Transparency Registry · product code QDQ
Cancer detection & diagnosis AI: all 39 FDA clearances
Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer. Computer-assisted detection and diagnosis software for lesions suspicious for cancer. This list is generated from openFDA public records and refreshes automatically every week — bookmark it and it stays current.
| Device | Applicant | Decision date |
|---|---|---|
| Transpara (2.1.0) | Screenpoint Medical B.V. | 2026-08-14 |
| CadAI-B Dx | BeamWorks, Inc. | 2026-08-12 |
| See-Mode Augmented Reporting Tool, Breast (SMART-B) | See-Mode Technologies Pty, Ltd. | 2026-07-28 |
| MammoScreen® (5) | Therapixel | 2026-06-26 |
| Saige-Dx | DeepHealth, Inc. | 2026-06-15 |
| DeepHealth ProstateAI | Quantib B.V. | 2026-04-29 |
| Lunit INSIGHT MMG (v1.1.10) | Lunit, Inc. | 2026-04-23 |
| Lunit INSIGHT DBT (V1.2) | Lunit, Inc. | 2026-03-26 |
| Median LCS (internal name) / eyonis LCS (trade name) (1.0) | Median Technologies | 2026-02-06 |
| Saige-Dx | DeepHealth, Inc. | 2025-08-11 |
| Genius AI Detection 2.0 | Hologic, Inc. | 2025-07-31 |
| MammoScreen® (4) | Therapixel | 2025-07-03 |
| QP-Prostate® CAD | Quibim S.L. | 2025-03-18 |
| Prostate MR AI (VA10A) | Siemens Healthcare GmbH | 2025-03-05 |
| Saige-Dx (3.1.0) | DeepHealth, Inc. | 2024-12-19 |
| Transpara (2.1.0) | Screenpoint Medical B.V. | 2024-11-25 |
| Saige-Dx | DeepHealth, Inc. | 2024-11-18 |
| ProFound Detection (V4.0) | Icad, Inc. | 2024-11-08 |
| Lunit INSIGHT DBT v1.1 | Lunit, Inc. | 2024-10-04 |
| See-Mode Augmented Reporting Tool, Thyroid (SMART-T) | See-Mode Technologies Pte, Ltd. | 2024-09-09 |
| MammoScreen® (3) | Therapixel | 2024-08-01 |
| Lunit INSIGHT DBT | Lunit, Inc. | 2023-11-06 |
| Genius AI Detection 2.0 with CC-MLO Correlation | Hologic, Inc. | 2023-05-23 |
| Genius AI Detection 2.0 | Hologic, Inc. | 2022-10-06 |
| Transpara 1.7.2 | Screenpoint Medical B.V. | 2022-08-03 |
| ProstatID | Scanmed, LLC | 2022-07-08 |
| Saige-Dx | DeepHealth, Inc. | 2022-05-12 |
| BU-CAD | Taihao Medical, Inc. | 2021-12-21 |
| MammoScreen 2.0 | Therapixel | 2021-11-26 |
| Lunit INSIGHT MMG | Lunit, Inc. | 2021-11-17 |
| Transpara 1.7.0 | Screenpoint Medical B.V. | 2021-06-02 |
| ProFound AI Software V3.0 | Icad, Inc. | 2021-03-12 |
| Genius AI Detection | Hologic, Inc. | 2020-11-18 |
| MammoScreen | Therapixel | 2020-03-25 |
| Transpara | Screenpoint Medical B.V. | 2020-03-05 |
| Transpara | Screenpoint Medical B.V. | 2019-12-10 |
| ProFound AI Software V2.1 | Icad, Inc. | 2019-10-04 |
| PowerLook Tomo Detection V2 Software | Icad, Inc. | 2018-12-06 |
| Transpara | Screenpoint Medical B.V. | 2018-11-21 |
Facts only, sourced per entry. Listing is not evaluation. Full methodology on the registry index. Evaluating this category? The due-diligence checklist and free instruments are where buyers start.