News|Articles|October 24, 2025
FDA Grants Fast Track Designation to Emerging Ultrasound Contrast Agent
Author(s)Jeff Hall
Designed for use in saline contrast echocardiography, the ASI-02 modality is currently being evaluated in a multicenter, randomized trial for patients undergoing transthoracic echocardiography (TTE).
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The Food and Drug Administration (FDA) has issued a fast track designation for the ultrasound contrast agent ASI-02, which may enhance visualization and efficiency for transthoracic echocardiography (TTE).
While the current standard of care for an agitated saline contrast echocardiogram involves manual agitation of saline and air to create injectable microbubbles for visualization of blood flow, the
The company noted that ASI-02 is currently being compared with standard agitated saline in a multicenter randomized trial involving 300 patients undergoing TTE.
“By earning fast track designation, we are one step closer to providing a right-heart diagnostic tool designed to simplify the sonographer’s workflow and enhance diagnostic accuracy for cardiologists and patients,” noted Morgan Evans, the co-founder and CEO of Agitated Solutions.
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