Roche Receives FDA Clearance for Next-Gen Lab Analyzers

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Roche announced that the FDA has cleared its new cobas® c 703 and cobas® ISE neo analytical units, which are designed to enhance efficiency and testing capabilities for clinical laboratories. The high-throughput cobas® c 703 can process up to 2,000 tests per hour, while the cobas® ISE neo delivers up to 1,800 tests per hour with reduced hands-on time through automated maintenance.

Why it matters

Laboratories are facing challenges like staffing shortages and growing test volumes, so solutions that can boost throughput and automation are crucial to supporting patient care. Roche's new analyzers aim to help labs process more samples without sacrificing performance.

The details

The cobas® c 703 can handle up to 2,000 tests per hour and has 70 reagent positions, enabling more high-value tests to run continuously. The cobas® ISE neo delivers up to 1,800 tests per hour and reduces hands-on time through automated maintenance. Together, these units automate tasks traditionally done manually, supporting labs facing staffing shortages while increasing capacity and accelerating turnaround times.

• The cobas® c 703 and cobas® ISE neo analytical units received FDA 510(k) clearance on March 30, 2026.

What they’re saying

What’s next

Roche plans to continue investing in solutions that help labs process more samples efficiently to address staffing shortages and growing test volumes.