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FDA clears 3-D EchoTech add-on
The Food and Drug Administration has granted 510(k) marketing clearance to 3-D EchoTech for the German company's 3-D FreeScan module, which enables conventional ultrasound scanners to create 3-D images. The Munich-based company plans to begin selling
The Food and Drug Administration has granted 510(k) marketing clearance to 3-D EchoTech for the German company's 3-D FreeScan module, which enables conventional ultrasound scanners to create 3-D images. The Munich-based company plans to begin selling the device immediately via direct sales and through OEMs, with a list price of around $19,500, not including computer.
The 3-D FreeScan module consists of an electromedical sensor that attaches to a standard ultrasound probe. It enables sonographers to use freehand scanning methods to collect 3-D data, rather than stepping motors or other mechanical devices. Three-D images are processed and reconstructed on Pentium-class PCs in about 40 seconds. Once reconstructed, the images can be manipulated and rotated in real time, according to Ricardo Cabrera, director of sales and marketing for the Americas region.
The FDA clearance covers radiology applications of 3-D FreeScan, as well as neurology, peripheral vascular, and urology applications. The company is preparing a 510(k) application for a version of the technique that uses an ECG trigger to collect cardiac images. It displayed the technique at the American Society of Echocardiography in San Francisco this month.
New Study Assesses Long-Term Outcomes of PSMA PET Use in PCa Recurrence Cases
October 24th 2024For patients with biochemical recurrence of prostate cancer, PSMA PET imaging may facilitate a 12.8 percent lower incidence of prostate cancer mortality in contrast to the combination of CT and bone scan, according to long-term outcome estimates from a new decision-analytic modeling study.
Can Diffusion MRI Predict Patient Response to Neoadjuvant Chemotherapy for Breast Cancer?
October 23rd 2024A model emphasizing time-dependent diffusion MRI was 15 percent more effective than apparent diffusion coefficient (ADC) measurements at predicting pathologic complete response to neoadjuvant chemotherapy for women with breast cancer, according to new research.
