Does anyone know if we have gone to the FDA with emergency clearance hopes? In some cases the FDA has given the green light to other companies with their products considered to be worthwhile to help facilitate the diagnosis and monitoring of COVID. For example Gmedical have applied for and received FDA approval for one of its products and is waiting on, and confident of approval on the other. Dr Kvedar would have a fair degree of clout you would think. Surely the diagnostic capabilities for pneumonia would help it secure approval for the USA. Dr Kvedar would know about the clinician's deficiencies in 30% of the cases.
Or, conversely, maybe they were advised not to. Sorry if this has been discussed before.
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