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Therapeutic Goods Administration (TGA) Approval for CONVIVO® and Sterile Sheath in Australia

  • Published November 11, 2020 12:00AM UTC
  • Publisher Wholesale Investor
  • Categories Company Updates

Optiscan Imaging Limited (ASX: OIL) (‘the Company’ or ‘Optiscan’) has been informed by Carl Zeiss Meditec AG (CZM) that the CONVIVO® and the Sterile Sheath (which acts as a sterile barrier between the probe of the CONVIVO® and the tissue in the brain) have both been registered on the Australian Register of Therapeutic Goods enabling those devices to be lawfully supplied for use in neurosurgery in Australia. These registrations are in addition to approvals previously received by CZM to market the CONVIVO® in the United States and Europe as CZM continues the full commercialization of the CONVIVO®, developed as part of the co-operation agreement between CZM and Optiscan.

About Optiscan

Optiscan is a global leader in the development of microscopic imaging and related technologies for screening, surgery and medical research. Based in Melbourne, Australia, Optiscan has developed and patented endomicroscopic technology which enables real-time, 3D, ‘in vivo’ imaging of human tissue at the cellular level – instant “virtual biopsies” with applications for cancer screening and surgical margin determination. Optiscan’s technology has the capability to improve patient welfare, reduce hospital costs, improve accuracy and reduce the need for multiple procedures. The technology is approved for use in brain surgery and is involved in a number of oral cancer and breast cancer studies.

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