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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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• By Ashley Yeo

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