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by 5440
1096 days ago
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I'm a regulatory consultant and I am currently submitting at least 5-10 510ks/DeNovos per week to FDA for AI/ML devices for a variety of companies. I can't imagine the actual throughput from companies as I am just one person out of many consultants out there. 95% of the software devices I edit and submit are hosting their databases on AWS. Essentially they transer the DICOM images to AWS and then run their algorithms against the data and then present the indications to the physcian. These run the range of CT/MRI/Ultrasound/pathology slides/genomic sequencing. Like I said, most of the databases are on AWS. A few are on Azure and a few european companies are on Orange. |
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Okay so aside from the physician in question presumably knowing to whom a given set of indications belong to among his patients, how is the data kept anonymized while going through its path from these software devices, to AWS, to algorithmic processing and then to presenting findings to the physician?
and those DeNovos you're submitting, what do most of them relate to? Honestly curious since you describe how you work in this field.