SME Success: How Eyenuk Traversed ’Stringent’ EU MDR For AI Eye Screening System
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.
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MHRA Grants Extra Year For CE-Marked Devices To Access UK Market
The UK regulator is likely to establish mid-2024 as the new deadline for the standstill period during which CE-marked devices may access the UK market. Compulsory UKCA marking would accordingly also be delayed by a year.
Huma Secures EU MDR Approval For Medtech Software That Can Be Used In Any Disease
Huma Therapeutics has secured the first ever EU regulatory approval for a “disease agnostic” class IIb medtech software platform. CEO Dan Vahdat tells Medtech Insight how the product can be configured to monitor patients with any condition.
How Innovative UTI Diagnostics Can Help Combat Antibiotic Resistance
UTIs are one of the most common reasons for antibiotics to be prescribed, but accurate and timely diagnostic tools are lacking. England’s NICE has identified four innovative IVDs that could be rolled out for NHS patients, but said more research is needed on these products first.