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Angle Files De Novo Submission For Parsortix System In Breast Cancer

 
• By Catherine Longworth

The system has the potential to be the first FDA-cleared device for harvesting intact cancer cells from a blood sample for subsequent analysis.

Cancer cells on scientific background.3d illustration

UK liquid biopsy company ANGLE plc has filed a de novo submission with the US Food & Drug Administration for its Parsortix system to capture metastatic breast tumor cells

The system is designed to harvest circulating tumor cells (CTC's) from a patient’s blood sample with a microfluidic cassette ....

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HistoSonics’ Edison System Gains Limited UK Access, While Awaiting CE Marking

 
• By Shubham Singh

While HistoSonics is awaiting the CE mark in Europe, it hit a major milestone by securing early limited market access in Great Britain under a Unmet Clinical Need Authorization (UCNA), bringing its noninvasive histotripsy treatment to patients with liver tumors.