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ImaCor’s Disposable Transesophageal Echocardiography Probe and System Get FDA OK

July 31st, 2008 Medgadget Editors Anesthesiology, Cardiology, Critical Care, Medicine


Have you ever heard of a disposable TEE? The piezoelectric elements in ultrasounds are known not to be cheap. Hence we were quite surprised to learn about this newly approved product from ImaCor of Uniondale, New York, a single use (up to 72 hours) miniaturized transesophageal echocardiography probe and imaging system.
From the press release:

ImaCor announces that it has received 510(k) clearance from the U.S. Food and Drug Administration to market the ClariTEE™ probe and the ZuraTM imaging system. The ClariTEE probe is a miniaturized transesophageal echocardiography probe which facilitates episodic monitoring of cardiac function. The 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.
“ImaCor believes that the ClariTEE probe will be a major contribution to the care of the critically ill, especially in ICU and perioperative situations” said Scott L. Roth, MD, Chief Executive Officer and a founder of ImaCor. “Current methods of monitoring hemodynamics in this patient population are either invasive, inconclusive, or both. 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,” adds Roth.

"This is a technology that intensive care physicians have been waiting for,” says Dr. Alexander Levitov, Critical Care section chief at Carilion Roanoke Memorial Hospital in Virginia. Levitov adds, “The ClariTEE probe has the potential to become the standard of care in managing hemodynamically unstable patients in the ICU.”

We contacted ImaCor to inquire about the pricing of the device, but no one at the firm was available to comment.
Press release: ImaCor receives 510(k) clearance of its ClariTEE probe and Zura Imaging System (.pdf)…
Product page: ClariTEE Probe and Zura Imaging System…

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Medical technologies transform the world! Join us and see the progress in real time. At Medgadget, we report the latest technology news, interview leaders in the field, and file dispatches from medical events around the world since 2004.

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