GE HealthCare recently announced plans to acquire Caption Health, a company that sells AI software designed to guide cardiac imaging. The company's guidance technology aims to make ultrasound exams easier and faster, as well as allow a broader set of healthcare professionals to conduct basic echocardiography exams.
The agency published its first action plan last week for how it plans to regulate machine learning-based software as a medical device. To start, the FDA said it will issue guidance on how changes to algorithms should be regulated as they “learn.”
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Amid a growing number of devices use AI to instruct users but Caption Health says its software is the first that helps clinicians perform echocardiograms.