Medical Innovation Exchange

SaMD

FDA-Cleared SaMD by the Numbers

FDA-Cleared SaMD by the Numbers     If industry buzz is any measure of actual activity, then Software as a Medical Device (SaMD) is the current darling of the MedTech world. Despite this, it’s difficult to quantify just how many SaMD have reached the market in the U.S. While the information needed to identify a medical …

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Navigating Global Regulations for SaMD

Navigating Global Regulations for SaMD     As patients increasingly seek tailored medical care that aligns with their unique needs and preferences, digital-first software resources such as Software as a Medical Device (SaMD) have become the need of the hour. SaMD solutions collect and analyze individual patient data, equipping clinicians and patients with personalized insights. A …

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Leveraging Gamification and AI: The Future of Mental Health Care

Leveraging Gamification and AI: The Future of Mental Health Care     Mental health issues encompass a range of conditions affecting an individual’s emotional, psychological and social well-being. From depression and anxiety to more severe conditions like schizophrenia, these challenges have historically been addressed through various therapeutic modalities. In recent years, technology has begun to play …

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Unlocking Success in SaMD Product Launches Through AI

Unlocking Success in SaMD Product Launches Through AI     The field of digital health is rapidly transforming healthcare. With the integration of technology, clinical data and analytics, digital health is improving patient care, diagnostics and treatment methods. More specifically, Software-as-a-Medical-Device (SaMD)—a subsector of digital health—is gaining traction in both industry scale and innovative solutions. However, …

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Bringing Digital Health Products to the Global Market

Bringing Digital Health Products to the Global Market     In recent years, the growth and acceptance of digital health products has skyrocketed. Global regulation and market access for these devices, however, is as variable as the potential indications they address. We spoke with Megan Coder, Vice President for Product and Policy at the Digital Medicine …

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Advancing Digital Health: Huma SaMD Platform Gains U.S. Clearance

Advancing Digital Health: Huma SaMD Platform Gains U.S. Clearance     This week Huma Therapeutics received 510(k) clearance for its configurable Software as a Medical Device (SaMD) disease management platform, which previously received Class IIb approval in the EU. The FDA Class II clearance allows users to add AI algorithms to the disease-agnostic platform, potentially speeding …

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Software and Artificial Intelligence as a Medical Device

Software and Artificial Intelligence as a Medical Device     Earlier this month, the UK Medicines & Healthcare Products Regulatory Agency (MHRA) issued the guidance document, “Software and Artificial Intelligence as a Medical Device.” The guidance brings together current guidances, advice and regulatory requirements for Software as a Medical Device (SaMD) and Artificial Intelligence as a …

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