Devyser has achieved a significant regulatory milestone with its first market registration from China’s National Medical Products Administration (NMPA) for Devyser Compact, an IVDR-certified genetic test for detecting fetal chromosomal abnormalities. Rapid prenatal aneuploidy detection kits fall under Class III IVD as part of the NMPA product registration process. This approval enables Devyser to market Devyser Compact as an in vitro diagnostic in China and paves the way for future regulatory approvals in the region for its simple, fast, and accurate genetic testing solutions.

Sysmex Inostics said Tuesday that it has secured New York State Department of Health approval for clinical trial use of the firm's liquid biopsy assay for biomarkers that are relevant for the treatment of multiple cancer types.

The UK Medicines & Healthcare Products Regulatory Agency on Tuesday published a proposed framework for the recognition of in vitro diagnostics that have already been cleared in other jurisdictions.

QuidelOrtho announced Wednesday that it has received approval from Health Canada to market the firm's Triage PLGF test. The test detects a biomarker that can indicate the likelihood of a pregnant person developing preterm preeclampsia.

DiaCarta announced on Tuesday that its over-the-counter fecal occult blood test has received 510(k) clearance from the US Food and Drug Administration.

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.