SONDA Screener

Primary DI

08720892364708

Basic UDI-DI Code

87208923647SCREENERNT

Reference

SONDA Screener

Device Types

None provided

Regulation

Eu Mdr

Classification

Eu Md Class 1

Status

On The Market

Manufacturer

Reyedar B.V.

SONDA Screener is a medical device intended for collecting and processing eye-tracking data using advanced data analytics. The device is intended to be used by healthcare professionals in a controlled environment in order to perform a non-invasive functional vision test. SONDA Screener does not claim a diagnostic function for any specific pathology. It is solely intended to show how functional vision parameters related to eye movements deviate from a normative dataset based on general population data. The device alerts the user for unusually high deviation potentially requiring further investigation, using a colour coded qualitative risk indication. The medical purpose of the device is to screen individuals with potentially abnormal functional vision, based on eye movement behaviour. A disrupted eye movement behaviour has been positively linked to an array of neurovisual disorders. The device offers a concrete individual and public health benefit by increasing the number of accurate referrals while reducing their false positive rate, potentially leading to an increased number of early diagnoses. The core medical function of the device relies on the proprietary data processing algorithm Screener MDSW, designed and produced by Reyedar B.V. Screener MDSW is an integral component of the SONDA Screener medical device, it is not commercially available on its own and it is not a device in its own right.

Other on-the-market devices with the same classification (Eu Md Class 1) and regulation (EU MDR).