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Tag: medical device grouping

MDA Guidance on Medical Device Grouping: Overview | MDA

The article provides a brief overview of the approach to be applied concerning the classification of medical devices. It highlights the key points to...

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AI Device Clinical Evaluation Guideline and Seven Others to be Released Soon

The committee meeting of the China Artificial Intelligence Medical Device Innovation Cooperation Platform was held online on September 21, 2022. Focusing on bio-digital integration,...

Alexander Tokman Joins Izotropic Board of Directors

Vancouver, British Columbia--(Newsfile Corp. - November 11, 2022) - Izotropic Corporation (CSE: IZO) (OTCQB: IZOZF) (FSE: 1R3) ("Izotropic" or the "Company"), a medical device company commercializing IzoView, a dedicated breast...

TGA Guidance on Clinical Evidence for Supportive Devices

The new article describes in detail the aspects related to the clinical evidence required for meshes, patches, and tissue adhesives.  Table...

FDA Guidance on Ethical Considerations for Clinical Investigations Involving Children: Study Procedures and Summary

The new article highlights the key points related to study procedures in pediatric clinical investigations, and also provides a summary of the key points...

Centinel Spine® Announces First Commercial Use of prodisc® C SK Cervical Total Disc Replacement Product

prodisc® C SK expands availability of Centinel Spine's portfolio of FDA-approved cervical total disc replacement (TDR) devices. Centinel Spine now has three cervical TDR devices...

BD Board Increases Dividend for 51st Consecutive Year

FRANKLIN LAKES, N.J., Nov. 10, 2022 /PRNewswire/ -- The Board of Directors of BD (Becton, Dickinson and Company) (NYSE: BDX) has declared a quarterly...

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