Staci Kearney, Elevation Strategic Consulting

 

 

Staci Kearney PhD is the founder and CEO of Elevation Strategic Consulting, a firm that provides regulatory assistance to digital pathology companies. In May 2024, the FDA ruled that Laboratory Developed Tests (LDTs) will be regulated as medical devices with FDA oversight in the coming years. Staci joins for a special episode to break down the timeline for vendors to be compliant with the new rule and implications for digital pathology companies and laboratories.

 

[DPA Webinar] Regulatory Changes Unpacked: Expert Insights into the FDA's Oversight of LDTs in Digital Pathology

Laboratory Developed Tests-Frequently Asked Questions-FDA


 

 

Please log in to your DPA profile to submit comments

 

RELATED CONTENT

PODCAST

Zaibo Li, OSUWMC Pathology

Season 2 Episode 14

LISTEN NOW

PODCAST

Harrison Dai, medical student correspondent

Season 1 Episode 15

LISTEN NOW

PODCAST

Harrison Dai, Eastern Virginia Medical School

Season 3 Episode 4

LISTEN NOW
Chat bot