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CelLBxHealth will drop its FDA license for Parsortix® as over 97% of units are used for research, not commercial sale.
CelLBxHealth plc announced on February 13, 2026, that it will discontinue maintaining its FDA establishment license and device listing for the Parsortix® system, citing that over 97% of units are used for in-house research where FDA listing provides no commercial benefit.
The move, aimed at improving cost efficiency, allows the company to redirect resources toward revenue growth, customer support, and product development.
The decision does not impact sales, forecasts, or partnerships, and CelLBxHealth retains the ability to reinstate the FDA listing at any time.
CEO Peter Collins said the change aligns with current customer usage and supports long-term growth in precision oncology.
The company continues expanding collaborations in research, clinical trials, and lab-developed tests.
CelLBxHealth retirará su licencia de la FDA para Parsortix®, ya que más del 97% de las unidades se utilizan para investigación, no para venta comercial.