FDA Clears FUJIFILM Healthcare’s Endoscopic Ultrasound Scope

FUJIFILM Healthcare Americas Corporation has received U.S. Food and Drug Admninistration 510(k) clearance for the new EG-740UT¹ linear endoscopic ultrasound (EUS) scope, which is compatible with the Fujifilm ARIETTA 850² ultrasound processor. The ARIETTA 850 is the longstanding go-to ultrasound processor for EUS procedures that became part of the Fujifilm product portfolio in March 2021 upon completion of the Hitachi business transfer.

“The introduction of the EG-740UT and its compatibility with the ARIETTA 850 is truly the next step in advancing therapeutic EUS for our customers,” said Taisuke Fujita, general manager of endoscopy at FUJIFILM Healthcare Americas Corporation. “This all-Fujifilm solution delivers high-end, all-around clinical performance, and we’re proud to bring therapeutic endoscopists this vital technology to manage the patient care pathway from diagnosis to treatment across care settings.”
 
As part of Fujifilm’s next-generation 700 Series portfolio, the EG-740UT is the company’s premium EUS scope designed for both diagnostic and therapeutic endoscopic ultrasound procedures in the upper digestive tract (esophagus, stomach, and duodenum). Coupled with the ARIETTA 850 ultrasound processor, Fujifilm offers³ a full complement of EUS solutions suitable for the complex clinical needs of large academic medical centers and in addition to ambulatory surgical centers and community hospitals.

The EG-740UT features a high-performance transducer that adjusts piezoelectric direction and enables high ultrasonic conversion efficiency, allowing the ultrasound to pick up small signals from the target tissue. The scope’s distal end has been reconfigured with changes made to the positioning of the camera lens, transducer and instrument channel outlet which result in increased visibility of treatment devices. The scope is also equipped with Fujifilm’s “G-LOCK” mechanism, which can fixate the guidewire during intra procedural instrument exchange, which may reduce the complexity and duration of instrument exchanges.
 
The EG-740UT enables the performance of a greater variety of therapeutic techniques—including double guidewire techniques—as its larger 4mm working channel decreases the resistance for larger caliber stents designed for endoscopic ultrasound-guided transluminal drainage. In addition, the scope is equipped with the features and benefits of Fujifilm’s 700 Series portfolio, including the company’s one-step connector—which eliminates the need to attach a separate video connector—and compatibility with advanced visualization modes including Blue Light Imaging and Linked Color Imaging. Together these features help to streamline procedures and reduce the need to exchange for a second, diagnostic scope mid-procedure, allowing for the EG-740UT to be used for both diagnostic and therapeutic purposes.
 
The ARIETTA 850 ultrasound processor for EUS procedure is equipped with Fujifilm’s ultrasonic transmission and reception technology “eFocusing” and image processing technology “Carving Imaging” making it possible to render clear ultrasound images for visualization and tissue acquisition in the target organ. In addition, the ARIETTA 850 is equipped with various diagnostic applications such as “Real-time Tissue Elastography (RTE),” which uses color to express variations in tissue elasticity, and “Shear Wave Measurement,”⁴ which can quantitatively evaluate the elasticity of the tissue. These additional diagnostic tools provide physicians the ability to locate, target, and obtain accurate and precise tissue samples from the intended organ, enabling them to streamline care and shape treatment plans.  
 
“We evaluated Fujifilm’s ARIETTA 850 ultrasound processor with their linear and radial EUS scopes at Brigham and Women’s Hospital and immediately appreciated the image quality and scope performance enabled by this combination of cutting-edge technologies,” said Christopher Thompson, M.D., director of endoscopy, co-director, Center for Weight Management and Wellness, Brigham and Women’s Hospital, professor of medicine, Harvard Medical School. “Fujifilm is innovating in the EUS space, and we’re excited to bring these technologies into our daily practice.” 
 
With the addition of the EG-740UT, Fujifilm now offers three EUS scopes (EG-580UT Curved Linear and EG-580UR Radial), which are compatible with the company’s two ultrasound processors: the legacy SU-1 Platinum processor as well as the ARIETTA 850. 
 
FUJIFILM Healthcare Americas Corporation has a range of technology and expertise in detecting, diagnosing, and treating diseases. Fujifilm’s medical imaging portfolio includes solutions for digital radiography, mammography, computed tomography, MRI, ultrasound, gastroenterology, pulmonology, endosurgery, and minimally invasive surgery. The Synapse Enterprise Imaging portfolio provides healthcare professionals with the cross-departmental imaging and data access needed to deliver a complete patient record. Fujifilm’s AI initiative, REiLI, combines Fujifilm’s rich image-processing heritage with cutting-edge AI innovations to inspire clinical confidence and combat burnout. The In-Vitro Diagnostic portfolio provides molecular based immunoassay technology for liver surveillance, clinical diagnostic chemicals for laboratories and diagnostic chemicals for OEM white labeling products. The company is headquartered in Lexington, Mass. 
 
FUJIFILM Holdings Corporation, Tokyo, develops products and services in healthcare, materials, business innovation, and imaging. For the year ended March 31, 2022, the company earned roughly 2.5 trillion yen ($21 billion) in revenue. 

References 
¹ The EG-740UT is designed and manufactured by FUJIFILM Corporation
² The ARIETTA 850 is designed and manufactured by FUJIFILM Healthcare Corporation.
³ The EG-740UT and the compatible ARIETTA 850 will be commercially available in the U.S. in early 2023.  
⁴ Shear Wave Measurement is compatible with the EG-740UT EUS scope.