Adopting Generative AI in Medtech

Given the vast amounts of data available, including raw measurements, diagnostic information, treatment plans, and regulatory guidelines, the biomedical technologies sector stands to gain immensely from artificial intelligence (AI), particularly machine learning (ML).

ML, at its core, learns from training datasets to identify patterns, which can then be applied to new input data to make direct inferences. For instance, if specific body scans frequently result in a particular diagnosis, ML can be used to quickly provide that diagnosis when similar scans are encountered, thus aiding in disease diagnosis.

Read the full article by Duane Morris partner Agatha H. Liu, PhD on the MD+DI website

Promoting AI Use in Developing Medical Devices

The U.S. Food and Drug Administration (FDA) has issued a draft guidance intended to promote the development of safe and effective medical devices that use a type of artificial intelligence (AI) known as machine learning (ML). The draft guidance further develops FDA’s least burdensome regulatory approach for AI/ML-enabled device software functions (ML-DSFs), which aims to increase the pace of innovation while maintaining safety and effectiveness.

Read the full Alert on the Duane Morris website.

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The opinions expressed on this blog are those of the author and are not to be construed as legal advice.

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