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QT Imaging Announces Successful Completion of First FDA Routine Inspection with Zero Form 483 Observations

QTI
  • QT Imaging Holdings, Inc. completed its first routine FDA inspection with zero Form 483 observations.
  • The FDA review covered the Company's Quality Management System & related operational processes without identifying violations.
  • FDA inspectors provided positive feedback regarding the organization of QT Imaging's Quality Management System & the Company's responsiveness.
  • The absence of a Form 483 represents a significant operational milestone & validates the maturity of QT Imaging's quality systems.
  • QT Imaging operates as a medical device company focused on developing innovative imaging systems using low-frequency sound waves.
  • The Company plans to maintain high standards of quality & regulatory compliance while scaling manufacturing & expanding global commercialization.
  • QT Imaging Holdings trades on the NASDAQ under the ticker symbol QTI.