Female focused medical device development

Historically, biomedical research—from non-clinical cell research to  animal studies to clinical human research—has overwhelmingly been  conducted in patients assigned as male at birth. In 2016, the CDRH initiated the Health of Women Program to address the  steadily growing importance of sex- and gender-specific issues arising  from medical technology design and development, clinical trial design  and other medical device-related matters. Since its start, the program  has been working toward a better understanding of how medical  devices—those developed specifically for women as well as those  developed for people of all sexes and genders—perform in women and  exploring unique issues in the regulation of medical devices related to  the health of women.  With that new support from CDRH, GYN Logic is in early development of surgical devices focused on solving the current problems with pelvic prolapse and stress urinary incontinence.  INVESTIGATIONAL AND NOT AVAILABLE FOR COMMERCIAL SALE.