FDA approval enhances medical offering

Product realisation company, Plexus, has received approval from the Food and Drug Administration (FDA) to manufacture finished class II medical devices at its manufacturing site in Scotland. The accreditation follows its work with SuperSonic Imagine, a French medical OEM, to design and manufacture its Aixplorer ultrasound system.

Throughout this process, Plexus was able to provide support with prototyping, live scan testing, electronic and high level systems assembly. It also offered direct order fulfilment, configuring Aixplorer to the specific requirements of SuperSonic Imagine customers prior to shipping.

Aixplorer allows an image acquisition rate of 200,000 images per second. It can display local tissue elasticity in real time, using a colour-coded map to characterise and assess tissue stiffness as well as combining flow information with spectral Doppler analysis.

Senior director of customer management EMEA, Chris Griffin, said: “Plexus has a track record in medical electronics. As well as our accreditation, we understand the needs of medical customers and can offer the flexibility, expertise and support to design and manufacture the next generation of medical devices.”