FDA's Gottlieb: AI-based imaging device submissions expected to increase in coming years
FDA Commissioner Scott Gottlieb, MD, said his administration is working on an updated “new regulatory framework” to promote the use of artificial intelligence (AI) in healthcare, and he expects medical imaging to be at the forefront of AI-based healthcare devices, according to a report published by The Hill.
“We expect to see an increasing number of AI-based submissions in the coming years, starting with medical imaging devices, and we’re working with experts in the field,” he said in prepared remarks to the Health Datapalooza conference in Washington on Thursday, April 26.
Gottlieb cited a new medical device approved by the FDA this month as an example of this, according to The Hill. The technology employs AI and a special camera to help diagnose people with retinopathy.
He also said the FDA is working with experts to modernize the evaluation and approval process for these new technologies.
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