Search Tag: device safety

2025 02 Sep

  Artificial intelligence–enabled medical devices are now a routine feature in clinical practice across the United States. Cleared almost exclusively through the Food and Drug Administration’s 510(k) pathway, these products do not require prospective human testing before approval. As a result, many are introduced to the market with little or no...Read more

2025 02 Sep

  Artificial intelligence–enabled medical devices are now a routine feature in clinical practice across the United States. Cleared almost exclusively through the Food and Drug Administration’s 510(k) pathway, these products do not require prospective human testing before approval. As a result, many are introduced to the market with little or no...Read more