Table 1.
List of 22 unique AI/ML-enabled, FDA-approved technologies indicated for diagnosis and/or management of stroke. Twenty technologies are indicated for stroke diagnosis and two for post-stroke rehabilitation, with approval dates ranging from February 2018 to April 2021. Eighteen companies developed these technologies, with 11/18 (61%) headquartered outside the United States. Generally, the technologies indicated for stroke diagnosis utilize convolutional neural networks as their underlying algorithm. CTA: Computed Tomography Angiography; CTP: Computed Tomography Perfusion; ICH: Intracranial Hemorrhage; LVO: Large Vessel Occlusion. * RAPID is indicated for both LVO and CTP analysis. ** CINA is indicated for both LVO and ICH analyses. 510(k) refers to a premarket submission made to the FDA demonstrating the proposed device to be as safe and effective as a legally marketed device. 513(f)(2) (De Novo) classification describes devices that are considered for Class I (low-to-moderate risk) or II (moderate-to-high risk) categorization, either after receiving a “not substantially equivalent” determination post-510(k) submission or in cases where there is no legally marketed device to determine substantial equivalence. A breakthrough status designation aims to expedite the development, assessment, and review of a medical device to provide patients with timely access to such a device while maintaining FDA statutory standards in the approval process.
| Device | Company Name | Headquarters | FDA Approval Number | Type of Approval | Indication | Date of Approval |
|---|---|---|---|---|---|---|
| ContaCT (Viz LVO) | Viz.ai | San Francisco, CA, USA | DEN170073 | 513(f)(2)(De Novo) | Analyze acute CTA to identify LVO | February 2018 |
| Viz CTP | Viz.ai | San Francisco, CA, USA | K180161 | 510(k) | Analyze brain tissue perfusion parameters on CTP | April 2018 |
| BriefCase | Aidoc Medical | Israel | K180647 | 510(k) | ICH detection in non-contrast CT | August 2018 |
| Accipiolx | MaxQ Al | Israel | K182177 | 510(k) | ICH detection in non-contrast CT | October 2018 |
| Vitrea CT Brain Perfusion | Vital Images | Minnetonka, MN, USA | K181247 | 510(k) | Visualize apparent blood perfusion in brain tissue affected by acute stroke on CT | November 2018 |
| RAPID * | iSchemaView | Golden, CO, USA | K182130 | 510(k) | Identification of CTP, CTA, and MRI images consistent with stroke | December 2018 |
| HealthICH | Zebra Medical Vision (now Nanox AI) | Israel | K190424 | 510(k) | Aid clinical assessment of non-contrast head CT with features suggestive of ICH | June 2019 |
| DeepCT | Deep01 Limited | Taiwan | K182875 | 510(k) | ICH detection in non-contrast CT | July 2019 |
| Icobrain-CTP | Icometrix | Belgium | K192962 | 510(k) | Image analysis of brain CT perfusion scans | February 2020 |
| Rapid ICH | iSchemaView | Golden, CO, USA | K193087 | 510(k) | ICH detection in non-contrast CT | March 2020 |
| CuraRad-ICH | CuraCloud | Seattle, WA, USA | K192167 | 510(k) | ICH detection in non-contrast CT | April 2020 |
| NinesAI | Nines | Palo Alto, VA, USA | K193351 | 510(k) | ICH detection in non-contrast CT | April 2020 |
| CINA ** | AVICENNA.AI | France | K200855 | 510(k) | ICH in head CT and LVO in head CT angiography | June 2020 |
| Rapid ASPECTS | iSchemaView | Golden, CO, USA | K200760 | 510(k) | ASPECT scoring in patients with known MCA or ICA occlusions | June 2020 |
| QER | Qure.Ai Technologies | India | K200921 | 510(k) | ICH detection in non-contrast CT | June 2020 |
| Augmented Vascular Analysis | See-Mode Technologies | Singapore | K201369 | 510(k) | Predict stroke risk from vascular ultrasound | September 2020 |
| HALO | NICo-Lab B.V. | Amsterdam | K200873 | 510(k) | LVO identification in anterior circulation (ICA, M1 or M2) from CT angiogram | November 2020 |
| FastStroke, CT Perfusion 4D | GE Medical Systems SCS | France | K193289 | 510(k) | CT Perfusion 4D: Perfusion abnormalities from contrast CTFastStroke: Stroke detection from CT (e.g., non-constast, angiogram) | November 2020 |
| Neuro.Al Algorithm | TeraRecon | Durham, NC, USA | K200750 | 510(k) | Detect changes in brain perfusion from CT or MRI | November 2020 |
| BrainQ | BrainQ | Israel | - | Breakthrough status | Reduce disability post-stroke | February 2021 |
| Viz ICH | Viz.ai | San Francisco, CA, USA | K210209 | 510(k) | Analyze acute non-contrast CT of brain, notify specialist of suspected ICH | March 2021 |
| IpsiHand Upper Extremity Rehabilitation System | Neurolutions | Santa Cruz, CA, USA | - | Breakthrough status | Post-stroke rehabilitation | April 2021 |