MedTech World Dubai: Amplifai Health’s AI Diabetic Foot Scanner Gets SFDA Green Light

Amplifai Health has received medical device marketing authorization from the Saudi Food and Drug Authority (SFDA) for its Thermal Foot Scan (TFscan), the world’s first software as a medical device (SaMD) for diabetic foot screening. This milestone underscores a major advancement in early detection and prevention of diabetic foot ulcers (DFUs), a leading cause of lower-limb amputations worldwide.

The Growing Threat of Diabetic Foot Ulcers

Diabetes remains a global health challenge, with over 800 million people currently affected, a number projected to exceed 1 billion by 2030. Among its severe complications, DFUs stand out as a major concern, contributing to 1.8 million amputations annually. In Saudi Arabia alone, 18.7% of adults are diabetic, emphasizing the urgent need for proactive healthcare solutions.

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