Table 1.
Food and Drug Administration (FDA)-approved applications for breast imaging*.
| Tool (Company) | Modality | Application | Date of Approval |
|---|---|---|---|
| MammoScreen (Therapixel)10 | Mammography | Lesion detection and classification | 3/25/2020 |
| Genius AI Detection (Hologic)11 | Mammography | Lesion detection and classification | 11/18/2020 |
| ProFound AI Software V3.0 (iCAD)12,13 | Mammography | Lesion detection and classification | 3/12/2021 |
| Transpara 1.7.0 (ScreenPoint Medical B.V.)14 | Mammography | Lesion detection and classification | 6/2/2021 |
| Lunit INSIGHT MMG (Lunit)15 | Mammography | Lesion detection and classification | 11/17/2021 |
| cmTriage (CureMetrix)16 | Mammography | Triage | 3/8/2019 |
| HealthMammo (Zebra Medical Vision)17 | Mammography | Triage | 7/16/2020 |
| Saige-Q (DeepHealth)18 | Mammography | Triage | 4/16/2021 |
| Quantra 2.1/2.2 (Hologic)19 | Mammography | Density assessment | 10/20/2017 |
| Insight BD (Siemens Healthineers)20 | Mammography | Density assessment | 2/6/2018 |
| DM-Density (Densitas)21 | Mammography | Density assessment | 2/23/2018 |
| DenSeeMammo (Statlife)22 | Mammography | Density assessment | 6/26/2018 |
| densityai (Densitas)23 | Mammography | Density assessment | 2/19/2020 |
| WRDensity (Whiterabbit.ai)24 | Mammography | Density assessment | 10/30/2020 |
| Visage Breast Density (Visage Imaging GmbH)25 | Mammography | Density assessment | 1/29/2021 |
| Powerlook Density Assessment V2.1/V4.0 (iCAD)26 | Mammography | Density assessment | 7/12/2021 |
| Volpara Imaging Software (Volpara Health Technologies Limited)27 | Mammography | Density assessment | 7/27/2021 |
| ClearView cCAD (ClearView Diagnostics)42 | Ultrasound | Lesion classification | 12/28/2016 |
| Koios DS (Koios Medical)43 | Ultrasound | Lesion classification | 7/3/2019 |
| QuantX (Qlarity Imaging)56 | MRI | Lesion classification | 5/17/2017 |
*
Based on FDA documents and the American College of Radiology website4.