FDA Approval for Cervical Cancer Device

The U.S. Food and Drug Administration approved Mobile ODT’s EVA (Enhanced Visual Assessment) System for marketing and sale in the United States. The tragedy of cervical cancer – strongly addressed in major urban areas – still plagues much of America, where it is increasingly difficult for a woman to get a timely appointment with an expert gynecologist. Rural residents, specifically, disproportionately bear the burden of the 12,000 cases of cervical cancer each year. In part, this is because “approximately half (1,550, 49%) of the 3,143 U.S. counties lacked a singly ob-gyn, and 10.1 million women (8.2% of all women) lived in those predominantly rural counties.” The approval of the EVA System will now make available a powerful toolkit for rural health providers, and health providers in low resource settings across the country. Using the EVA System, health providers will be able to leverage the cost-effective, internet connected power of a robust video colposcope to serve every woman, everywhere.