Certification for TruScreen Second Generation Device – New Zealand Health & Hospital Magazine

Published: 20 April 2016

New Zealand Health & Hospital

Volume 68, No 2, March-April 2016

TruScreen Limited’s second generation cervical cancer screening device, known as ‘TruScreen Ultra’, is now ready for commercial launch in select markets following receipt of CE Mark certification. This will enable the company to distribute and sell its TruScreen Ultra device in the European Union and many other markets that view the CE Mark as an endorsement of compliance, quality and design of the device’s technology and efficacy.

“This is a significant step forward in our commercial plans, allowing us to immediately commence manufacture of our new device and fill the inventory gap caused last year when all stocks of the original TruScreen device were sold out,” says TruScreen CEO Martin Dillon.

The TruScreen Ultra device is the culmination of over two years of intensive product development and contains many new features including:

  • increased processing capacity and faster processing
  • improved performance
  • wireless handpiece with significantly increased portability
  • rechargeable battery freeing the device from reliance upon continuous connection to mains power
  • Wi-Fi connectivity to PCs, laptops and smart devices
  • Internet Browser compatibility
  • Graphic User Interface with LCD touch screen.

TruScreen’s real time cervical cancer technology utilises a digital wand which is placed on the surface of the cervix to measure electrical and optical signals from the surrounding tissue. A sophisticated proprietary algorithm framework distinguishes between normal and abnormal (cancerous and precancerous) tissue to identify precancerous change, or cervical intraepithelial neoplasia (CIN). A Single Use Sensor (SUS) is used for each patient to protect against cross-infection.

TruScreen is the only device in the world that is a CE certified, stand-alone real time primary screening tool for Cervical Cancer

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