This well-funded startup relies on iMerit for regulatory-grade data sourcing, HIPAA-compliant data management, expert 3D radiological segmentation, and FDA benchmarking.

iMerit sourced the images, labeled it scalably, guided us towards the critical validation we needed, and helped us launch on time.

CTO

Problem 

This MedTech startup struggled to source radiological imagery while still maintaining FDA 510(k) compliance.

Solution

iMerit’s data curation teams sourced CT and MRI scans via its network of healthcare providers and ensured all data was annotated to satisfy regulatory requirements.

Results

iMerit guided this startup to successful FDA approval while reducing project cost by 72%.

 

BOTTOM LINE IMPACT

99%

Annotation Quality

72%

Cost Savings

FDA

Approval Granted