Median: preliminary submissions phase finalized in the USA
This phase, which was initiated in May 2022, was intended to clarify and take into consideration the FDA's expectations around key protocol points for future pivotal studies.
Following the completion of this phase, the pivotal study protocols for iBiopsy LCS CADe/CADx medical device software are finalized and ready for the launch of pivotal studies.
Median has indicated that it intends to launch pivotal studies for its software no later than the end of the second quarter of 2023, with a view to obtaining regulatory approval in the first half of 2024.
iBiopsy integrates the most advanced artificial intelligence, machine learning and data science technologies for medical image processing.
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