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The FDA is finalizing guidance that urges sponsors to minimize device design changes in generic drug delivery products, and outlines how differences could threaten substitutability. Read More
The company said the approval “forms the basis of the additional regulatory approval it will seek through the World Health Organization prequalification program.” Read More
The company has plans to train the device’s software to detect a range of health-related complications, including traumatic brain injury and brain tumors. Read More
The technology “highlights a vast array of medical findings to help radiologists prioritize readings,” the artificial intelligence startup said. Read More