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A roadmap by the FDA for incorporating digital health technologies in clinical trials

Digital Health Global

The FDA has announced several guidelines and plans to hold at least one public meeting on digital health technologies (DHTs) to be used in drug clinical trials by the end of the year. Drug development process questions the reliability and accuracy of DHT products.

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Digital Health Technologies in Clinical Trials

Digital Health Global

Digital Health Technologies ( DHTs ) have revolutionized the landscape of clinical trials, particularly in neurology research, by enabling the collection of real-world data outside traditional clinical settings.

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Koneksa Announces New Multi-Domain Model for Functional Status Assessment Enabled by Digital Health Technologies

Digital Health Global

Koneksa’s innovative digital model aims to address limitations in existing functional status assessments by leveraging digital health technologies (DHTs) for both objective and self-reported outcomes. Chief Medical Officer, Koneksa. Chief Scientific Officer, Koneksa.

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Deliberate AI Announces its Depression and Anxiety Model, AI-COA™, is the First AI/ML Initiative to Be Accepted into the FDA’s ISTAND Pilot Program to Advance Drug Development

Digital Health Global

NEW YORK–(BUSINESS WIRE)– Deliberate AI , a digital health technology company that delivers precision measurement of mental health through AI, today announced its inclusion in the U.S. Food and Drug Administration (FDA) Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot Program.

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Indivi to Collaborate with Biogen to Advance Digital Health Technology and Digital Biomarkers for Parkinson’s Disease

Digital Health Global

BASEL, Switzerland–(BUSINESS WIRE)–Indivi, a leading MedTech company headquartered in Basel, Switzerland, has entered into an agreement with Biogen to advance digital health technology and develop digital biomarkers for Parkinson’s disease.

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How Digital Health improves patient experiences in Alzheimer’s care

Digital Health Global

Despite a history of drug development failures in the field, recent work provides reason for optimism, showing a possible therapeutic arsenal to limit disease progression at an early stage.

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Navigating the FDA DHT Guidance: Perspectives from Across the Industry

ActiGraph

Digital health technologies (DHT) can collect objective, multi-dimensional data passively and remotely with a limited burden for clinical trial participants, providing a way to capture previously inaccessible insights to support drug development and commercialization.