TABLE 4.
FDA approved AI/ML based medical technologies/software.
| Device name | Parent company name | Description | FDA approval number | Type of FDA approval | Date |
| Atrial fibrillation history feature | Apple Inc. | Detection of atrial fibrillation | K213971 | 510(k) premarket notification | 03/06/2022 |
| LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System | Medtronic, Inc. | Arrhythmia detector and alarm (including ST-segment measurement and alarm) | K210484 | 510(k) premarket notification | 11/06/2021 |
| Gili Pro Biosensor (Also Known as Gili Biosensor System) | Continuse Biometrics Ltd. | Hardware and software for optical camera-based measurement of pulse rate, heart rate, breathing rate, and/or respiratory rat | DEN200038 | De novo pathway | 01/04/2021 |
| Analytic for Hemodynamic Instability (AHI) | Fifth Eye Inc. | Adjunctive hemodynamic indicator with decision point | DEN200022 | De novo pathway | 01/03/2021 |
| ECG 2.0 App | Apple Inc. | Ambulatory ECG rhythm assessment | K201525 | 510(k) premarket notification | 08/10/2020 |
| Bodyguard Remote Monitoring System | Preventice Technologies, Inc. | Arrhythmia detector and alarm (Including ST-segment measurement and alarm) | K192732 | 510(k) premarket notification | 26/03/2020 |
| AI-ECG Tracker | Shenzhen Carewell Electronics Co., Ltd | Assessment of arrhythmias using ECG data acquired from adults without pacemakers | K200036 | 510(k) premarket notification | 20/03/2020 |
| Eko Analysis Software | Eko Devices Inc. | Support in the evaluation of patients’ heart sounds and ECG’s | K192004 | 510(k) premarket notification | 15/01/2020 |
| FFRangio | CathWorks Ltd. | Analysis of previously acquired angiography DICOM data for patients with coronary artery disease | K192442 | 510(k) premarket notification | 09/12/2019 |
| EchoGo Core | Ultromics Ltd. | Quantification and reporting of results of cardiovascular function | K191171 | 510(k) premarket notification | 13/11/2019 |
| AI-Rad Companion (Cardiovascular) | Siemens Medical Solutions USA, Inc. | Image processing software for analysis from CT images to support physicians in evaluation and assessment of cardiovascular diseases | K183268 | 510(k) premarket notification | 10/09/2019 |
| EMurmur ID | CSD Labs GmbH | Detection and identification of heart murmurs | K181988 | 510(Kk) premarket notification | 17/04/2019 |
| KardiaAI | AliveCor, Inc. | Ambulatory ECG rhythm assessment | K181823 | 510(k) premarket notification | 11/03/2019 |
| EchoMD Automated Ejection Fraction Software | Bay Labs, Inc. | Provides automated estimation of left ventricular ejection faction based on acquired transthoracic cardiac ultrasound images | K173780 | 510(k) premarket notification | 14/06/2018 |
| Acumen Hypotension Prediction Index (HPI) Feature Software | Edwards Lifesciences LLC | Detection support for future hypotensive events | DEN160044 | De novo | 16/03/2018 |
| Arterys Cardio DL | Arterys Inc. | Analysis of cardiovascular images acquired from MR scanners | K163253 | 510(k) premarket notification | 05/01/2017 |
| Steth IO | Stratoscientific, Inc. | Detection and amplification of sounds from the heart and lungs | K160016 | 15/07/2016 |
ECG, electrocardiogram; CT, computed tomography; MR, magnetic resonance.