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Device for transesophageal echocardiogram receives FDA clearance
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Visura Technologies announced that a single-use disposable camera system used during a transesophageal echocardiogram has received 510(k) clearance from the FDA.
The device (TEECAD System, Visura Technologies) attaches to a transesophageal echocardiogram (TEE) ultrasound probe and allows physicians to see the esophagus and upper airway when placing a probe for safe intubation, according to a press release from the company. Physicians can also capture high-resolution ultrasound images of the atria and heart valves during this procedure.
“TEE-related complications and failed intubations can be dangerous for patients and have costly ramifications for hospitals,” David Marmor, MD, founder and chief medical officer of Visura, said in the press release. “The recent proliferation of catheter-based structural heart interventions reliant on TEE imaging has left to growth in procedural volume and an increase in the age and risk profile of patients, increasing the need for visual guidance for safe TEE probe intubation.”
The system features a single-use disposable camera that attaches to the probe used for transesophageal echocardiogram. A separate viewing display aids in safe probe intubation by providing real-time images from the camera, according to the press release. The camera carrier is to be used with a probe (X7-2t, Philips).
Additional camera carrier models will be developed that are compatible with other probes on the market, according to the press release.
Disclosure: Marmor is the founder of Visura.