Visura Technologies Receives FDA Clearance for the TEE Camera Assist Device System

Technologies, a start-up medical device company based in Evanston,
IL, has received 510(k) clearance from the US Food and Drug
Administration (FDA) for its TEE Camera Assist Device (TEECAD) System.
TEECAD’s single-use disposable camera easily attaches to a
transesophageal echocardiogram (TEE) ultrasound probe allowing
physicians to view the upper airway and esophagus during probe placement
for safe intubation.

TEE is a common cardiovascular procedure, performed more than 500,000
times annually in the US, in which an ultrasound probe is placed in the
patient’s esophagus to capture high-resolution ultrasound images of the
heart valves and atria. Physicians currently place TEE probes blindly,
guided by physician feel and patient cooperation, potentially resulting
in failed intubations that can lead to cancelled therapeutic procedures
and major complications such as esophageal or pharyngeal perforation.

Visura Founder Dr. David Marmor, a noninvasive cardiologist and
experienced TEE operator, commented, “TEE related complications and
failed intubations can be dangerous for patients and have costly
ramifications for hospitals. The recent proliferation of catheter-based
structural heart interventions reliant on TEE imaging has led 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. We look forward to clinically introducing our device.”

The TEECAD System consists of a single-use disposable camera Carrier
that removably attaches to the TEE probe, and a separate Viewing System
display that allows the physician to view real-time images from the
camera to visually assist with safe probe intubation. The clearance of
Visura’s first TEECAD camera Carrier is for use with the Philips X7-2t
probe. The company plans to develop additional Carrier models compatible
with other TEE probes available in the market.

Established in 2015, Visura Technologies is a medical device company
dedicated to improving the safety and success of transesophageal
echocardiography procedures.

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