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Masimo Receives FDA 510(k) Clearance for AI-Enabled Opioid-Induced Respiratory Depression (OIRD) Detection on Radius VSM® to Help Identify Respiratory Risk Sooner
2026-06-24
Original from: Masimo Masimo, a Danaher company and a specialty diagnostics solutions innovator of pulse oximetry and other patient monitoring solutions, today announced FDA 510(k) clearance for an opioi..
Sanofi, Pangaea ink AI partnership deal to detect underdiagnosed genetic disease
2026-06-23
Original from: Fierce Biotech French biopharma Sanofi has inked a partnership deal with Pangaea Data to use its AI platform that helps detect Alpha-1 Antitrypsin Deficiency (AATD), which will be distribu..
IVD China last week: Snibe, BGI, Dirui, Fosun Adgenvax
2026-06-22
Snibe's Clinical Chemistry Analysis System Receives CDC Certification On June 16, the Total Glycerides (TG) assay on Snibe's clinical chemistry analysis system successfully passed the CDC-CRMLN certifica..
Co-Diagnostics Hosts Kingdom of Saudi Arabia Joint Venture CoMira for Unveiling of Future Automated Manufacturing Line
2026-06-22
Original from: PR Newswire Co-Diagnostics, Inc. (Nasdaq: CODX) ("Co-Dx" or "the Company"), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tes..
DiaSorin Announces FDA 510(k) Clearance and CLIA Waiver for the LIAISON NES Group A Streptococcus (GAS) Assay
2026-06-22
Original from: DiaSorin Diasorin (FTSE MIB: DIA) announced today that it has received 510(k) clearance and CLIA waiver from the U.S. Food and Drug Administration (FDA) for its Group A Streptococcus (GAS)..
In Vitro Diagnostic Industry in China - Blood Typing Instruments and Reagents XV
2026-06-17
4.3 Market Conditions of Blood Typing Reagents 4.3.1 Market Size of China’s Blood Typing Reagent between 2024 and 2025 According to the network statistics, market size of China’s blood group reag..
Nivi, Inc. and MSD Collaborate to Expand HPV Disease Awareness and Cervical Cancer Prevention Through AI-Powered Platform
2026-06-17
Original from: PR Newswire Nivi, Inc., a digital health innovator specializing in personalized healthcare guidance and consumer insights, and MSD (known as Merck Sharp & Dohme LLC in the United State..
Roche receives FDA approval for the first companion diagnostic to assess PTEN protein in people living with prostate cancer
2026-06-16
Original from: Roche Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today that the VENTANAⓇ PTEN (SP218) RxDx Assay is the first immunohistochemistry (IHC) companion diagnostic test to receive U.S. F..
Cepheid Delivers Xpert® Hemorrhagic Fever Panel Tests to Africa to Address Diagnostic Gaps in Ebola Bundibugyo Outbreak
2026-06-15
Original from: business wire Cepheid, a Danaher company, today announced it has donated an initial shipment of Xpert® Hemorrhagic Fever panel tests to support the diagnostic response to the Ebola Bun..
Roche’s VENTANA MMR RxDx Panel CDx receives IVDR approval across multiple cancer types and therapies
2026-06-12
Original from: Roche Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today the European Union In Vitro Diagnostic Regulation (IVDR) approval of several label expansions for the VENTANA® MMR RxDx Panel, ..
Guardant Health Announces FDA Approval of Guardant360 CDx as Companion Diagnostic for Boehringer Ingelheim’s HERNEXEOS®
2026-06-12
Original from: Guardant Health Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced that the U.S. Food and Drug Administration (FDA) has approved Guardant360® CDx..
Danaher Completes Acquisition of Masimo Corporation
2026-06-10
Original from: Danaher Danaher Corporation (NYSE: DHR), a global science and technology innovator, announced today that it has completed the acquisition of Masimo Corporation, a leading specialty diagnos..
Burning Rock Reports First Quarter 2026 Financial Results
2026-06-10
Original from: GlobeNewswire Burning Rock Biotech Limited (NASDAQ: BNR, the “Company” or “Burning Rock”), a company focused on the application of next-generation sequencing (NGS) technology in the fi..
Personalis Enables Global Biopharma Support with CE-IVD Marked Specimen Collection Kits
2026-06-10
Original from: businesswire Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, today announced that its Personalis EDTA Blood Collection Kit and Personalis cfDNA Blood..
In Vitro Diagnostic Industry in China - Blood Typing Instruments and Reagents XIV
2026-06-09
4.2.2 Development Trend of Blood Typing Reagent Technologies It can be seen from analysis on major Blood typing reagents-related patent applications published in the 3 years between 2018 and 2021 that directions..
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