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Stay up-to-date with the latest happenings in the rapidly evolving field of In Vitro Diagnostics (IVD) in China.2024-04-23View More
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A team led by researchers at the University of Michigan has developed and clinically validated an 18-gene urinary test for detecting high-grade prostate cancer.2024-04-22View More
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BGI Genomics, a global leader in integrated precision medicine solutions, has established a new clinical laboratory at Uruguay's Parque de las Ciencias free trade zone. This facility is poised to become a regional hub, advancing preventive medicine across Latin America and utilizing advanced technology to facilitate early disease diagnosis.2024-04-22View More
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The market for medical technology is innovative, dynamic, and growing. Bosch sees medical technology as a strategic growth field and intends to expand its Bosch Healthcare Solutions subsidiary, based in Waiblingen.2024-04-19View More
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NanoString Technologies said on Wednesday after the close of the market that Bruker will acquire substantially all of its assets for approximately $392.6 million in cash. In addition, Bruker will assume certain liabilities from NanoString.2024-04-18View More
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Abbott on Wednesday announced that its Q1 2024 Diagnostics revenues declined 18 percent year over year as a result of declining COVID-19 testing sales.2024-04-18View More
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In April, the recent release of the 2024 medical device classification encompasses 223 results, including 93 products related to In Vitro Diagnostics (IVD). Among these, 27 IVD-related products are suggested for Class III medical device management, 45 for Class II, and 14 for Class I.2024-04-17View More
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Johnson & Johnson's (JNJ.N), opens new tab first-quarter revenue missed Wall Street estimates for medical devices on Tuesday and sales of its blockbuster psoriasis drug Stelara came in lower than expected as the company prepares for its loss of exclusivity in the U.S.2024-04-17View More
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Global life sciences company Labcorp has announced the first commercially available glial fibrillary acidic protein (GFAP) blood biomarker test in the US, offering a new tool for the early detection of neurodegenerative diseases and brain injuries.2024-04-17View More
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Biochemical diagnosis is often used for the testing of basic items such as liver function, kidney function, blood glucose, and blood lipid. By measuring the content (activity) of specific biochemical substances, people's physical conditions can be assessed and the relevant causes can be identified.2024-04-16View More
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Prenosis¡¯ Sepsis Immunoscore software analyzes 22 parameters such as respiratory rate and blood pressure to assess the likelihood that a patient will develop sepsis within 24 hours. Companies including Epic Systems, a leading provider of electronic health records, have developed software for assessing sepsis risk, but Prenosis broke new ground with its recent de novo authorization.2024-04-16View More
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Agilent Technologies Inc. (NYSE: A) today announced that its GenetiSure Dx Postnatal Assay has received European IVDR Class C Certification. This certification demonstrates that the assay meets the higher standards established by IVDR. It ensures the continued availability of this trusted qualitative assay to clinical geneticists and other healthcare professionals throughout the EU.2024-04-16View More
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Stay up-to-date with the latest happenings in the rapidly evolving field of In Vitro Diagnostics (IVD) in China.2024-04-15View More
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Oncocyte announced on Thursday that it has partnered with Bio-Rad Laboratories to globally commercialize the research-use-only GraftAssure assay.2024-04-15View More
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Illumina, Inc. (NASDAQ: ILMN), a global leader in DNA sequencing and array-based technologies, today announced it has received approval of its divestment plan for GRAIL from the European Commission (EC).2024-04-15View More
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Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that its Elecsys pTau217 assay received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). This blood test, which is being developed in collaboration with Eli Lilly and Company, will be used to help identify the presence or absence of amyloid pathology in individuals, which can help ensure they are able to receive appropriate care. This may include participation in clinical trials or access to approved disease-modifying therapies. If approved, the test could help rapidly broaden access to a more timely and accurate diagnosis and potentially mitigate the impact of Alzheimer¡¯s disease on people and society.2024-04-12View More
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Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, announced today the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for its Mpox PCR Test Home Collection Kit to aid in the diagnosis of infection with non-variola Orthopoxvirus, including the monkeypox virus that causes monkeypox, also known as mpox. The test is the first mpox at-home collection kit authorized by FDA and is available to physicians to order for patients 18 years of age or older who are suspected of mpox infection.2024-04-11View More
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Bosch has entered into a strategic partnership with the laboratory and medical technology company Randox Laboratories Ltd. The two companies are investing around 150 million euros in joint research, development and sales activities. This will result in new tests for the Vivalytic analysis platform from Bosch Healthcare Solutions. One objective is the development of an IVD (in vitro diagnostics) high multiplex sepsis test, which is to be implemented for the first time on the basis of the innovative BioMEMS technology.2024-04-11View More
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Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the approval of the CE Mark for the VENTANA® HER2 (4B5) Rabbit Monoclonal Primary Antibody RxDx* to identify metastatic breast cancer patients with low HER2 expression for whom ENHERTU® (trastuzumab deruxtecan) may be considered as a targeted treatment. The test, which is branded PATHWAY in the United States, received US Food and Drug Administration (FDA) approval in October 2022. ENHERTU is a specifically engineered HER2-directed antibody drug conjugate (ADC) being jointly developed and commercialised by Daiichi Sankyo and AstraZeneca.2024-04-11View More
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BioM¨¦rieux reported on Tuesday that its first quarter revenues grew approximately 7 percent year over year driven by growth in BioFire and microbiology sales.2024-04-10View More
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