January 2024—BD announced it has received FDA 510(k) clearances for its BD MiniDraw, a novel blood collection device that obtains blood samples from a fingerstick. The clearances include low-volume blood collection for a lipid panel, selected chemistry tests, and hemoglobin and hematocrit testing.
Read More »BD launches next-gen blood draw technology
December 2023—BD launched its FDA 510(k)–cleared Pivo Pro needle-free blood collection device, which is compatible with integrated and long peripheral IV catheters, including the Nexiva closed IV catheter system with NearPort IV Access. This expands current Pivo compatibility with short peripheral IV catheters.
Read More »FDA clears respiratory viral panel for BD Max
September 2023—BD announced FDA 510(k) clearance for its BD Respiratory Viral Panel for the BD Max system. It is a single molecular diagnostic combination test that uses a single nasal or nasopharyngeal swab sample to determine if a patient has SARS-CoV-2, influenza A, influenza B, or respiratory syncytial virus. Results are available in about two hours.
Read More »FDA clears respiratory viral panel for BD Max
Aug. 1, 2023—BD announced FDA 510(k) clearance of its BD Respiratory Viral Panel for the BD Max system.
Read More »BD launches FacsDuet Premium system
July 2023—BD announced the worldwide commercial launch of its BD FacsDuet Premium system. The automated instrument prepares samples for in vitro diagnostic and user-defined tests, including cocktailing, washing, and centrifuging, and then automatically transfers samples to the integrated BD FacsLyric clinical flow cytometry system, enabling a walkaway workflow solution.
Read More »BD gets clearance for MRSA diagnostics AI software
June 2023—BD received FDA 510(k) clearance for the BD Kiestra methicillin-resistant Staphylococcus aureus imaging application, which uses artificial intelligence to automate the task of inspecting Petri dishes to determine if there is bacterial growth. The application can evaluate single specimens or group together a large volume of plates with nonsignificant growth for batch review and release negative results. It uses AI algorithms to look for specific culture characteristics on the BBL Chromagar MRSA II plate. Based on that information and analysis by BD Synapsys informatics, plate images are automatically organized and sorted into meaningful worklists, the company says.
Read More »FDA expands approval of BD Onclarity HPV assay
March 2023—BD announced FDA market approval for the Onclarity HPV assay to be used with the Hologic ThinPrep Pap test. The Onclarity HPV assay detects and identifies 14 high-risk human papillomavirus types in a single analysis. The assay reports genotypes 16, 18, 31, 45, 51, 52, 33/58, 35/39/68, and 56/59/66, and has FDA approval for use in vaccinated women.
Read More »BD gets FDA 510(k) clearance for vaginal panel on BD Cor system
March 16, 2023—BD announced it has received FDA 510(k) clearance for its BD Vaginal Panel on the BD Cor system.
Read More »BD introduces robotic track system for microbiology labs
February 2023—BD has introduced a robotic track system for the BD Kiestra microbiology laboratory solution that automates lab specimen processing. The BD Kiestra third-generation total lab automation system allows laboratories to create a custom and flexible total lab automation configuration to connect multiple BD Kiestra modules.
Read More »FDA expands approval of BD Onclarity HPV assay
Feb. 21, 2023—BD announced FDA market approval for the Onclarity HPV assay to be used with the Hologic ThinPrep Pap test.
Read More »BD, Accelerate announce collaboration for antimicrobial ID Dx
September 2022—BD and Accelerate Diagnostics announced a worldwide commercial collaboration agreement in which BD will offer Accelerate’s rapid testing solution for antibiotic resistance and susceptibility. Under the agreement, BD will market and sell the Accelerate Pheno system and Accelerate Arc module and associated test kits through its worldwide sales network in territories where products have regulatory approval or registration.
Read More »BD COVID-19, flu A/B, RSV test gets CE mark
September 2022—BD announced that the BD Max Respiratory Viral Panel, a molecular diagnostic combination test for SARS-CoV-2, influenza A and B, and respiratory syncytial virus, has been CE marked to the IVD directive 98/79/EC. The test uses a single nasal swab or a single nasopharyngeal swab sample to determine if a patient has COVID-19, flu, or RSV.
Read More »BD unveils spectral cell sorter with high-speed imaging technology
August 2022—BD has unveiled its BD FACSDiscover S8 Cell Sorter with BD CellView Image Technology, which captures images of individual cells flowing through the system and sorts them based on detailed microscopic image anaÂlysis of each one at high sort speeds.
Read More »BD, Accelerate announce worldwide commercial collaborationÂ
Aug. 17, 2022—BD and Accelerate Diagnostics announced a worldwide commercial collaboration agreement in which BD will offer Accelerate’s rapid testing solution for antibiotic resistance and susceptibility.
