FDA OKs Molecular Diagnostics' Pap collector:
This article was originally published in Clinica
Executive Summary
Molecular Diagnostics has received US FDA 510(k) clearance to market its InPath e2 Collector, a cervical sampling device that can collect cells for Pap test analysis in a single step. The device consists of a silicone balloon that is shaped like the cervix. When inflated, cells adhere to the balloon's surface, reducing trauma to the cervix that can occur using traditional Pap test collection methods that require scraping cells from two parts of the cervix in separate steps, says the Chicago, Illinois firm.