Analysis

Plexus achieves FDA approval to manufacture Aixplorer ultrasound systems for SuperSonic Imagine in Kelso, Scotland

27th October 2011
ES Admin
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Plexus achieved the accreditation following a thorough assessment of its work with SuperSonic Imagine, a French medical OEM, to design and manufacture its Aixplorer ultrasound system. Plexus has worked closely with SuperSonic Imagine through the product realization process, providing support with prototyping, live scan testing, electronic and high level systems assembly as well as providing direct order fulfilment. Plexus, which also holds ISO13845 accreditation in recognition of the quality management systems in place at its Kelso manufacturing facility, has the capabilities to configure Aixplorer® to the specific requirements of SuperSonic Imagine customers prior to shipping.
“Plexus has a proven track record in creating high complexity medical electronic devices,” comments Chris Griffin, Senior Director of Customer Management EMEA. “As well as our high standards of accreditation, we understand the needs of our medical customers and can offer the flexibility, expertise and support to design and manufacture the next generation of industry leading medical devices. We are very proud to be engaged with SuperSonic Imagine on this programme”.
“It is extremely important to us to work with an integrated partner who can support us in producing our highly innovative ultrasound systems,” adds Pascal Roncalez, Hardware Director, SuperSonic Imagine. “SuperSonic Imagine is now marketing Aixplorer to the United States directly from Plexus’ Kelso facility, offering our customers the option of customised configuration to meet their specific requirements.”

Aixplorer is based on a flexible software structure which allows an image acquisition rate of 200,000 images per second and is the only ultrasound system on the market that uses breakthrough MultiWave Technology, ensuring impeccable image quality and providing revolutionary ShearWave™ Elastography. ShearWave Elastography displays, in real time, true local tissue elasticity in a colour-coded map to better characterise and assess tissue stiffness. Recently the Aixplorer extended the limits of ultrasound technology by introducing UltraFast™ Doppler, uniting colour flow imaging with pulsed wave Doppler for comprehensive flow information without compromises and complete spectral Doppler analysis in seconds. The Aixplorer is a complete ultrasound system with FDA approval and CE Mark since 2009, and with several applications: breast, liver, abdomen, thyroid, musculoskeletal, prostate, gynaecology, 3D breast and vascular.

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