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SME Success: How Eyenuk Traversed ’Stringent’ EU MDR For AI Eye Screening System

 
• By Eliza Slawther

The new EU Medical Device Regulation sets a high bar for medtech companies. Kaushal Solanki, founder of US-based Eyenuk, tells Medtech Insight how the firm navigated the new regulation and gained two extra indication approvals for its class IIb eye screening device.

EyeScan
• Source: Shutterstock

Eyenuk is well-versed in EU medtech regulations, having received a CE mark in 2015 under the medical devices directives (MDD) for its autonomous EyeArt artificial intelligence (AI) eye screening system to detect diabetic retinopathy.

More recently, the Californian digital health firm has had to grapple with the transition to the EU’s stricter Medical Device...

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More from Diagnostics

‘Eyes – A Window Into The Heart’: Retinal AI Tool Predicts Future Risk Of Heart Attack And Stroke

 
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A deep-learning AI-based retinal image scanning tool can predict the risk of cardiovascular events over a 10-year period with 70% accuracy. The test is comparable to routine GP health checks, researchers from the University of Dundee have shown.

Whoops! FDA Says Company Marketed Unauthorized Device. The Company Says The FDA Is Wrong

 
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• By Marion Webb

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