Singleron Biotechnologies received Class II medical device registration from China’s NMPA for Matrix Neo, an automated single‑cell processing platform that performs cell isolation, lysis, and mRNA capture. The company claims Matrix Neo is the world's first automated single‑cell analysis platform to achieve medical device clearance, enabling end‑to‑end clinical and translational workflows. Singleron plans to integrate Matrix Neo with its tissue preservation, automated dissociation, and code‑free bioinformatics to reduce technical variability and accelerate time‑to‑result for clinical single‑cell assays. The registration clears a pathway for broader clinical adoption in China and supports commercialization efforts in other regions. The approval underscores increasing regulatory recognition of single‑cell technologies for diagnostics and precision medicine, while raising questions about validation, interoperability, and reimbursement in clinical settings.