WELCOME TO VISURA
Addressing the Challenge of Blind TEE Probe Intubation
Visura Technologies has developed a novel device that provides camera visualization to improve the safety and success of transesophageal echocardiography (TEE) procedures. TEE is the gold standard for imaging heart valves and atria, however physicians currently place TEE ultrasound probes blindly resulting in failed intubations that can lead to major complications. With the recent proliferation of catheter-based structural heart interventions reliant on TEE imaging, the use of TEE for older, higher risk patients has grown significantly.
The TEECAD® camera is a single-use disposable that easily attaches to a transesophageal echocardiogram (TEE) ultrasound probe allowing physicians to view the upper airway and esophagus during probe placement for safe intubation.
THE TEECAD® SYSTEM
TEECAD® stands for the TEE Camera Assist Device. The TEECAD® System consists of two components: (1) the TEECAD® Carrier, a single-use disposable camera Carrier that removably attaches to the existing TEE probe, and (2) a separate TEECAD® Viewing System display that allows the physician to view real-time images from the camera to visually assist with safe probe intubation.
* Provides real-time visualization during TEE probe placement
* Carrier removably attaches to the TEE probe
* Carrier is soft and atraumatic adding minimal diameter to the TEE probe
* Requires no modification to existing probe or ultrasound machine
VISURA TECHNOLOGIES RECEIVES FDA CLEARANCE FOR THE TEE CAMERA ASSIST DEVICE SYSTEM [TEECAD (TM)]
July 10, 2018
Visura 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 (TM)] 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. [BusinessWire]
MEET THE VISURA TEAM
DAVID MARMOR, M.D.
Founder and Chief Medical Officer
Dave is a practicing non-invasive cardiologist in the Chicago area with expertise in cardiovascular imaging and structural heart disease. He is a high volume TEE operator.
Chief Executive Officer
Morgan holds a B.S. in biomechanical engineering from Stanford and an MBA from Kellogg. She worked in engineering, clinical, and commercialization for a neuromodulation start-up and in Corporate Development at Medtronic focused on strategy, investments, acquisitions, and divestitures.
Director of Quality
Joe has over 20 years of experience in leading quality departments in medical device, combination medical device, and pharmaceutical industries.
Director of Regulatory
Gina has 12 years of medical device regulatory experience with companies including St. Jude Medical, Autonomic Technologies, and Institute of Functional Restoration – Case Western Reserve University. She previously worked for the FDA in their Pacemaker, Defibrillator and Leads Branch.
FREQUENTLY ASKED QUESTIONS
IS THE TEECAD® DEVICE REGULATORY APPROVED FOR CLINICAL USE?
The TEECAD® System received FDA 510(k) market clearance in June 2018 for attachment to the Philips X7-2t TEE transducer probe. The company will seek international regulatory approvals beginning with CE Mark in 2019.
CAN THE TEECAD® DEVICE BE USED WITH ANY TEE ULTRASOUND PROBE?
Visura's first camera Carrier model is compatible with the commercially available Philips X7-2t TEE transducer probe. The company will be developing additional Carrier models compatible with other TEE probes.
HOW DO I ORDER THE TEECAD® DEVICE ?
The TEECAD® Viewing System and single-use camera Carriers will be available for purchase in the U.S. in late 2018. The company will provide ordering information at that time.
WILL VISURA PROVIDE USER TRAINING?
Company representatives will provide product use training for physicians and clinical staff.