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Singleron's Matrix NEO™ Receives World's First Class II Medical Device Approval for Automated Single Cell Analysis
Singleron's Matrix NEO™ Receives World's First Class II Medical Device Approval for Automated Single Cell Analysis

Singleron’s Matrix NEO™ Receives World’s First Class II Medical Device Approval for Automated Single Cell Analysis

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Regulatory milestone enables single cell sequencing to enter routine clinical diagnostics

COLOGNE, GERMANY – November 14, 2025  –  Singleron Biotechnologies announced today that its Matrix NEO™ automated single cell processing system has received Class II Medical Device Registration approval from the Jiangsu Medical Products Administration, China (Registration No.: 20252222135). Matrix NEO is the world’s first automated single cell analysis platform to achieve medical device clearance, marking a milestone in bringing single cell sequencing from research laboratories into clinical practice.

Addressing Critical Clinical Translation Barriers

While single cell sequencing is widely used in basic and translational research, clinical adoption has been limited by manual workflows, high costs, complex data interpretation, and regulatory uncertainty. Matrix NEO’s approval validates the platform’s consistent, reliable performance in single cell isolation, lysis, and mRNA capture—meeting the stringent quality standards required for clinical diagnostics.

Complete End-to-End Clinical Workflow

Matrix NEO integrates with Singleron’s end-to-end single cell workflow, including:

This end-to-end automation streamlines the path from sample collection to actionable clinical insights, reducing technical variability and accelerating time-to-result.

Advancing Precision Medicine

The approval reinforces Singleron’s commitment to advancing precision medicine. The company supports global initiatives including CERTAINTY, B2B-RARE, and AD-Omics. Singleron anticipates that Matrix NEO’s regulatory clearance will accelerate adoption of single cell diagnostics in oncology, immunology, and beyond.

About Singleron Biotechnologies

Founded in 2018, Singleron Biotechnologies is dedicated to advancing human health through pioneering single cell multi-omics solutions. With a portfolio that includes instruments, reagents, bioinformatics software, and a comprehensive single cell knowledgebase, Singleron operates globally with offices and facilities in Germany, Singapore, the US, and China. Singleron products are used in over 5,000 laboratories worldwide, spanning hospitals, research institutes, and pharmaceutical companies. For more information, visit https://singleron.bio

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