FDA green light for TrueField

Imaging technology specialist Seeing Machines has received approval from the US Food and Drug Administration (FDA) to launch its TrueField Analyzer (TFA) into the US medical market.

According to Canberra, Australia-based Seeing Machines, the TFA device offers a number of benefits over traditional techniques of measuring a patient’s visual field, such as the standard automated perimetry (SAP) devices. Such examinations are intended to detect and manage eye diseases that include glaucoma, diabetic retinopathy and age-related macular degeneration.

The TFA measures both eyes simultaneously and can complete an examination of a patient’s periphery vision in five minutes, including rest breaks within the test. While the SAP devices requires patients to repeatedly press a button, the TFA only needs patients to look at a display, which makes the test more objective.

‘Clearance by the FDA is an important milestone in the development of both the TrueField Analyzer and our company, and paves the way for the introduction of the TFA to the highly significant US market,’ said Dr nick Cerneaz, CEO of Seeing Machines.