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EliTechGroup announced on Thursday that it has received certification under Europe's In Vitro Diagnostic Regulations for multiple infectious disease tests.2023-10-17View More
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Revvity, Inc. and Element Biosciences, Inc., a developer of the AVITI™ System, an innovative and emerging genomic sequencing platform, today announced a collaboration to introduce workflow solutions that save time and effort required for genomic analysis of samples.2023-10-17View 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.2023-10-16View More
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Burning Rock Biotech Limited (NASDAQ: BNR and LSE: BNR, the ¡°Company¡± or ¡°Burning Rock¡±) is pleased to announce that followed an earlier Breakthrough Device Designation granted by the US Food and Drug Administration (FDA) for its OverC™ Multi-Cancer Detection Blood Test (MCDBT) in January 2023, its OverC™ MCDBT has been granted Breakthrough Device Designation by the China National Medical Products Administration(NMPA), which represents the only test globally that has received Breakthrough Device Designation from both US FDA and China NMPA.2023-10-16View More
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BioM¨¦rieux announced on Friday that it has obtained CE marking for an assay to detect two biomarkers associated with mild traumatic brain injury (mTBI).2023-10-16View More
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Roche subsidiary Foundation Medicine announced on Thursday that the US Food and Drug Administration has approved two of its companion diagnostic tests for use with Pfizer's Braftovi (encorafenib) in combination with Mektovi (binimetinib) for patients with metastatic non-small cell lung cancer with a BRAF V600E mutation.2023-10-13View More
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U.S. genetic testing company Illumina (ILMN.O) has been ordered by EU antitrust regulators to sell cancer test maker Grail (GRAL.O) after it completed the deal before securing their approval.2023-10-13View More
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As more and more medical technologies are being built on artificial intelligence and machine learning, the FDA is enlisting a new panel of outside experts to help it get deeper into the weeds.2023-10-12View More
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Labcorp (LH.N) on Wednesday began marketing to U.S. physicians the first test for a trio of blood biomarkers it says can detect the hallmarks of Alzheimer's, accelerating diagnosis of the brain-wasting disease and potentially helping patients access treatment.2023-10-12View More
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As of the end of June 2023, the number of valid registrations and filings of medical devices nationwide reached 301,639, an increase of 18.12% compared with the same period of last year, with 46,283 new cases, an increase of 7.25% compared with the end of 2022 (281,243 cases).2023-10-11View More
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Laboratory services provider Stone Diagnostics will offer Fibronostics' artificial intelligence-based liver disease test to physicians in the US, the companies announced on Tuesday.2023-10-11View More
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Fujirebio Holdings, Inc. (HQ: Minato-ku, Tokyo; President & CEO: Goki Ishikawa) and Sysmex Corporation (HQ: Kobe, Japan; President: Kaoru Asano) announce that they have entered into a Basic Agreement on Business Collaboration to deepen their multifaceted collaboration, such as on research and development, production, clinical development, and sales-marketing, in the field of immunoassay.2023-10-11View More
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China Association of In Vitro Diagnostics (CAIVD) and In Vitro Diagnostics Society of China Association for Medical Devices Industry jointly compiled this report.2023-10-10View More
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Invitae (NYSE: NVTA), a leading medical genetics company, today announced it gained FDA market authorization for its Common Hereditary Cancers Panel.2023-10-10View More
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Foundation Medicine Inc. today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne®CDx to be used as a companion diagnostic for Eli Lilly and Company¡¯s Retevmo (selpercatinib), which was approved by the FDA for the treatment of adult patients with locally advanced or metastatic solid tumors with a RET gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options.2023-10-10View 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.2023-10-09View More
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Agilent Technologies Inc. (NYSE: A) today announced the signing of a Memorandum of Understanding (MOU) with the Sarawak Infectious Disease Centre (SIDC) in East Malaysia.2023-10-09View More
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Today, Sanguina, Inc. (Sanguina), a leading biotech company, is pleased to announce the FDA clearance of AnemoCheck Home, the only FDA-cleared home hemoglobin test kit available in the United States.2023-10-09View More
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China Association of In Vitro Diagnostics (CAIVD) and In Vitro Diagnostics Society of China Association for Medical Devices Industry jointly compiled this report.2023-10-03View More
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Recently, Autobio's hepatitis B virus surface antigen (HBsAg) detection kit (magnetic particle chemiluminescence method) successfully passed the European clinical assessment and obtained the first EU CE IVDR Class D certification in China.2023-09-28View More
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