MILFORD, Mass. - Waters Corporation (NYSE:WAT) announced today that its BD BACTEC FXI Culture System has received U.S. Food and Drug Administration 510(k) clearance, according to a press release statement.
The system is designed to detect bloodstream infections and sepsis in microbiology laboratories. Clinical study data showed the system reduced mean time to detection by approximately three hours compared to the previous-generation BD BACTEC FX Blood Culture System, with detection times of 17 hours versus 20 hours.
The fully automated system can load up to 60 vials at a time and offers configurations of 480 or 960 vials per module. The system automates vial loading, unloading, incubation and detection alerts.
The BD BACTEC FXI Culture System includes automated gravimetric measurement of blood culture vial volume, which the company states confirms blood volume in each vial.
"Waters is proud to bring the BD BACTEC FXI Culture System to the U.S. market, delivering an important advancement in bloodstream infection diagnostics," said Jianqing Bennett, Senior Vice President, Waters Advanced Diagnostics.The product launch comes as Waters shows strong financial momentum, with revenue growing 26% over the last twelve months to reach $3.77 billion and a market capitalization of $36.5 billion. According to InvestingPro analysis, the stock currently trades above its Fair Value, placing it on the Most Overvalued list, though 12 analysts have recently revised their earnings upwards for the upcoming period.
The system previously received CE mark approval under the European Union’s In Vitro Diagnostic Regulation in April 2026 and was licensed by Japan’s Pharmaceuticals and Medical Devices Agency.
The BD BACTEC FXI Culture System and BD BACTEC Blood Culture Vials are manufactured by Becton, Dickinson and Company or its affiliates. Waters Corporation acquired BD’s Biosciences and Diagnostic Solutions businesses, though BD remains the legal manufacturer until regulatory transfers are completed.
Waters Corporation employs approximately 16,000 people and focuses on analytical technologies for life sciences and diagnostics in regulated testing environments. Investors seeking deeper insights can access the company’s comprehensive Pro Research Report on InvestingPro, which provides expert analysis and actionable intelligence on Waters alongside 1,400+ other US equities.
In other recent news, Waters Corporation reported strong financial results for the first quarter of 2026, with earnings per share of $2.70, surpassing analyst projections of $2.31. The company also posted revenue of $1.27 billion, exceeding the expected $1.20 billion, driven by robust organic growth and contributions from its acquired business from Becton Dickinson. Following these results, Waters raised its full-year guidance, indicating confidence in its ongoing performance. BofA Securities responded by raising its price target for Waters to $370, up from $350, while maintaining a Neutral rating.
The firm noted the company’s impressive quarter, highlighting performance improvements across multiple areas, including legacy business operations. Wolfe Research initiated coverage of Waters with an Outperform rating and set a price target of $425, reflecting a valuation multiple in line with Waters’ historical averages. These developments have contributed to a positive outlook among analysts, with Waters continuing to execute effectively in its core business areas.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.
ProPicks AI evaluates WAT alongside thousands of other companies every month using 100+ financial metrics. Using powerful AI to generate exciting stock ideas, it looks beyond popularity to assess fundamentals, momentum, and valuation. The AI has no bias—it simply identifies which stocks offer the best risk-reward based on current data with notable past winners that include Super Micro Computer (+185%) and AppLovin (+157%). Want to know if WAT is currently featured in any ProPicks AI strategies, or if there are better opportunities in the same space?