ImaCor, a developer of hemodynamic transesophageal echocardiography (HTEE) monitoring solutions, has received CE mark approval for its Clari TEE probe and Zura platform.
The ClariTEE is a miniaturized TEE probe which is designed for hemodynamic assessment of high-acuity patients who remain indwelling for up to 72 hours.
ClariTEE and Zura have also received the US Food and Drug Administration (FDA) 510(k) clearance.
ImaCor co-founder and CMO Scott Roth said they welcome this opportunity to work with European clinicians who have already expressed substantial interest in using HTEE, the first technology that allows continuous availability of TEE in intensive care units.
"Given the high level of ultrasound integration in European critical care, I expect HTEE to make a rapid and significant impact,"Roth said.