Digital ultrasound company Butterfly Network has achieved EU MDR certification for the Butterfly IQ+ ultrasound system, allowing the company to release its offerings into the European market, including its AI-enabled software Auto B-Line Counter and the company’s Pulse Wave Doppler (PWD).
Auto B line Counter uses AI to help providers determine patient abnormalities by measuring B-lines. B-lines...
Thirona obtains EU MDR approval for AI eye screening software
Dutch medtech firm Thirona has been granted Class II CE certification under the EU Medical Devices Regulation (MDR) for its eye disease screening software.
The solution RetCAD uses artificial intelligence (AI) to analyse colour fundus images, showing the interior surface of the eye, for the presence of age-related macular degeneration...
The UK government has released a proposed regime on the regulation of medical devices in Great Britain, Northern Ireland and the European Union post Brexit.
Under the guidance, the Medicines and Healthcare products Regulatory Agency (MHRA) will continue to recognise CE marks and certificates issued by European Economic Area-based Notified Bodies until 30 June 2023.
From 1 July, companies will...
The countdown is on for medical device manufacturers to prepare for the EU Regulation on Medical Devices (MDR), which will fully apply in member states from May this year.
But in a recently published paper, trade association MedTech Europe raised concerns that the new regulatory system is not ready to support the transition of technology from the old regime.
The new EU MDR came into force on May...
