QuidelOrtho Corporation, a global provider of innovative in vitro diagnostic technologies designed for point-of-care settings, clinical labs and transfusion medicine, announced today that it has been granted a De Novo request from the U.S. Food and Drug Administration (FDA).

Recently, executives from multinational medical enterprises intensively visited China or revealed their plans to visit China. It is becoming a common question for most multinational medical businesses to explore how to support China's high-level opening up.

Spectrum Solutions® announced the acquisitions of Alimetrix, Inc., a CLIA and CAP accredited molecular diagnostic laboratory, and Microarrays, Inc., a leader in customer array-based products that are used as biological research tools.

Abbott announced on Tuesday that its laboratory-based test for traumatic brain injuries has received clearance from the US Food and Drug Administration.

TinkerBio completed a Series A+ financing round of tens of millions of RMB, exclusively invested by Panlin Capital.

MGI Tech said last week that it has signed the EU Declaration of Conformity for its DNBSeq-G99 sequencer, granting the instrument CE marking under Europe's new In Vitro Diagnostic Regulation (IVDR).

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.

Recently, U.S. Food and Drug Administration (FDA) and China National Medical Products Administration (NMPA) have released their summaries on medical device innovation in 2022.

The US Food and Drug Administration has allowed InBios International to market its point-of-care anthrax test, the firm announced this week.

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.

Recently, Sansure and Singlera jointly established Jiangsu Yang Shengyuan Biotechnology Co., Ltd. with the registered capital of 10 million CNY at Yangzhou City.

Illumina and Myriad Genetics said on Thursday that they have expanded their strategic partnership on homologous recombination deficiency (HRD) testing.

Biocartis said Thursday that it has secured US Food and Drug Administration 510(k) clearance for a microsatellite instability (MSI) assay to screen for Lynch syndrome in colorectal cancer patients.

By the end of 2022, there were 1,033,000 medical and health institutions in China, including 37,000 hospitals. The medical and health institutions in China possessed 9.75 million beds, of which hospitals possessed 7.66 million and township health centers had 1.45 million.

QIAGEN N.V. announced the launch of the new QIAseq Platform Partnership program and the first partnership with medical data-analysis provider SOPHiA GENETICSTM that will bring together its QIAseq reagent technology for next-generation sequencing with the SOPHiA DDMTM digital analytics platform.