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


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

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Optiscan Imaging Limited (ASX: OIL) (‘the Company’ or ‘Optiscan’) is pleased to announce that it has received written feedback from the Center for Devices and Radiological Health (CDRH) of the FDA in response to specific questions raised by the Company following its meeting with the FDA in January 2020 and subsequent written submissions made in late June 2020.

Following this feedback, Optiscan will continue to prepare its submission for 510(k) clearance to market the InVivageTM device for legal sale in the United States in Oral Cancer Screening and/or Surgery. In particular, Optiscan is pleased with the affirmative responses from the FDA regarding the proposed Product Code, Primary Predicate Device and use of the CONVIVO® device as a Reference Device.

The next step is the clinical study regarding the effectiveness (dosing and time to imaging) of the use of a topically applied imaging agent for use in conjunction with the InVivageTM device will be conducted with the Melbourne Dental School and will take place simultaneously with the third party validation and verification testing which is required to be completed for the 510(k) submission. This testing will commence in the current quarter.

The completion of all these components form the path to 510(k) submission planned for the first half of 2021.

About Optiscan

OptiScan (ASX:OIL) is an Australian listed company and a pioneer in the development and application of endomicroscopic imaging technologies for medical markets.   Our multi-patented confocal imaging technology can be used for both cancer screening and tumour margin detection in cancer surgery.  Our device enables real-time, in vivo imaging at the cellular level in clinical applications, providing a “digital” biopsy.  The benefits of this “digital” biopsy include monitoring of early stage disease, earlier identification of pre-cancer and the potential to reduce the time doctors, patients and operating theatres are required to wait for pathology results, the number of repeat surgeries and actual biopsies required.

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