FDA clears ImaCor mini TEE probe

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ImaCor has received FDA 510(k) clearance to market the ClariTEE probe, a miniaturized transesophageal echocardiography (TEE) probe, which facilitates episodic monitoring of cardiac function, and the Zura imaging system.

The Uniondale, N.Y.-based ImaCor said its ClariTEE is a single-use device that can remain indwelling for up to 72 hours, allowing intensivists and anesthesiologists to periodically assess cardiac preload and left ventricular systolic function over a prolonged period of time.

“The ClariTEE probe is minimally invasive and allows physicians to directly visualize cardiac size and function, and to assess changes as pharmacologic interventions are made,” said Scott L. Roth, MD, CEO and a founder of ImaCor.