Pitfalls - Dinesh Puppala

Regulatory Affairs, SaMD & Digital Health Expert

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The Impact of Generative AI on Healthcare: Promises and Pitfalls

on January 21, 2024January 21, 2024

The Impact of Generative AI on Healthcare: Promises and Pitfalls Artificial intelligence has been making significant strides in various industries, and healthcare is no exception. Generative AI, in particular, has the potential to revolutionize the way healthcare is delivered, making diagnosis and treatment more efficient and effective. However, like any other technology, generative AI also …

Common Pitfalls to Avoid in FDA 510(k) Submission for Medical Device Approval

on January 19, 2024January 19, 2024

Common Pitfalls to Avoid in FDA 510(k) Submission for Medical Device Approval The FDA 510(k) submission is a crucial step in the approval process for medical devices. It is a premarket submission made to demonstrate that the medical device to be marketed is at least as safe and effective as, and substantially equivalent to, a …