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.
You may also be interested in...
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.
The UK MHRA approved a new version of Amgen’s established bone cancer complication drug Xgeva based on a review conducted by the European Medicines Agency.
An analysis spanning two decades found that 65% of health technology assessments in England were based on evidence of poor or unacceptable quality, raising concerns around the efficacy of drugs reaching patients.