Research & Development
Notal Vision passes US FDA breakthrough device designation for patient-operated home optical coherence tomography (OCT) system
4 December 2018 -

Ophthalmic company Notal Vision Ltd reported on Monday the receipt of the US Food and Drug Administration (FDA) 'Breakthrough Device' designation for the Notal Vision Home-based Optical Coherence Tomography (OCT) System for the automated testing in exudative age-related macular degeneration (eAMD) patients.

The company said the Notal Home OCT is a patient-friendly light-weight device designed for technician-free operation by eAMD patients from the comfort of their home. Once a patient completes the test, a proprietary machine-learning algorithm, the Notal OCT Analyzer (NOA), performs an automated analysis. If retina fluid is detected, a report is generated by NOA which is then conveyed to the treating physician by the Notal Vision Diagnostic Clinic.

Following a report, patients may be brought to the office for evaluation and treatment at the physician's discretion. The Notal Home OCT has the potential to truly individualise retinal disease management, added the company.

In addition, the company plans to launch the Notal Vision Home OCT System to the market in 2020.

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