Tag Archives: BD

March 2024—While Dr. Seuss’ assertion that “the more that you read, the more things you will know” is generally accurate, it doesn’t address the fact that how information is presented affects comprehension, a truism that is not lost on Edward Klatt, MD, who knows whereof he speaks when it comes to sharing information on patient portals.

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.

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.

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.

Aug. 1, 2023—BD announced FDA 510(k) clearance of its BD Respiratory Viral Panel for the BD Max 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.

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.  

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.  

March 16, 2023—BD announced it has received FDA 510(k) clearance for its BD Vaginal Panel on the BD Cor system.

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.  

Feb. 21, 2023—BD announced FDA market approval for the Onclarity HPV assay to be used with the Hologic ThinPrep Pap test.

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.

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.

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 ana­lysis of each one at high sort speeds.

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.

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.

May 23, 2022—BD announced the U.S. launch of its fully automated, high-throughput infectious disease molecular diagnostics platform, the BD COR MX.

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.

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.

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.  

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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 ...

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.

June 2018—Becton Dickinson announced the commercial availability of the CE-IVD-marked PAXgene Blood ccfDNA tube within the European Economic Area and Switzerland.

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.

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 ...

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.

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 de­vices to class II devices subject to special controls.