Search Results for 'user'
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FDA Continues User-Fee Related Reviews Through COVID-19
FDA is extending response due date for 510(k), PMA, HDE, and De Novo applications by 90 days.U.S. Food and Drug Administration 04.17.20
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R&D & Design
Supercharge Medical Device Innovation Using Effective User Preference Studies
User preference and evaluation studies have been a mainstay design tool for medical device development for decades.Philip Remedios, Principal, Director of Design & Development, BlackHägen Design 04.01.20
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FDA Clears Siemens Healthineers SOMATOM X.cite CT Scanner with Intelligent User Interface
myExam Companion automatically adapts scans based on A.I.-trained clinical decision trees to simplify image acquisition parameters and reconstruction tasks.Business Wire 01.16.20
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Electronics | R&D & Design
10 Usability Heuristics for Better User Interface Design
Follow these principles in UI design to develop a friendly, effective user interface.Online Exclusives Hannah Rusak-Gillrie, Junior Human Factors Engineer, StarFish Medical 05.30.19
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Bose's Self-Fitting, User-Controlled Hearing Aid Wins FDA Nod
The Bose Hearing Aid is a user-fitted wireless air conduction hearing aid.U.S. Food and Drug Administration 10.08.18
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An Examination of User Fees’ Impact on Review Times
Federal budgets and MDUFA IV could adversely impact the FDA’s ability to expedite product review submissions.Online Exclusives Glenn Stiegman, Tim Hunter, Keith Tode, and Jack Kiraly; Musculoskeletal Clinical Regulatory Advisers LLC 08.25.17
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Samsung Launches Versatile Ultrasound Systems Designed to Enhance the User Experience
The company's HS50 and HS60 systems strengthen the existing ultrasound portfolio.Business Wire 05.19.17
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Navigating Recent Changes To The Medical Device User Fee Modernization Act of ‘02
Navigating Recent Changes To The Medical Device User Fee Modernization Act of ‘02 Rames R. Ravitz James Hartten Since the summer, there has been a flurry of regulatory activity with respect to t…James R. Ravitz and James Hartten 11.18.05
