AmCad BioMed Corporation announced that it has received approval from FDA on Sep. 8th ET, for the company's 510(k) application of AmCAD-UT deep learning advanced version(K203555). The advanced AI function of AmCAD-UT is developed using a proprietary deep learning technology with a large set of clinical images. This advanced version adds a function of AI-suggested ROI contouring to assist users in analyzing the thyroid nodules. AmCAD UT is a computer aided detection (CADe) device to assist analyzing thyroid ultrasound images by providing detailed information with quantification and visualization of sonographic characteristics of thyroid nodules (including echogenic foci, echogenicity, texture, anechoic area, indistinct margin and taller-than-wide shape). With this new AI-suggested ROI contouring function, it makes the diagonstic workflow more efficient and further helps reducing unnecessary medical procedures.