Catch up on a variety of FDA news in radiology from the past week.
|Articles|January 28, 2020
EDAN Instruments Reveals Upgrades to Acclarix LX9 Ultrasound System
Author(s)Whitney J. Palmer
System and upgrades awaiting U.S. FDA clearance
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DUBAI-China-based global healthcare company EDAN Instruments, Inc., unveiled its next-generation diagnostic ultrasound system Acclarix LX9 during Arab Health 2020.
The Acclarix LX9 system is currently awaiting 510(k) clearance from the U.S. Food and Drug Administration.
With Acclarix LX9, EDAN is adding artificial intelligence (AI) technologies to its existing ultrasound family. New features include eOB, eLV, eFollicle, eVolFlow, and eNT, all of which, according to Alice Bai, EDAN’s ultrasound clinical application manager, are designed to optimize workloads for sonographers in a various departments, such as obstetrics, gynecology, cardiology, and general surgery.
In addition to the additional AI features, LX9 also offers a 21.5-inch, high resolution LCD screen equipped with a new EIS+ platform that improves image quality. The integrated user interface can also be rotated 180 degrees.
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Facilitating enhanced 3D visualization of skeletal anatomy, the BoneEnhance machine learning module reportedly provides automated segmentation of bone and surrounding tissues for the Accuro XV ultrasound system.
A Kaiser score > 5 with breast MRI demonstrated a 97 percent sensitivity and 87.9 percent specificity for predicting malignancy in patients with BI-RADS 0 or 4 presentations on mammography and breast ultrasound, according to a new study.
How will generative AI software be evaluated by the FDA in the future? What’s next for point-of-care ultrasound? What steps have been successful in facilitating adoption of AI applications across enterprise systems? Leaders in radiology and health care will be discussing these topics and more at the upcoming HLTH USA conference.
Catch up on the top radiology content of the past week.
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