Prolight Diagnostics today announces that it has achieved formal design freeze of the instrument for the Psyros platform, a key milestone toward clinical development and scalable manufacturing.
“Achieving instrument design freeze is a large and decisive step forward. The final design supports scalable manufacturing and reliable performance in demanding clinical environments such as ambulances and emergency departments, strengthening our position as we move towards clinical validation. Thanks to this design, we now have the potential to bring the first ultra-senstive, low cost POC platform to the market which will be best in class”, said Paul Monaghan, Head of Engineering at Prolight Diagnostics.
The design freeze concludes a development and evaluation phase conducted in close collaboration with Prolight’s development and manufacturing partner, G&H | ITL. The final instrument design incorporates refinements that improve manufacturability, system robustness, and performance in real-world clinical environements.
The finalized design supports a robust and repeatable manufacturing process, reducing key production risks and enabling the transition to pilot manufacturing using final components, suppliers, and assembly methods. Improvements in mechanical and optical stability increase resilience to environmental factors, supporting reliable operation in demanding settings such as mobile and emergency care.
With instrument design freeze achieved, Prolight will proceed with production of pilot units representative of the final commercial product. These instruments will be used for system verification and validation activities, followed by the company’s regulatory clinical performance study.