China will adjust tariffs on imported U.S. products from 12:01 p.m. Wednesday, the Customs Tariff Commission of the State Council announced on Tuesday.
The immunoassay segment accounts about 35% of the market, with no growth compared to the previous year. Domestic brands account for over 35%.
The Medical Device Coordination Group (MDCG) has published guidance MDCG 2021-21 “Guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices” – the document is critical for all manufacturers who manufacture and have CE marked COVID-19 tests under the IVD Directive (IVDD).
LumiraDx reduced the terms of the valuation for its SPAC merger from $5 billion to$3 billion citing a decline in COVID-19 testing
The US Food and Drug Administration this week granted separate Emergency Use Authorizations for PCR-based SARS-CoV-2 tests developed by Mount Sinai Hospital and Empire City Laboratories.
Genetron Health collaborates with Yikon Genomics, expanding S5 Platform's reach to reproductive health field; AmoyDx collaborates with Amgen to develop companion diagnostics for Japan market; AcornDx collaborates with BGI to develop accurate diagnosis on urinary system tumors
MDxHealth reported Thursday after the close of the Belgian stock exchange that its revenues for the first half of 2021 increased 9 percent year over year.
Thermo Fisher Scientific said on Wednesday that the US Food and Drug Administration has granted pre-market approval to the company's Oncomine Dx Target Test as a companion diagnostic to identify patients with isocitrate dehydrogenase-1 (IDH1) mutated cholangiocarcinoma (CCA)
August 25, Mindray (300760.SZ) announced financial results for the first half ended June 30, 2021. The first-half sales of CNY 12.778 billion increased 20.96% year-on-year. The net earnings attributable to common stockholders was CNY 4.344 billion, increasing 25.79% than the one in the last year.
AccessDx Holdings said Wednesday that it has acquired 2bPrecise, a service and technology provider that integrates genetic and genomic test results into electronic health records, from EHR giant Allscripts Healthcare Solutions for an undisclosed amount.
Becton Dickinson announced Wednesday that it has received US Food and Drug Administration approval for its automated, sample-to-answer, high-throughput BD Cor system along with the BD Onclarity HPV Assay for extended genotyping of human papillomavirus.
On August 20, Fosun Diagnostics, a holding subsidiary of Fosun Pharma, signed the investment agreement with Suzhou Abcarta. After the completion of the transaction, Fosun Diagnostics will hold about 58.67% equity of Suzhou Abcarta.
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