Heather Rone

Biography

 Heather is an acknowledged clinical and regulatory professional with a highly successful record of first-ever accomplishments within the medical technology domain. During her nearly seven-year tenure at U-Systems. she was responsible for the development and implementation of a comprehensive global training program for the automated breast ultrasound product line, satisfying new FDA training mandates that became a model for the industry. She directed multiple prospective clinical trials in the U.S. and Europe, enrolling over 18,000 participants. This extraordinary effort and achievement culminated in the first-ever FDA approval for a breast ultrasound screening indication. Among her many firsts, she was instrumental in earning additional regulatory approvals in the U.S. and global markets. Heather has co-authored multiple publications and her research efforts have contributed to several published manuscripts in peer-reviewed journals.

Research Interest

 clinical and regulatory