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Samsung gets FDA 510(k) clearance for new ultrasound system

MDBR Staff Writer Published 26 March 2018

Samsung Electronics subsidiary Samsung NeuroLogica has secured 510(k) clearance from the US Food and Drug Administration for its new RS85A ultrasound system.

The company has unveiled the new ultrasound system at the American Institute of Ultrasound in Medicine (AIUM) event in New York City, US.

Samsung RS85A system features an improved MV-Flow solution that helps to visualize slow-flow micro vascularized structures, which is hard to evaluate with conventional power Doppler ultrasound.

The MV-Flow solution will also enable clinicians to check lesions for indications of cancer or inflammation.

The system also features an S-Shearwave Imaging capability, which offers new indicators for clinical diagnosis by measuring the elasticity of tissue or lesions through shearwave elastography. It will help to carry out the effective diagnosis for breast and liver diseases.

Samsung RS85A also has CEUS+, which will use a contrast agent in adult and pediatric populations to diagnose and characterize lesions in the liver.

In addition, the system’s S-Fusion allows using real-time ultrasound in conjunction with other volumetric imaging modalities such as an MRI or a CT for simultaneous localization of a lesion.

According to the company, the RS85A system has been developed to help decrease user-fatigue and repetitive motions with an enhanced monitor arm and increased range of motion and tilt.

The enhancements will support the user to position the monitor for optimal viewing and control. The system also combines multi-step actions into a single step to help reduce keystrokes and repetitive user interface interactions.

Samsung NeuroLogica president and CEO Philip Sullivan said: “We are pleased to launch the RS85A, a new premium general imaging ultrasound system with superior image quality and usability based on Samsung’s advanced ultrasound and radiology technologies.

“The RS85A embodies Samsung’s commitment to providing leading technologies to healthcare providers by combining our key values of access, accuracy and efficiency.”

Samsung NeuroLogica is engaged in the developing, manufacturing and marketing of advanced imaging technologies for the customers.


Image: The RS85A S-Shearwave Imaging provides new indicators for clinical diagnosis by quantifying the elasticity of tissue or lesions via shearwave elastography. Photo: courtesy of Business Wire.