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Claros Point-of-Care Diagnostic System

Claros Point-of-Care Diagnostic Systems

Claros Diagnostic System as an example of POC Medical Device Design

The Challenge

Claros Diagnostics aimed to bring rapid, lab-quality blood testing to the point of care enabling clinicians to get real-time results and engage patients immediately. The goal was to design a diagnostic system that was simple enough for untrained users, but powerful enough to perform complex assays with precision and speed. It also needed to support a broader product roadmap and achieve FDA and CE-Mark approvals.

The Solution

Suntra MedTech Solutions developed a flexible diagnostic platform in just six months, delivering the Claros® 1 Analyzer a benchtop system capable of running quantitative blood tests in minutes. We engineered the electronics and software to control microfluidic disposable cassettes and accurately analyze optical sensor data. The system’s modular architecture was built for adaptability, allowing for both clinical and research use across a range of test types. Suntra also supported manufacturing transfer, as well as regulatory pathways for FDA and CE-Mark approvals.

The Impact

The Claros® 1 Analyzer empowered clinicians to conduct lab-grade diagnostics at the point of care, reducing turnaround times and improving patient conversations. Its scalable design laid the foundation for a full family of products accelerating Claros’ entry into a competitive market with confidence and speed.

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