Crafting Superior Health Software: IEC 82304-1 ComplianceIEC 82304-1:2016 is tailored to health software products designed to operate on general computing platforms without dedicated hardware. It is aimed at products intended for the market and…
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ISO 14971 is a pivotal standard for risk management in the design and production of medical devices, emphasizing the importance of assessing and controlling risks throughout a product’s lifecycle. Here’s an in-depth look at…
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Background: The rapid growth of digital health apps has necessitated new regulatory approaches to ensure compliance with safety and effectiveness standards. Nonadherence and heterogeneous user engagement with digital health apps can lead to trial…
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Are you a digital health entrepreneur looking to navigate the complex landscape of ISO certifications? Our latest video illustrates the world of ISO and standardization regulations, providing you with the essential roadmap to elevate…
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What You Should Know: Today, Anumana, a nference portfolio company working in collaboration with Mayo Clinic, announced it has received its first 510(k) clearance from the U.S. FDA for its ECG-AI LEF algorithm. – ECG-AI LEF is Anumana’s…
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Erkin Otles – AI Practice Lead – HTD Health What You Should Know: – HTD Health, a New York-based company specializing in virtually-enabled care, EMR integration, and Software as Medical Device (SaMD) design and development, is…
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UK-based digital health tech company Huma has received FDA 510(k) Class II clearance for its configurable disease-agnostic Software as a Medical Device platform, which includes the company’s cardiovascular risk score algorithm. The company, which received…
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Huma Therapeutics has received US Food and Drug Administration (FDA) Class II clearance for its disease-agnostic Software-as-a-Medical-Device (SaMD) platform, enabling companies to launch their own algorithm innovations more quickly to the platform and allowing…
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Digital health platform blueBriX has expanded into the pharmaceutical sector, enabling pharma to leverage software as a medical device (SaMD)-compliant solution to improve patient experience and drive revenue growth.blueBriX has been designed to provide…
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The following is a guest article by Hakim Yadi, PhD OBE, Co-Founder and CEO at Closed Loop Medicine
Healthcare has historically taken a ‘one size fits all’ approach, which misses the ability to treat all…
