Table 1 A list of oncology-related AI technologies with FDA approval
From: Novel research and future prospects of artificial intelligence in cancer diagnosis and treatment
Device name | Year | Company | Task | Type | Clinical applications | FDA summary |
|---|---|---|---|---|---|---|
Quantib Prostate | 2022 | Quantib BV | Offers features for reading prostate MRI in one workflow | Supervised machine learning algorithms | Retrospective analysis of 108 patients’ prostate mpMRI tests [28] was done | K221106.pdf (fda.gov) |
EFAI RTSuite CT HN-Segmentation System | 2022 | Ever Fortune.AI Co., Ltd | Uses noncontrast CT scans, and reveals the first outlines of the organs that are at risk in the head and neck area | DL | The intended users are radiation oncology professionals, including but not limited to, radiation oncologists, medical physicists, and dosimetrists | K220264.pdf (fda.gov) |
Precise Image | 2022 | Philips Medical Systems Nederland, B.V | Uses computer reconstruction to create images of the head and body using X-ray transmission data collected at various angles and planes | DL | Head, body, vascular, and cardiac | K210760.pdf (fda.gov) |
Paige Prostate | 2021 | Paige.AI | Assists the pathologist in the diagnosis of prostate cancer | DL | A cohort of 105 prostate core needle biopsies (CNBs) was evaluated through digital pathology [29] | DEN200080.pdf (fda.gov) |
Oncospace | 2021 | Oncospace, Inc. | Supports radiation oncologists and medical dosimetrists during radiotherapy treatment planning for prostate, thoracic, pancreas, and head & neck cases | ML | Oncospace has provided clinical performance testing results with a library comprising a clinical dataset to demonstrate safety or effectiveness | K202284.pdf (fda.gov) |
VBrain | 2021 | Vysioneer Inc. | Assists in brain tumor contouring | DL | 100 randomly selected patients with unresected brain metastases treated with SRS at an institution [30] from 2017 to 2020 | K213628.pdf (fda.gov) |
GI Genius | 2021 | Cosmo Artificial Intelligence—AI Ltd | Aids endoscopists in detecting colonic mucosal lesions | DL | COLO-DETECT was the first multicenter randomized controlled trial evaluating GI Genius™ in real-world colonoscopy practice [31] | K211951.pdf (fda.gov) |
EndoScreener | 2021 | Chengdu Wision Medical Device Co., LTD | Automatically detects polyps | DL | A prospective, multicenter, single-blind randomized tandem colonoscopy study of 196 patients[32] | K211326.pdf (fda.gov) |
NinesMeasure | 2021 | Nines, Inc. | Measures the size of selected pulmonary nodules in a radiological image | ML | The device is intended to be used as a measurement tool by a trained radiologist and is limited to analysis of imaging data | K202990.pdf (fda.gov) |
MammoScreen | 2020 | Therapixel | Identifies breast soft tissue lesions or calcifications | ML | A cross-sectional study of 448 invited participants demonstrated its effectiveness [33] | K211541.pdf (fda.gov) |
PROView | 2020 | GE Medical Systems SCS | Provides an automatic segmentation of the prostate on MRI T2-weighted acquisitions | DL | It is a tool that aids clinicians in reviewing multiparametric prostate magnetic resonance (MR) images following PI-RADS guidelines | K193306.pdf (fda.gov) |
AI-Rad Companion (Pulmonary) | 2019 | Siemens Medical Solutions USA, Inc. | Supports quantitative and qualitative analysis of previously acquired CT DICOM images | DL | 499 radiographs were retrospectively included to evaluate the performance of the AI-Rad [34] | K183271.pdf (fda.gov) |
ProFound AI Software V2.1 | 2019 | ICAD Inc. | Detects malignant soft tissue densities and calcifications in digital breast tomosynthesis (DBT) images | DL | The detections and “certainty of finding” and case scores assist interpreting physicians in identifying soft tissue densities and calcifications | K191994.pdf (fda.gov) |
QuantX | 2017 | Quantitative Insights, Inc. | Registers images and has automated segmentation and analysis functions | ML | Provides features to aid radiologists in the visualization and analysis of breast MR images | K170195.pdf (fda.gov) |