FDA loosens data rules for medical devices by allowing real-world evidence without patient identifiers in marketing submissions.

The FDA now accepts RWE for device submissions without needing identifiable patient data, facilitating the use of large, de-identified databases. This change addresses previous limitations that ...

The FDA said it plans to accept new forms of real-world evidence in product applications, starting with a subset of medical ...

Healthcare systems worldwide are facing unprecedented pressure, from the rise in chronic diseases and aging populations to fragmented healthcare and over-stretched resources. The result? Delayed, ...

Synthetic control arms may help tackle the unique complexities, but key challenges such as data access and standardisation ...

Pharma and biotech companies have access to an unprecedented variety of health data, from electronic health records and ...

Mayo Clinic clinicians are starting to explore how they might use healthcare-specific large language models – accessed through a generative artificial intelligence chat application – to enhance ...

In the evolving landscape of artificial intelligence (AI), the assumption that more data lead to better models has driven unchecked reliance on synthetic data to augment training datasets. Although ...

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This is read by an automated voice. Please report any issues or inconsistencies here. In an Indian town, workers fold towels while wearing cameras, providing data to teach AI robots how to move and ...

Imagine a world where every business decision is powered by real-time AI insights, where synthetic data eliminates privacy concerns, and where your personal data becomes as valuable as currency.