Read More »BD launches infectious disease molecular Dx platform
July 2022—BD announced the U.S. launch of its fully automated, high-throughput infectious disease molecular diagnostics platform, the BD COR MX. The 510(k)-cleared instrument is an analytic option for the modular and scalable BD COR system.
Read More »BD launches infectious disease molecular Dx platform
May 23, 2022—BD announced the U.S. launch of its fully automated, high-throughput infectious disease molecular diagnostics platform, the BD COR MX.
Read More »BD Kiestra IdentifA receives 510(k) clearance
February 2022—BD announced it has received 510(k) clearance from the FDA for the BD Kiestra IdentifA system, which is designed to automate the preparation of microbiology bacterial identification testing. The company says that by automating what are typically cumbersome manual steps, the BD Kiestra IdentifA may reduce the potential for human error when preparing samples for bacterial identification and produce more accurate diagnoses for patients.
Read More »BD launches high-throughput molecular dx platform in U.S.
September 2021—BD has launched its FDA-approved BD COR PX/GX system, a fully automated, high-throughput diagnostic platform that integrates robotics and sample management software algorithms to automate the complete molecular laboratory workflow from sample processing to diagnostic test result.
Read More »FDA authorizes BD COVID-19, flu rapid antigen test
BD announced that the FDA granted emergency use authorization for its rapid antigen test that can detect SARS-CoV-2, influenza A, and influenza B in a single test. The BD Veritor System for Rapid Detection of SARS-CoV-2 & Flu A+B assay takes about 15 minutes to run on the BD Veritor Plus system and distinguishes between SARS-CoV-2, influenza A, and influenza B by providing definitive positive or negative individual digital display readouts for all three. BD plans to launch the test this summer for the 2021–2022 flu season. The test is intended for individuals who are suspected by a health care provider of having COVID-19, flu A, or flu B within six days of symptom onset.
Read More »BD SARS-CoV-2, flu A+B test gets EUA, CE mark
April 2021—BD announced FDA emergency use authorization for its BD SARS-CoV-2/Flu assay, a molecular diagnostic test for SARS-CoV-2 and influenza A and B that provides results in two to three hours. The test also has been CE marked to the IVD directive.
Read More »FDA authorizes BD combination COVID-19, flu rapid antigen test
April 5, 2021—BD announced that the FDA granted emergency use authorization for its rapid antigen test that can detect SARS-CoV-2, influenza A, and influenza B in a single test.
Read More »BD gets EUA, CE mark for combo SARS-CoV-2, flu A+B test
Feb. 19, 2021–BD announced FDA emergency use authorization for a molecular diagnostic test for SARS-CoV-2 and influenza A and B that can return results in two to three hours. The test also has been CE marked to the IVD directive.
Read More »SARS-CoV-2 assay for BD Veritor Plus gets CE mark
December 2020—BD announced its rapid, point-of-care, SARS-CoV-2 antigen test for use on the BD Veritor Plus system has been CE marked to the IVD directive. The test delivers results in 15 minutes and has been authorized by the FDA under an EUA for use by authorized laboratories.
Read More »BD launches POC SARS-CoV-2 antigen test
August 2020—Becton Dickinson announced that the FDA granted emergency use authorization to the BD Veritor Plus System for Rapid Detection of SARS-CoV-2 Assay, a point-of-care diagnostic test for use with the BD Veritor Plus System.
Read More »FDA approves expanded version of BD HPV assay
July 28, 2020—Becton Dickinson received approval for a premarket approval supplement from the FDA for an expanded version of its BD Onclarity HPV Assay.
Read More »BD launches point-of-care SARS-CoV-2 antigen test
July 7, 2020—Becton Dickinson announced that the FDA granted emergency use authorization to the BD Veritor Plus System for Rapid Detection of SARS-CoV-2 Assay, a rapid, point-of-care, diagnostic test for use with the BD Veritor Plus System.
Read More »BD Kiestra ReadA device listed with the FDA
May 2020—BD announced that its BD Kiestra ReadA is device listed with the FDA. The BD Kiestra ReadA incubation and imaging system, which is available as a standalone instrument, aims to help improve operational efficiency in clinical microbiology laboratories by automating routine plate management tasks and delivering accuracy through standardized digital image acquisition.
Read More »BD, Babson to enable blood collection in retail settings
April 2020—Becton Dickinson and Babson Diagnostics, a diagnostic blood testing company, announced a long-term strategic partnership agreement to bring laboratory-quality, small-volume blood collection to retail pharmacies. BD’s capillary specimen collection devices, in development, are designed to enable the collection of laboratory-quality specimens without the need to access a vein and are for use in health care settings without a trained phlebotomist, such as retail pharmacies, physician offices, urgent care centers, and skilled nursing facilities. Babson’s offerings include proprietary automated sample handling and analytical technologies, which are also in development.
Read More »BD gets second FDA EUA, CE mark for COVID-19 dx
April 13, 2020—BD announced that the FDA has granted emergency use authorization for a molecular diagnostic test for COVID-19 that can return results in two to three hours. The test also has been CE marked to the IVD directive.
