Caroline Shleifer
Caroline Shleifer
Soapbox

Unlocking Success in SaMD Product Launches Through AI

By Caroline Shleifer

AI-driven regulatory platforms support SaMD organizations by proactively monitoring and adapting to the dynamic global regulatory landscape. The technology alerts users to anticipated regulatory updates worldwide, facilitating improved foresight and trend detection. It also provides guidance on addressing potential lapses in product compliance, integrates with existing workflows and streamlines regulatory tasks from classification to registration and market entry.

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John Schwope
John Schwope
Soapbox

The Power of AI to Enhance Clinical Trials

By John Schwope

AI not only improves data collection and analysis, it impacts which products are engaged in clinical trials, determines necessary medical criteria, helps design the trials and can even choose the best participating facilities. The result is, organizations that leverage AI will be more successful and will go to market faster than those that don’t.

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FDA Logo
FDA Logo

FDA Updates Breakthrough Devices Program Guidance

By MedTech Intelligence Staff

The updated guidance clarifies how the program applies to medical devices that may address health inequities, as well as those that may increase access to care or provide a non-addictive treatment option to treat pain or addiction. It also clarifies the FDA’s current interpretation of the Breakthrough Device designation criteria.

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