FDA clears Esco Medical’s Miri TL embryo incubator

In vitro fertilization business Esco Medical said today the FDA granted 510(k) clearance to its Miri Time-Lapse embryo incubator. The newly cleared Miri TL is designed as a multi-room incubator with a built-in microscope and camera to continuously capture images of embryo development until the embryo is ready to transfer, the company said. “We are pleased and proud to add Miri TL to the list of 510(k) cleared products. Miri TL provides an extensive list of quality control features such as an extremely reliable gas mixer, HEPA/VOC filter, UV light for airflow sterilization and built-in pH meter. Time-Lapse is an interesting and promising technology for improving IVF success rates. We are looking forward to serving our current and future customers to benefit from observing the dynamics of embryo development,” group CEO XiangQian Lin said in a prepared statement. The Miri TL comes with a built-in gas mixer and 6 chambers with independent temperature control and can be used to simultaneously incubate up to 84 embryos. The device also comes with the Miri TL viewer software to assist in processing generated data, the company said. “Infertility is on the rise as a result of factors such as cultural shifts and aging. In the US alone, approximately 15% of couples are involuntarily infertile. As one of the top ranking medical centers in the US, UCSF has been a firm believer in Esco and its expertise in the IVF segment. Stability during the process of embryo ...
Source: Mass Device - Category: Medical Equipment Authors: Tags: 510(k) Regulatory/Compliance Women's Health Esco Medical Source Type: news

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