 2024 |
| Thirona LungQ V3.0.0 | CT | https://www.accessdata.fda.gov/ cdrh_docs/pdf23/K232412.pdf |
3D segmentation and isolation of sub-compartments, density evaluations, volumetric analysis, fissure evaluation and reporting. | 2024 |