US Food and Drug Administration officials on Wednesday released draft guidance outlining the types of predicate device analysis and evidence they will expect in 510(k) clearance applications as they work to modernize the clearance process for medical devices, including in vitro diagnostics.

LabGenomics USA, a subsidiary of South Korean-based diagnostics firm LabGenomics, said Tuesday that it has acquired QDx Pathology for an undisclosed amount.

Abbott (NYSE: ABT) and Bigfoot Biomedical today announced a definitive agreement for Abbott to acquire Bigfoot, a leader in developing smart insulin management systems for people with diabetes.

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

Centogene finds diagnostic and predictive biomarker for Gaucher disease.

In a recent study published in The Journal of Applied Laboratory Medicine, researchers evaluated the performance of a compact diagnostic assay that can accurately and rapidly diagnose lactose intolerance using capillary blood and buccal swab samples.

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

Oxford Nanopore Technologies and IQVIA have struck a partnership to broaden access to nanopore sequencing technology, saying it will boost genomics research and patient care.

BioMérieux reported on Friday that its second quarter 2023 revenues increased 5 percent driven by strong momentum in microbiology, its BioFire non-respiratory panel, and industrial applications.

Burning Rock Biotech Limited (NASDAQ: BNR and LSE: BNR, the “Company” or “Burning Rock”), a company focused on the application of next generation sequencing (NGS) technology in the field of precision oncology, today reported financial results for the three months ended June 30, 2023.

MHRA automatically moved the U.K.’s three existing notified bodies, BSI, SGS and UL, to the approved body scheme when the country split from the European Union. Since then, efforts to add capacity have proceeded slowly. The U.K. affiliate of DEKRA, a notified body in the EU, became the first new approved body for medical devices 11 months ago.

An international team of researchers has developed a PCR-based assay to detect mitochondrial DNA (mtDNA) damage in blood, an indicator of Parkinson's disease. The test may help diagnose the condition before the nervous system of patients is excessively damaged, they said, and could be used to measure response to certain drugs in development to treat the disease.

Quest Diagnostics (NYSE: DGX), the nation's leading provider of diagnostic information services, today announced that its AAVrh74 ELISA assay (CDx) has been granted Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA).

On August 13th, China's State Council issued a 24-point guideline covering six areas.

Ginkgo Bioworks said Tuesday that it has formed a five-year partnership with Google Cloud to develop large language models for genomics, protein function, and synthetic biology. The companies hope that the collaboration will support cell programming and biosecurity to help advance fields including drug discovery, agriculture, and industrial manufacturing.

VC investment in medtech fell across 2022, and the downward trend in deal value continued in the first quarter of 2023. The second quarter brought potential signs that a recovery is starting. Deal value ticked up from $2.5 billion to $2.8 billion between the first and second quarters, and the number of deals rose from 183 to 189.

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

By studying cell-free DNA methylation (cfDNAme) patterns among pregnant women, researchers in Belgium have developed a liquid biopsy screening test to identify women at risk of early-onset preeclampsia (PE).

Medical tool supplier Danaher (DHR) is expanding its product offerings by purchasing British biotech firm Abcam Plc (ABCM) for $5.7 billion, including debt.

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