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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Source: the Mail online | Health - Category: Consumer Health News Source Type: news
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Source: Frontiers in Genetics - Category: Genetics & Stem Cells Source Type: research
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Source: Frontiers in Psychiatry - Category: Psychiatry Source Type: research
Condition:   Infertility Intervention:   Other: Serum amyloid A level Sponsor:   Ain Shams Maternity Hospital Completed
Source: ClinicalTrials.gov - Category: Research Source Type: clinical trials
Authors: Esteves SC, Agarwal A, Roque M, Humaidan P Abstract PMID: 30990288 [PubMed - in process]
Source: Panminerva Medica - Category: General Medicine Tags: Panminerva Med Source Type: research
Authors: Lopes LS, Esteves SC Abstract In recent years, growing evidence has challenged the notion that sperm quantity and quality are not essential for the success of assisted reproductive technology. DNA fragmentation assessments on ejaculated and testicular sperm harvested from non-azoospermic infertile men have reported a remarkable decrease in DNA damage in spermatozoa directly retrieved from the seminiferous tubules. Moreover, emerging evidence using molecular genetic techniques indicates that aneuploidy rates are lower in testicular sperm than in ejaculated counterparts. The use of testicular sperm from non-...
Source: Panminerva Medica - Category: General Medicine Tags: Panminerva Med Source Type: research
Authors: Cho CL, Esteves SC, Agarwal A Abstract Varicoceles exert deleterious effect on testicular function. The condition has been associated with male infertility, testicular hypotrophy and pain. These comprises the common indications for varicocele repair currently. Significant improvement in semen parameters and pregnancy outcomes had been suggested by reports decades ago. However, selection of the best candidates remains an issue since not all patients respond positively to treatment. Consensus has been reached in recent decade after the publication of a series of meta-analyses. Significant improvement in preg...
Source: Panminerva Medica - Category: General Medicine Tags: Panminerva Med Source Type: research
Authors: Majzoub A, Agarwal A, Esteves SC Abstract Sperm DNA fragmentation (SDF) is an advanced test of sperm function that is utilized during male fertility evaluation. Recently, a guideline was published highlighting the detrimental impact of SDF on sperm function identifying practice-based clinical indications for SDF testing. This review illustrates the commonly utilized SDF measurement techniques and explores the current evidence behind their utility in clinical practice. Patients diagnosed with varicocele, unexplained infertility, recurrent pregnancy loss, recurrent failure of assisted reproductive techniques...
Source: Panminerva Medica - Category: General Medicine Tags: Panminerva Med Source Type: research
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Source: Panminerva Medica - Category: General Medicine Tags: Panminerva Med Source Type: research
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Source: Panminerva Medica - Category: General Medicine Tags: Panminerva Med Source Type: research
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