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Clear-Cut Medical receives CE mark approval for ClearSight MRI system

Clear-Cut Medical has received CE mark approval for its a compact magnetic resonance imaging system, ClearSight MRI, to examine breast tissue.

The ClearSight system has been developed to assess the margins of excised breast lumps taken from breast cancer patients undergoing Breast Conserving Surgery or Lumpectomy procedures.

The approval allows the company to commercialise the system in Europe.

Clear-Cut Medical CEO Eyal Kolka said the MRI is well recognized as the modality of choice for breast imaging, but due to its size and cost it was practically not accessible in real time for assisting surgical procedures.

"Currently as high as 30% of breast cancer patients undergoing lumpectomy return for a re-do operation due to ‘positive margin’ analyzed by a pathologist within one week or more," Kolka added.

"Now, our ClearSight system brings the power of MRI into the operating room aiming to assist the breast surgeon in improving the quality of care."

Established in 2010, Clear-Cut Medical is engaged in developing MRI technology for real-time assessment of excised tissue.