FDA Approval - before 29 July

With 12 days to go until the 90 day 'FDA approval window' is up, I've been drifting all over the net to try and find any hint at an FDA approval. Medibio submitted their 510K application on 30 April - meaning the decision should be known on or before 29 July.

April 30, 2020:
Mental health medtech company Medibio (ASX: MEB) has continued its accelerated plans towards FDA approvals under new management with the company having lodged an FDA application overnight for their mental health screening software – MEBsleep.

Having collected the required clinical data MEBsleep (previously named STAGER) tested more than 1,000 individuals using Medibio’s sleep staging algorithm to identify sleep disorders, their onset and progression which are key depressive symptoms targeted by Medibio.

“I am pleased to announce today that Medibio has lodged its 510K application to the Food & Drug Administration (FDA) for our sleep staging software ‘MEBsleep’”, Medibio Chief Medical Officer, Dr Archie Defillo.

“I am particularly proud to inform shareholders that MEBsleep has been developed and submitted on time and below budget. This is a significant step in the path to our depressive burden medical software device for patients with primary and secondary sleep disturbance.”

“It is also important to note that MEBsleep has a commercial path in itself and we are actively seeking collaborations for commercialisation in the USA”.

Within the 510K application, Medibio’s final analysis showed superior results which had 85% alignment with a consensus panel of certified sleep technicians when compared to its chosen predicate device with 73% accuracy.

Whilst manual identification of sleep stage by certified sleep technicians is the industry gold standard, it remains time consuming and costly. This highlights the opportunity for MEBsleep’s deep learning algorithms which are driven by artificial intelligence to accurately identify sleep disorders.

The FDA application follows through with the roadmap introduced by new Managing Director Claude Solitario, an original founder of the company and its largest shareholder, who was appointed in December 2019 with the specific intent of advancing Medibio’s FDA pathway.

Is their any more information out there that anyone can see from FDA? The june-2020-510k-clearances list is public, so I gather the FDA post a list of approval each month and it's not an ongoing live "feed". I'm very curious to find out more. But I doubt it will be public before an ASX announcement. All signs are positive at this stage of the process.