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Prescription Digital Therapeutic

Meaning

A Prescription Digital Therapeutic (PDT) is a sophisticated software-based medical device that delivers a clinically validated therapeutic intervention to patients to prevent, manage, or treat a medical disorder or disease, requiring a formal prescription from a licensed healthcare provider. These products undergo rigorous testing in randomized controlled trials and must receive regulatory clearance, such as FDA approval, demonstrating clinical efficacy comparable to traditional pharmacological treatments. They represent a new class of evidence-based, scalable, and non-pharmacological treatments for conditions ranging from metabolic syndrome to chronic hormonal mood disorders.