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Merck KGaA, Darmstadt, recently 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 KGaA, Darmstadt, Germany 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 KGaA, Darmstadt, Germany’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.”
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[TM] 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 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 KGaA, Darmstadt, Germany through its Fertility Technologies unit, in accordance witha 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 KGaA, Darmstadt, Germany, 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.
1. Zhang et al. Reproductive BioMedicine Online (2010) 20, 510-515
2. Swain, J.E., Decisions for the IVF laboratory: comparative analysis of embryo culture incubators, Reproductive BioMedicine Online (2014), doi: http://dx.doi.org/10.1016/j.rbmo.2014.01.004
3. Bontekoe S, Cochrane Database of Systematic Reviews 2012, Issue 7
4. Kirkegaard, K.et al. Fertility and sterility 99.3 (2013): 738-744
For Further Information
More on the gynecological device market in US can be found in a series of reports published by iData Research entitled the US Market Report Suite for Gynecological Devices. The suite covers reports on the following markets: assisted reproduction devices, endometrial ablation, endometrial resection, uterine fibroid embolization, hysteroscopes, colposcopes, transcervical female sterilization, female urinary incontinence slings, laser technology, fluid management equipment, pelvic organ prolapse repair devices and hysterosalpingography catheters.
The iData report series on gynecological devices covers the U.S., Asia-Pacific and 15 countries in Europe including Austria, Belgium, Denmark, Finland, France, Germany, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Reports provide a comprehensive analysis including units sold, procedure numbers, market value, forecasts, as well as detailed competitive market shares and analysis of major players’ success strategies in each market and segment. To find out more about gynecological market data or procedure data, register online or email us at firstname.lastname@example.org for a US Market Report Suite for Gynecological Devices brochure and synopsis.