Barostim holds official premarket approval from the United States Food and Drug Administration (FDA). It earned the distinction of being the first medical device utilizing neuromodulation approved by the FDA to treat specific heart failure patients with reduced ejection fraction who remain symptomatic despite standard guideline-directed medical therapy. Over subsequent years, the regulatory body has also cleared expanded labeling and device enhancements, validating its safety profile and clinical efficacy for broader heart failure populations through rigorous evaluation pathways.