@croxil Lots of good info but not all of it is correct."This may...

@croxil Lots of good info but not all of it is correct.

"This may mean the process is on hold due to an Additional Information (AI) Request. Which Medibio has 180 days to submit. The end date for this is mid February 2021."
Company was asked for additional information which company provided in due course. Company has received follow up communication from FDA regrading this "Additional Information". In the follow up communication FDA said they are happy with the response received from the company and the process has moved to substantive review process on 24th of August which should take 60days to complete which is now well over due.

From Company Announcement of 31/08/2020,
FDA 510(k) Application for MEBsleep
As reported on 30 April, Medibio submitted an FDA 510(k) application for its sleep staging medical
software, MEBsleep. MEBsleep uses artificial intelligence, deep learning algorithms and neural network
methodology to identify the five important sleep stages that are required for the accurate identification
of sleep disorders. The primary purpose of MEBsleep is the identification of sleep stages, which is a
critical part of its depressive burden algorithms and related platform MEB-001. However, MEBsleep has
commercial value in its own right.
Following the 501(k) submission, Medibio responded to queries from the FDA to provide clarification of
the intended use for MEBsleep and questions related to its predicate device. Requests of this nature are
common as part of the 510(k) review process given this particular submission pathway rests on the
submitted device being ‘substantially equivalent’ to a predicate device.
Following on from our update dated 7th August 2020, on the 24th August 2020, US Central Time, Medibio
received communication from the FDA that its application was found to contain all the necessary elements
and information needed to proceed with a substantive review. As a result, Medibio can now confirm its
application has progressed to the FDA’s substantive review phase.

GLTAH