FDA Grants Fast Track Designation to Emerging Ultrasound Contrast Agent

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 ASI-02 contrast agent may provide a viable alternative for saline contrast echocardiography, according to Agitated Solutions, the developer of ASI-02.

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.