Medical Innovation Exchange

FDA clearance

FDA-Cleared SaMD by the Numbers

FDA-Cleared SaMD by the Numbers     If industry buzz is any measure of actual activity, then Software as a Medical Device (SaMD) is the current darling of the MedTech world. Despite this, it’s difficult to quantify just how many SaMD have reached the market in the U.S. While the information needed to identify a medical …

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Sonio Receives FDA 510(k) Clearance For Use of AI in Prenatal Ultrasounds

Sonio Receives FDA 510(k) Clearance For Use of AI in Prenatal Ultrasounds     Sonio has received Regulatory Class II FDA 510(k) clearance for Sonio Detect, a manufacturer-agnostic software product that uses artificial intelligence (AI) to enhance the quality of fetal exams, and automatically detect views and quality criteria of ultrasound images. In clinical testing, Sonio …

Sonio Receives FDA 510(k) Clearance For Use of AI in Prenatal Ultrasounds Read More »

Sonio Receives FDA 510(k) Clearance For Use of AI in Prenatal Ultrasounds

Sonio Receives FDA 510(k) Clearance For Use of AI in Prenatal Ultrasounds     Sonio has received Regulatory Class II FDA 510(k) clearance for Sonio Detect, a manufacturer-agnostic software product that uses artificial intelligence (AI) to enhance the quality of fetal exams, and automatically detect views and quality criteria of ultrasound images. In clinical testing, Sonio …

Sonio Receives FDA 510(k) Clearance For Use of AI in Prenatal Ultrasounds Read More »