Automated retinopathy analysis system application software

Intended purpose

The RetInSight GA Monitor is a medical device for professional use only, intended to quantify the lesions of the pathological integrity loss areas in the retina (i.e. Retinal Pigment Epithelium (RPE) Loss and Photoreceptor (PR) Degeneration) to support therapeutic decisions in the management of Geographic Atrophy (GA) in AMD. Results from the RetInSight GA Monitor should not be the sole basis for a patient diagnosis or therapeutic decisions. Results generated by the RetInSight GA Monitor should be considered along with the assessment of the patient´s history and the current clinical condition of the patient and the affected eye.