FDA

Human Factors Methodology in Medical Device Design for FDA Approval

Human Factors Methodology in Medical Device Design for FDA Approval

By Sean Hägen, Founder and Director of Research and Synthesis, BlackHägen Design Human Factors Engineering (HFE) must be considered by every medical device manufacturer at some stage of the design and development journey to ensure that the final product can not only gain FDA approval, but also meet the needs of users and patients. Regulatory …

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VA and FDA Partner to Accelerate Delivery of Medical Devices

VA and FDA Partner to Accelerate Delivery of Medical Devices

The agencies will work together to create testing methods, tools and training that support medical device innovators throughout the product development cycle. WHY IS IT IMPORTANT Veterans Affairs personnel will provide the clinical context for test development while U.S. Food and Drug Administration personnel will assess the benefits and risks of medical devices to speed …

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AI-assisted polyp detection device SKOUT Nabs FDA Nod

Iterative Scopes, a precision medicine technology company focused on gastroenterology, and Provation, a software and SaaS provider of clinical productivity and workflow automation solutions, recently announced that the detection tool , SKOUT, has received 510(k) clearance from the FDA for adults undergoing colorectal cancer screening or surveillance. SKOUT is a real-time computer-aided detection device that …

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