Comments on Orthogonal's FDA-cleared SaMD Draft List

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Thanks for your contribution to Orthogonal's draft list of all Software as a Medical Device (SaMD) cleared by the FDA. Randy Horton, Chief Solutions Officer at Orthogonal, and Brian Binkowski, a seasoned SaMD consultant, have collaborated to create an initial list from publicly available FDA databases. We appreciate you taking the time to help refine this list to make it the definitive source of information on SaMD that have successfully reached the market in the U.S.

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Do you know of any additional SaMD products that are not on the list? Please provide the device names and any relevant details.

Did you notice any inaccuracies or misclassifications in the existing list? Please provide details about the errors or corrections needed.

Do you have any additional comments, suggestions, or insights?

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