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Machine Learning FDA Approval Clinical Trials

Knobbe Martens

FDA Clears Fasikl’s AI-Powered Felix NeuroAI Wristband for Essential Tremor

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Fasikl, a neurotechnology company spun out of the University of Minnesota, has received FDA 510(k) clearance for its Felix™ NeuroAI™ Wristband, a noninvasive, AI-driven wearable designed to reduce upper limb tremors in adults...more

Jones Day

Vital Signs: Digital Health Law Update | Spring 2025

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Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health....more

Loeb & Loeb LLP

FDA Unleashes AI to Review Product Applications

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The U.S. Food and Drug Administration (FDA) has been ahead of the curve for a number of years on emerging issues and opportunities for the agency and regulated industry arising from the advent and evolution of artificial...more

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