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

Roche announced on Monday that its hepatitis B immunoassay has received CE marking and is available for use in countries accepting the regulatory designation.

U.K. medical regulators have approved a “world-first” gene therapy that aims to cure two blood disorders: sickle cell disease (SCD) and transfusion-dependent β-thalassemia. They are the first regulatory body to approve the treatment.

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

Thermo Fisher Scientific said on Thursday that its Exent Solution, an automated mass spectrometry system for diagnosing patients with monoclonal gammopathies, including multiple myeloma, has been approved under Europe's In Vitro Diagnostics Regulation.

Recently, Ustar and Hangzhou Biotest Biotech received the IVDR CE certificate from TÜV SÜD, a notified body designated under the EU's IVDR.

On July 10, 2023, NMPA released information on the delivery of medical device approval certification documents.

On July 5th, the State Council Information Office held a series of press conferences covering the review and approval of medical devices, medical device regulation, innovative medical devices and other industry issues of concern.

Roche announced on Monday that its Ventana PD-L1 (SP263) assay has received approval from the US Food and Drug Administration for use as a companion diagnostic with Regeneron's Libtayo (cemiplimab) in lung cancer patients.

BGI Genomics said on Friday that its multiplexed test for SARS-CoV-2, influenza A, and influenza B is now included in the Australian Register of Therapeutic Goods.