Companion Diagnostics Regulations are Evolving in Asia Personalized medicine is experiencing a global surge in popularity, with Companion Diagnostics (CDx) products playing a pivotal role in facilitating this expansion. While CDx products are being used frequently in the West for personalized medicine, in the future, providers in Asia will also use more CDx products …
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The Promise and Potential Pitfalls of AI in Medical Device Design Continuous improvements in artificial intelligence (AI) technology are transforming health care by enabling the development of increasingly precise, efficient and personalized devices. Following we look at areas where AI shows the greatest potential in health care as well as concerns that must be …
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The Promise and Potential Pitfalls of AI in Medical Device Design Continuous improvements in artificial intelligence (AI) technology are transforming health care by enabling the development of increasingly precise, efficient and personalized devices. Following we look at areas where AI shows the greatest potential in health care as well as concerns that must be …
The Promise and Potential Pitfalls of AI in Medical Device Design Read More »
FDA Issues Draft Guidance on Predetermined Change Control Plans for AI/Machine Learning-Enabled Medical Devices On March 30, the FDA’s Center for Devices and Radiological Health (CDRH) published a draft guidance, “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions.” Per the FDA’s announcement, the draft guidance …
