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FDA greenlights Samsung S-Vue 3.02 dose reduction solution


 

The FDA has given the green light to Samsung’s S-Vue 3.02, an image post-processing engine equipped with an advanced noise-reduction algorithm for producing high-quality images at a fraction of the radiation dose used in pediatric patients.


The solution is capable of significantly reducing X-ray dose in various imaging exams to the point where it may potentially establish safer conditions for subjecting pediatric patients in need of additional scanning to repeat exposure.


“Constantly working to lower dose exposure is a top priority for radiologists and healthcare professionals, and Samsung’s ability to offer dose reduction across its suite of DR machines represents another breakthrough in medical imaging technology,”said David Legg, vice president and head of ultrasound and digital radiography business at NeuroLogica, the healthcare subsidiary of Samsung Electronics, in a statement“This new low-dose protocol is proof that we’re continuing to reduce radiation dose in our products. We are delighted that we are now able to offer this to the patients who are most vulnerable.”


S-Vue 3.02 is incorporated on Samsung’s digital radiography systems, GC85A and GM85, and provides spatially adaptive multi-scale processing, in addition to its advanced noise-reduction capabilities.


When applied in pediatric abdomen exams, Samsung observed a dose decline of up to 45 percent, as compared to the level of its previous IPE on the same X-ray systems. It also decreased exposure by 27 percent for pediatric skull procedures, and by 15.5 percent in pediatric chest exams.


The findings support Samsung’s objective to advance as low as reasonably achievable (ALARA) standards for ensuring minimal exposure to X-ray radiation.


“Findings of our clinical trial showed that use of Samsung’s S-Vue for pediatric chest images resulted in an overall image quality that was uncompromised even at a significantly reduced radiation exposure,”said Susan John, professor and chair of diagnostic and interventional imaging at McGovern Medical School at The University of Texas Health Science Center at Houston, in a statement.“The reduction in radiation dose potentially enables repeat radiographs for better follow-up in patients from infancy into adulthood, while assisting us in confident diagnosis.”


The limited phantom and clinical study results were retrieved from the performance of routine PA chest radiography and abdominal radiography for average adults and pediatric abdominal, chest and skull radiography, excluding patients under one month old.

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