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).

Laboratory services provider Stone Diagnostics will offer Fibronostics' artificial intelligence-based liver disease test to physicians in the US, the companies announced on Tuesday.

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.

China Association of In Vitro Diagnostics (CAIVD) and In Vitro Diagnostics Society of China Association for Medical Devices Industry jointly compiled this report.

Invitae (NYSE: NVTA), a leading medical genetics company, today announced it gained FDA market authorization for its Common Hereditary Cancers Panel.

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.

Stay up-to-date with the latest happenings in the rapidly evolving field of In Vitro Diagnostics (IVD) in China.

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.

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.

China Association of In Vitro Diagnostics (CAIVD) and In Vitro Diagnostics Society of China Association for Medical Devices Industry jointly compiled this report.

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.

Thermo Fisher Scientific said on Wednesday that it has obtained US Food and Drug Administration clearance for its BRAHMS CgA II KRYPTOR test, a chromogranin A (CgA) immunoassay for assessing tumor progression in gastroenteropancreatic neuroendocrine tumor (GEP-NET) patients.

In 2023, NHC and 10 other departments issued the Action Plan Towards the Elimination of Cervical Cancer (2023-2030). The goal is that by 2025, HPV vaccination services for girls of school age will be promoted on a pilot basis, the cervical cancer screening rate for women of school age will reach 50%, and the treatment rate for patients with cervical cancer and precancerous lesions will reach 90%.

Cell Signaling Technology (CST), a life science discovery technology company and leading provider of antibodies, kits, and services, is partnered with Leica Biosystems, a technology leader in automated staining and brightfield and fluorescent imaging, to support the development of companion diagnostics (CDx) assays using the extensive portfolio of best-in-class antibodies from CST validated for immunohistochemistry (IHC).

Through MDUFA V, the FDA committed to several international harmonization initiatives and secured additional resources to support the work. The publication of a draft strategic plan was the first item on the MDUFA V convergence and reliance agenda.