Institute of Good Manufacturing Practices India®

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Scopio Labs obtains de novo nod for bone marrow analysis software

Founded in 2015, Scopio aimed to revolutionize microscopy and has since achieved significant milestones. These include obtaining CE marks and FDA clearances, raising $66 million through series B and C financing rounds, and forming partnerships with Beckman Coulter and Siemens.

The FDA cleared Scopio's X100 device in 2020 and its high-throughput variant, X100HT, in 2022. These clearances authorize the devices to locate and display images of blood cells from peripheral blood smears.

Moreover, Scopio received de novo authorization for applying X100 and X100HT to bone marrow aspirate, aiding in evaluating blood diseases. This necessitated using the de novo pathway, as it breaks new ground compared to the predicate device, Medica's Easycell Cell Locator.

The FDA introduced special controls as part of the authorization, including performance data documentation and labelling requirements. These controls mitigate the risks of false positive and false negative results and facilitate similar devices' market entry via the 510(k) pathway.