Search Tag: FDA approval

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

2024 29 Jul

  Shield is first blood test approved by FDA as a primary screening option for colorectal cancer and that meets performance requirements for Medicare coverage Blood test offers easy, convenient and pleasant screening option with potential for improving colorectal cancer screening rates Guardant Health to host investor conference call...Read more