The certification covers the company’s X100 and X100HT platforms, including Full-Field Peripheral Blood Smear Application with RBC AI-powered decision support.
Scopio Labs has achieved In Vitro Diagnostic Regulation (IVDR) certification from BSI for its AI-driven digital morphology platforms, clearing the path for European Union market access.
The certification covers the company’s quality management system and full technical documentation for the X100 and X100HT platforms, including its Full-Field Peripheral Blood Smear Application with red blood cell AI-powered decision support.
The milestone builds on Scopio’s recent Food and Drug Administration (FDA) clearance for its Red Blood Cell Decision Support System, strengthening the company’s global regulatory foundation as it expands into international markets.
“This IVDR certification is a testament to our commitment to regulatory excellence at every stage of development,” says Itai Hayut, chief executive officer of Scopio Labs, in a release. “With multiple FDA clearances and IVDR certification in hand, we are ensuring that hematology labs worldwide can adopt innovative digital solutions that meet the highest global standards and integrate seamlessly into established workflows.”
Enhanced AI Capabilities Across Full Sample
The Full-Field PBS Application provides high-resolution, dynamic digital images for evaluation of white cells, red cells, and platelets. While Scopio’s AI-powered Decision Support System previously focused on white blood cell (WBC) analysis, it now includes RBC morphology and platelet clump detection across the entire sample, including the feathered edge.
The IVDR framework (EU 2017/746) introduces more stringent requirements than the previous In Vitro Diagnostic Directive. To achieve certification, Scopio’s technical documentation underwent extensive review by a Notified Body, including evaluation of analytical and clinical performance, manufacturing controls, and risk management, according to a release from the company.
Platform Specifications
Scopio Labs’ Full-Field Peripheral Blood Smear Application and Full-Field Bone Marrow Aspirate Application are FDA-cleared and CE-marked for use with the Scopio X100 and Scopio X100HT platforms. The platforms are also cleared for sale in additional regions, though the Full-Field Bone Marrow Aspirate Application is not commercially available in the US for in vitro diagnostic procedures.
The company says its technology addresses cell morphology’s traditional trade-off between resolution and field of view through high-resolution imaging and embedded AI for remote workflow through secure hospital networks.
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