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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 Diagnostic Imaging

PathAI Expands AISight Dx Label With PCCP-Guided Addition Of Roche Scanners

 
• By Natasha Barrow

Roche’s scanners have been integrated with PathAI’s AISight Dx system. The system’s FDA-cleared PCCP allows new components to be validated and integrated without additional FDA clearance. Eric Walk, chief medical officer, hints at future biopharma companion diagnostic collaborations.

Sweden’s Sectra Expands Global Digital Pathology And AI Footprint

 
• By Ashley Yeo

Cloud services accounted for 85% of Sectra’s imaging IT solutions business in 2024-25, and the Swedish medical diagnostic imaging and IT for precision medicine company is further expanding its digital healthcare and AI coverage in the UK, wider Europe and US.

Tariffs In Focus: Projections From 4 Medtech Giants (Q1 Vs Q2)

 
• By Marion Webb, Shubham Singh, and Nancy Pham

Roche Diagnostics, Intuitive Surgical, Abbott and Edwards Lifesciences all acknowledge tariff headwinds, but stress preparedness, resilience and mitigation. Below is look at how management framed the impact in Q1 vs Q2 earnings calls.

Philips Announces Major Investment In US Manufacturing And Expansion Of Pennsylvania Facility

 
• By Brian Bossetta

Philips says the expansion of its facility in Reedsville, PA, will not only boost its capacity to produce AI-enabled ultrasounds that are used in hospitals across the US but will also create 120 well-paying jobs.

More from Diagnostics

Sweden’s Sectra Expands Global Digital Pathology And AI Footprint

 
• By Ashley Yeo

Cloud services accounted for 85% of Sectra’s imaging IT solutions business in 2024-25, and the Swedish medical diagnostic imaging and IT for precision medicine company is further expanding its digital healthcare and AI coverage in the UK, wider Europe and US.

NextGen Dx Panel Expects Continued Limbo On LDT Regulation

 
• By Elizabeth Orr

A recent conference panel discussed the stagnation in diagnostics regulation, highlighting the FDA's failed regulatory efforts on lab-developed tests. Political and legislative challenges hinder other reforms, and concerns over Medicare reimbursement cuts loom for the clinical lab industry.

Quest’s Haystack MRD Wins FDA Breakthrough Status, Shows Exceptional ctDNA Sensitivity

 
• By Shubham Singh

Quest is actively building collaborations with academic and pharmaceutical partners to integrate Haystack MRD into clinical investigations. These partnerships are not yet public but span multiple tumor types and therapeutic areas, VP Dan Edelstein said.