ARTICLE SUMMARY:
Rick Abramson picked to lead FDA’s Digital Health Center of Excellence. Excerpted from Pathways’ Picks Febraury 25: Tariff Topsy-Turvy, CPT Panel Decisions, Reliance in South Africa.
Radiologist and former health AI industry executive Rick Abramson, MD, was tapped earlier this month to lead FDA’s Digital Health Center of Excellence, a post that was vacant since last summer. Abramson, who has been serving as contract advisor to FDA Commissioner Marty Makary, MD, since last 
June was previously chief medical officer of Annalise.ai, a subsidiary of AI imaging analysis software firm Harrison.ai. He also previously was an executive at clinical analytics firm Covera Health. Abramson is reported to have played a key role in FDA’s recent activity aimed at streamlining digital health regulations, including guidance updates for clinical decision support and general wellness products and the recent launch of the TEMPO pilot. Notably, Harrison.ai has an active petition before FDA to exempt multiple categories of radiological analysis software from 510(k) requirements when a manufacturer has prior experience with the relevant product type and has implemented a robust post-market plan.