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.
The Reading Room Podcast: Current Perspectives on the Updated Appropriate Use Criteria for Brain PET
March 18th 2025In a new podcast, Satoshi Minoshima, M.D., Ph.D., and James Williams, Ph.D., share their insights on the recently updated appropriate use criteria for amyloid PET and tau PET in patients with mild cognitive impairment.
Meta-Analysis Shows Merits of AI with CTA Detection of Coronary Artery Stenosis and Calcified Plaque
April 16th 2025Artificial intelligence demonstrated higher AUC, sensitivity, and specificity than radiologists for detecting coronary artery stenosis > 50 percent on computed tomography angiography (CTA), according to a new 17-study meta-analysis.
New bpMRI Study Suggests AI Offers Comparable Results to Radiologists for PCa Detection
April 15th 2025Demonstrating no significant difference with radiologist detection of clinically significant prostate cancer (csPCa), a biparametric MRI-based AI model provided an 88.4 percent sensitivity rate in a recent study.
