AI startup Harrison.ai has petitioned the US Food and Drug Administration (FDA) to exempt some new AI tools for analyzing medical images by radiologists from mandatory prenatal screening[3][5]. According to the petition, manufacturers could market such AI products without review if the FDA has previously approved the relevant product from the company, adhere to technical standards and provide a performance monitoring plan[3]. The FDA allows anyone to file such a petition to exempt devices from inspection, but this rarely happens[3]. The agency must respond to the petition within 180 days or the proposed measure will take effect by mid-April[3]. At the same time, the FDA appointed a former high-ranking executive from a subsidiary of Harrison.ai to head the department that shapes the agency's AI policy[3]. These changes follow the Trump administration's promises to deregulate AI in healthcare[1][3]. In addition, the FDA has relaxed oversight of AI-powered clinical decision software that provides a single recommendation if a physician can review its logic and data[1][2]. The expanded policy also covers consumer wearable devices for measuring physiological metrics for wellness purposes[2].