Table 2.
Row Labels | Anesthesiology | Cardiovascular | Clinical Chemistry | Neurology | Grand Total |
---|---|---|---|---|---|
(Figure 1 criteria missing) | |||||
Asthma or COPD management | 1 (3) | 0 | 0 | 0 | 1 |
Diabetes management | 0 | 0 | 2 (3) | 0 | 2 |
ECG based arrhythmia detection | 0 | 1 (1) | 0 | 0 | 1 |
EEG based detection | 0 | 0 | 0 | 1 | 1 |
Hemodynamics & VS monitoring | 0 | 8 (2 or 3) | 0 | 0 | 7 |
Sleep monitoring | 2 (3) | 0 | 0 | 0 | 2 |
Grand Total | 3 | 9 | 2 | 1 | 15 |
There was only 1 implantable solution for ECG recording, and it was also equipped with a classification algorithm for automatic arrhythmia detection. Approximately 38% of solutions were compatible with apps. None of AI RPM was classified as a life-sustaining solution. The clinical efficacy evidence of the solutions is compiled in the second part of the Supplemental Information section of this paper. We also explained Denovo approvals as case studies for readers to understand the level of performance, evidence, and process for innovative solutions in the third part of the Supplemental Information section of this paper.