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Devices and Diagnostics News: ANGLE appoints regulatory expert as Parsortix development steps up a gear

ANGLE (LON:AGL) may receive European regulatory approval for its Parsortix cancer screening device by the end of the year, according to the company appointed to oversee the process.

Medical Device Management (MDM), a specialist in regulatory submissions of medical devices, will manage the approval process for the clinical use of Parsortix.

Parsortix is a non-invasive device used to capture and identify circulating tumour circulating cells and has the potential to transform the way the disease is identified and treated.

In the European Union, marketing authorisation will be via a CE Mark, which will give approval for clinical sales throughout the EU.

In the US, the process will involve a submission of a 510(k) application to the Food and Drug Administration (FDA).

Authorisation under 510(k) will allow the company to make the product available throughout the US for use in treating patients.

MDM’s initial analysis agrees with ANGLE’s expectation of regulatory authorisation in the EU by the end of the current calendar year and a submission to the FDA in the US in early 2014.

ANGLE added it has had a stream of potential users expressing interest in the product, particularly in its harvesting capability.

Major hospitals, leading research groups and several commercial companies from the UK, US, Canada and Australia have already expressed interest, ANGLE said.

Andrew Newland, chief executive, said: “We are very pleased to have put in place a plan for securing regulatory authorisations in Europe and the United States.

“MDM are experts in this field and it is reassuring that they have expressed confidence in our ability to secure the authorisations needed to enter the multi-billion dollar market for the clinical use of our cell separating technology.”

MDM has a client base that ranges from small innovative companies to international medical devices businesses.

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