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Tag: Food and Drug Administration

FDA Draft Guidance on Third-Party Review: 3P510k Eligibility Factors | United States

The article highlights the key points associated with factors to be considered when determining the eligibility of a medical device type for a third-party...

FDA Draft Guidance on Real-World Evidence: Considerations for Collection and Analysis | United States

The  article highlights the aspects related to the key considerations for methodologies used in the context of the collection and analysis of real-world evidence. ...

Iveda launches IvedaAI Sense: AI sensor detects vaping and bullying | IoT Now News & Reports

Iveda has introduced IvedaAI Sense, an AI-based sensor that can detect smoke and vapor particles and incidents of bullying. Integrated into the IvedaAI platform,...

X-trodes Receives FDA 510(k) Clearance for Wearable “Skin” Solution that Brings Medical-Grade Electrophysiological Monitoring to the Home | BioSpace

Next-Generation Skin Patch-based Monitoring Platform Enables Complete Freedom of Movement for Patients in Both Healthcare and Home Settings HERZLIYA, Israel, Feb. 20, 2024 /PRNewswire/ --...

MCRA Assists Curiteva Inc. with FDA 510(k) Clearance for Inspire 3D Printed Trabecular PEEK Lumbar Interbody Fusion System | BioSpace

  WASHINGTON, Feb. 20, 2024 /PRNewswire/ -- MCRA, the leading privately held independent medical device, diagnostics, and biologics Clinical Research Organization (CRO) and advisory firm is...

FDA Draft Guidance on Translation of GLP Study Reports: Overview | United States

The article provides a brief overview of the approach to be followed for the reports related to studies and reports associated with it. ...

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