Read More »BD, BioGX announce FDA EUA for COVID-19 dx
April 3, 2020—BD and BioGX announced that the FDA has granted emergency use authorization for a diagnostic test that will enable hospitals to screen for COVID-19 on site and get results in less than three hours.
Read More »BD, BioMedomics launch POC test to detect COVID-19
April 2, 2020—BD and BioMedomics, a privately held, North Carolina–based clinical diagnostics company, announced the release of a point-of-care test that can detect, in as few as 15 minutes, antibodies in blood to confirm current or past exposure to COVID-19.
Read More »BD, BioGX announce EUA submissions for COVID-19 dx
March 18, 2020—BD and BioGX have submitted emergency use authorization requests to the FDA for new diagnostic tests that, if authorized, would increase the potential capacity to screen for COVID-19 by thousands of tests per day. The tests will be run on the BD Max molecular diagnostic platform, which can process 24 samples simultaneously.
Read More »BD, Babson partner to enable blood collection in retail settings
Feb. 14, 2020—Becton Dickinson and Babson Diagnostics, a diagnostic blood testing company, announced a long-term strategic partnership agreement to bring laboratory-quality, small-volume blood collection to retail pharmacies.
Read More »BD COR now CE-IVD marked
August 2019—BD announced the EU launch of its CE-IVD-marked BD COR, an automated, high-throughput molecular diagnostics system developed for large-capacity laboratories.
Read More »BD FacsDuet system gains CE-IVD certification
May 2019—BD announced CE-IVD certification for its BD FacsDuet automated flow cytometry system. The fully automated sample preparation instrument aims to reduce errors and limit the manual user interactions required to run assays on the BD FacsLyric clinical flow cytometer.
Read More »BD Bactec platelet QC media FDA-cleared, CE-IVD marked
April 29, 2019—BD announced the worldwide availability of BD Bactec platelet quality control media to identify contaminated platelet units. The product can be used for quality control testing of leukocyte reduced apheresis platelet units—leukocyte reduced single and a pool of up to six units of leukocyte reduced whole blood platelet concentrates.
Read More »FDA clears BD Phoenix CPO test
March 2019—BD announced that its BD Phoenix CPO detect test to identify infections caused by carbapenemase-producing organisms has received 510(k) clearance by the Food and Drug Administration.
Read More »BD Max enteric panel gets FDA clearance
March 2019—BD announced FDA 510(k) clearance of its BD Max enteric viral panel, a molecular diagnostic test for the direct qualitative detection and differentiation of enteric viral pathogens that cause viral gastroenteritis.
Read More »BD Max enteric panel gets FDA clearance
Jan. 11, 2019—BD announced FDA 510(k) clearance of its BD Max enteric viral panel, a molecular diagnostic test for the direct qualitative detection and differentiation of enteric viral pathogens that cause viral gastroenteritis. The panel is designed for targeted detection of the viral cause of infectious diarrhea symptoms and can detect norovirus, rotavirus, adenovirus, human astrovirus, and sapovirus. “We continue ...
Read More »BD unveils informatics, automation solutions at ECCMID
July 2018—Becton Dickinson introduced several informatics and automation solutions for clinical laboratories at the European Congress of Clinical Microbiology and Infectious Diseases in Madrid, in April.
Read More »BD launches ccfDNA blood collection tube in Europe
June 2018—Becton Dickinson announced the commercial availability of the CE-IVD-marked PAXgene Blood ccfDNA tube within the European Economic Area and Switzerland.
Read More »CPO assay gets CE mark, 3/18
March 2018—Becton Dickinson and Check-Points obtained the CE mark for a next-generation molecular screening test for antibiotic-resistant carbapenemase-producing organisms on the BD Max System.
Read More »BD HPV assay gets premarket approval
March 8, 2018—Becton Dickinson received premarket approval from the FDA for the BD Onclarity HPV assay. The test detects 14 types of high-risk human papillomavirus from specimens collected for cervical cancer screening in the BD SurePath liquid based cytology vial. The assay also identifies HPV genotypes 16, 18, and 45, which are associated with the majority of cervical cancers and ...
Read More »FDA 510(k) clearance for BD FACSVia, 7/17
July 2017—Becton Dickinson received 510(k) clearance from the FDA for its BD FACSVia, a flow cytometer system with a leucocount reagent assay used in residual white blood cell enumeration.
Read More »BD Veritor meets new FDA flu requirements, 5/17
May 2017—Becton Dickinson announced that its BD Veritor System Flu A+B, a digital immunoassay for the rapid detection of influenza, meets the new FDA performance requirements in which antigen-based rapid influenza virus antigen detection systems (RIDTs) intended to detect influenza virus directly from clinical specimens have been reclassified from class I deÂvices to class II devices subject to special controls.
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