3 results
Approved WMOCompleted
To obtain the safety and effectiveness data necessary to support a Premarket Approval (PMA) Application to the U.S. Food and Drug Administration (FDA)
Approved WMOCompleted
Evaluation of the effect of positional therapy with the SPT Wave on sleep apnea severity, i.e. re-duction of the apnea-hypopnea index (AHI).
Approved WMOCompleted
To determine the efficacy and safety of the CardioFit system for the treatment of subjects with systolic heart failure who have failed to achieve symptom relief through standard evidence-based management per applicable guidelines.