Monday, 11 December 2017

Merck in collaboration with Genea Biomedx got FDA 510(k) permission for benchtop embryo incubator Geri

06 December 2017 | News

Expanded Fertility Technology portfolio highlights Merck's commitment to improve fertility treatment outcomes for patients

Leading healthcare science and technology company, Merck, 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.

Merck will help to advance assisted reproductive treatment (ART) technologies by offering new, relevant solutions to patients and their healthcare professionals.

"Geri is one of the flagship products of our fertility technologies portfolio and has been successfully used in clinics across Australia, Europe and Asia for the last two years," said Rehan Verjee, Chief Marketing and Strategy Officer at Merck's biopharma business.

"Offering Geri in the U.S. will allow us to further our aspiration of becoming an integrated fertility treatment partner, continuously aiming to improve treatment outcomes." stated Rehan Verjee 

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.

With the help of these images, supervising embryologist can observe embryos as they develop without removing them from their optimum environment.

This minimizes lid openings and potential disruptions that can cause stress to embryos. 

"Genea Biomedx is an IVF medical device company uniquely positioned within a clinical fertility business allowing it direct access to world leading IVF laboratories. This enabled us to develop Geri in collaboration with the embryologists that use it day in, day out," said Dr. Tammie Roy, General Manager at Genea Biomedx. "We are looking forward to working with EMD Serono to bring our innovative technology to clinics across the U.S." 

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.

 

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