Q-LINEA AB Q-linea AB (publ) announced that the company has completed its 510(k) application for US market approval. At the FDA's recommendation, Q-linea conducted additional analytical and clinical studies to support the company's 510(k) application for U.S. market authorization. Q-linea has had a continuous dialogue with the FDA, something that has likely been facilitated by ASTar's Breakthrough Device designation.
As previously communicated, however, it is difficult to assess the timing of market approval in the US. The FDA may have additional questions and the processing time is hard to estimate. The FDA's recommendation to conduct additional testing was prompted by an algorithm update and was primarily aimed at verifying the performance improvements brought about by the algorithm update.
The update was made as training data was expanded after the clinical study in the 510(k) application was completed. The training data is the basis for the machine learning algorithms that AStar's software uses to calculate results. Similar performance improvements for ASTar are already implemented for the European market.
