Use of AI in imaging paves the way for other medical devices

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Boston Business Journal

July 31, 2025

AI

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The FDA approved the first AI-enabled medical device in 1995 for radiology. Three decades later, AI is expanding beyond hospital imaging into technologies that can diagnose neurological conditions using little more than a smartphone.

While artificial intelligence looks significantly different today than it did 30 years ago, radiology remains its strongest foothold in medical devices, since there are decades of labeled images with which to train AI models.

But that foundation is now enabling AI to branch into new areas. Across the board, AI works best when it has access to high-quality, clean, well-labeled data. The better the data, the faster and easier AI can help achieve tasks, from combing through Excel sheets to identifying specific types of cancer.

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