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Updated: Nov 4, 2025

Applications of the Single-probe: Mass Spectrometry Imaging and Single Cell Analysis under Ambient Conditions
Published on: June 14, 2016
Breaking Through the Barrier: Regulatory Considerations Relevant to Ambient Mass Spectrometry at the Bedside
Michael Woolman1, Lauren Katz1, Alessandra Tata2
1Techna Institute for the Advancement of Technology for Health, University Health Network, 100 College Street, Toronto, Ontario M5G 1P5, Canada; Department of Medical Biophysics, University of Toronto, 101 College Street, Toronto, Ontario M5G 1L7, Canada.
Abstract:
Rapid characterization of tissue disorder using ambient mass spectrometry (MS) techniques, requiring little to no preanalytical preparations of sampled tissues, has been shown using a variety of ion sources and with many disease classes. A brief overview of ambient MS in clinical applications, the state of the art in regulatory affairs, and recommendations to facilitate adoption for use at the bedside are presented. Unique challenges in the validation of untargeted MS methods and additional safety and compliance requirements for deployment within a clinical setting are further discussed. Development of a harmonized validation strategy for ambient MS methods is emphasized.
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