Data from Pharmawand - Curated by EPG Health - Date added 06 December 2017
Merck KGaA, a leading science and technology company, announced the FDA 510(K) clearance of the benchtop embryo incubator Geri. This innovative technology, designed to improve processes in fertility laboratories, will be commercially available to IVF clinics in the U.S. in the first half of 2018.
With the FDA 510(K) clearance of Geri, an incubator for continuous embryo monitoring, Merck will help to advance assisted reproductive treatment (ART) technologies by offering new, relevant solutions to patients and their healthcare professionals. An incubator is critical for embryo development while it is being cultured outside of the uterus. Getting as close as possible to in-vivo incubation conditions is essential to ensure the most favorable environment for embryonic development, given that exposure to non-optimal conditions outside of an incubator may affect the viability and quality of embryos. Geri was designed by embryologists who know the lab processes and what optimizes successful embryo growth. Geri has six individual chambers, each independently controlled, facilitating the care of the embryos of six patients at the same time. It is equipped with high-definition cameras to take a picture of the embryos every 5 minutes and provide continuous imaging so the supervising embryologist can observe embryos as they develop without removing them from their optimum environment. This minimizes lid openings andpotential disruptions that can cause stress to embryos.
With the exception of Australia, Geri is distributed by Merck through its Fertility Technologies unit, in accordance with a global distribution agreement executed with Genea Biomedx in May 2015. Additional products in the Fertility Technologies portfolio of EMD Serono, the biopharmaceutical business of Merck in the U.S. and Canada, include Gems, culture media allowing for high-quality embryo cultivation that was granted an FDA 510(k) clearance this summer, and Gidget a hand-held witnessing system that provides electronic witnessing, visual lab workflow management and support for traceability and audit reporting. .