United States Food and Drug Administration (FDA) Regulatory Approval Update

Optiscan Imaging Limited is excited to announce that,

  • Optiscan has received written feedback from the United States Food and Drug Administration (FDA) indicating Optiscan’s 510(k) pathway remains on track for the use of its InVivage™ device in Oral Cancer Screening and/or Surgery.
  • Optiscan will commence third party validation and verification testing of the InVivage™ device in the current quarter to support its intended 510(k) submission.
  • 510(k) submission planned for the first half of 2021.

Click here to read the full announcement