Revvity and Danaher subsidiary Sciex said Tuesday that they have signed a distribution agreement that will improve the accuracy of mass spectrometry-based disease screening in newborns by combining Sciex's mass spectrometry instruments and Revvity's reagents.

Abbott (NYSE: ABT) today announced financial results for the third quarter ended Sept. 30, 2023.

As of October 12, 2023, a total of 231 breakthrough medical devices have been approved in China, including 24 IVD products.

Werfen has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Aptiva Connective Tissue Disease (CTD) Essential reagent.

Thermo Fisher Scientific Inc. (NYSE: TMO) (“Thermo Fisher”), the world leader in serving science, and Olink Holding AB (publ) (“Olink”) (Nasdaq: OLK), a leading provider of next-generation proteomics solutions, today announced that their respective boards of directors have approved Thermo Fisher’s proposal to acquire Olink for $26.00 per common share in cash, representing $26.00 per American Depositary Share (ADS) in cash.

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

EliTechGroup announced on Thursday that it has received certification under Europe's In Vitro Diagnostic Regulations for multiple infectious disease tests.

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.

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

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.

BioMérieux announced on Friday that it has obtained CE marking for an assay to detect two biomarkers associated with mild traumatic brain injury (mTBI).

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.

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.

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.

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.