3 Key Considerations for Promoting Transparency for AI/ML-Enabled Medical Devices

Today, developers of innovative medical devices are increasingly utilizing artificial intelligence (AI) and machine ...

Public Health Crises and FDA Scrutiny

Every public health emergency or outbreak brings with it a corresponding urgent need for ...

The FDA, Marketing Claims, and Digital Health Products

For both developers and marketers of digital health products, a thorough evaluation of each ...

The Reality of Connected Medical Devices

Every healthcare facility has been quickly adding large numbers of connected medical devices to ...

Marketing Laboratory Developed Tests

On April 4, 2019, the U.S. Food and Drug Administration issued a Warning Letter ...