According to Waters, the FXI system can reduce mean time to detection of bloodstream infections and sepsis by three hours compared to the previous generation FX system.

According to Waters, the FXI system can reduce mean time to detection of bloodstream infections and sepsis by three hours compared to the previous generation FX system.

Waters Corporation's BD BACTEC FXI Culture System is FDA-cleared, allowing faster blood infection diagnostics with superior automation and efficiency.

Waters Corporation's BD BACTEC FXI Culture System, recently FDA-cleared, enhances bloodstream infection diagnostics with faster detection times and increased capacity.

Reported Wednesday, Jun 3 - 8:01am EDT (TheFly subscription required to read more.)

FDA 510(k)-cleared BD BACTEC™ FXI Culture System now available to U.S. market, enabling broader access to confident bloodstream infection diagnostics. Achieves a 3-hour faster time to detection (~15% reduction) versus the prior-generation system, per clinical study data, enabling earlier...

Waters (NYSE: WAT) announced FDA 510(k) clearance for the BD BACTEC FXI Culture System, enabling U.S. commercialization for bloodstream infection and sepsis diagnostics. Clinical data showed a ~3-hour (~15%) faster mean time to detection versus the prior BD BACTEC FX system.The fully automated platform offers automated gravimetric vial volume measurement, up to 60-vial automated loading (50% more than the leading competitor), and 480- or 960-vial configurations. The system is also available in Europe and Japan following CE marking and PMDA licensing.

Bacteria belonging to the species Campylobacter are the most common cause of bacterial diarrhoea in humans. The clinical phenotype associated with Campylobacter infections ranges from asymptomatic con...

With the mark, the system, a fully automated blood culture platform meant for diagnosing bloodstream infections, can be sold throughout the EU.

Waters Corporation's BD BACTEC FXI Culture System receives CE marking, enhancing diagnostics for bloodstream infections with faster detection and automated features.

Achieves a ~3‑hour faster time to detection (~15% reduction) versus the prior generation system, per clinical study data,¹ enabling earlier targeted therapy. First‑of‑its‑kind blood volume measurement objectively confirms sample collection quality in every bottle processed, improving...

Clinician perspectives of the impact of the 2024 National Blood Culture Bottle Shortage on Clinical Care: results of an Emerging Infection Network (EIN) online poll - Volume 5 Issue 1

A shortage of BD BACTECTM blood culture bottles occurred in 2024. We describe the clinical impact of that shortage.MethodsWe conducted a National Healthcare Safety Network (NHSN) questionnaire and retrospective cohort study using inpatient hospitalization data from the Premier Healthcare Database. In the retrospective cohort, facilities were categorized into BD BACTEC™ (n = 11) and non-BD BACTEC™ (n = 28) hospitals; non-shortage and shortage periods were considered from May 2023 to June 2024 and July to November 2024. We used a generalized linear model for the rate of blood cultures with an offset for patient days and adjusted for facility characteristics and other factors. Similarly, we modeled the rate of unique adult hospitalizations with a pathogen-positive blood culture per hospitalization.ResultsOf 3196 facilities responding, 1453 (45.6%) indicated a use of BD BACTECTM to the NHSN questionnaire; of those, 1103 (75.8%) reported a shortage impact. In the retrospective cohort study, there was a 27.4% decrease in cultures at BD BACTEC™ hospitals during the shortage period (95% CI: −31.2% to −23.4%). BD BACTEC™ facilities had a median change in culturing rate of −33.3% (IQR: −47.0% to 2.0%) between the non-shortage and shortage periods. There was a 15.3% decrease in the rate of patients positive for a pathogen at affected facilities during the shortage (95% CI: −22.4% to −7.5%).ConclusionsBD BACTEC™ facilities experienced substantial and non-uniform decreases in blood culture rates. Impacted facilities had a decrease in the rate of observed bloodstream infections, which has implications for patient safety and surveillance.