Explore the most recent editions of MPO Magazine, featuring expert commentary, industry trends, and breakthrough technologies.
Access the full digital version of MPO Magazine anytime, anywhere, with interactive content and enhanced features.
Join our community of medical device professionals. Subscribe to MPO Magazine for the latest news and updates delivered straight to your mailbox.
Explore the transformative impact of additive manufacturing on medical devices, including design flexibility and materials.
Learn about outsourcing options in the medical device sector, focusing on quality, compliance, and operational excellence.
Stay updated on the latest electronic components and technologies driving innovation in medical devices.
Discover precision machining and laser processing solutions that enhance the quality and performance of medical devices.
Explore the latest materials and their applications in medical devices, focusing on performance, biocompatibility, and regulatory compliance.
Learn about advanced molding techniques for producing high-quality, complex medical device components.
Stay informed on best practices for packaging and sterilization methods that ensure product safety and compliance.
Explore the latest trends in research and development, as well as design innovations that drive the medical device industry forward.
Discover the role of software and IT solutions in enhancing the design, functionality, and security of medical devices.
Learn about the essential testing methods and standards that ensure the safety and effectiveness of medical devices.
Stay updated on innovations in tubing and extrusion processes for medical applications, focusing on precision and reliability.
Stay ahead with real-time updates on critical news affecting the medical device industry.
Access unique content and insights not available in the print edition of the MPO Magazine.
Explore feature articles that delve into specific topics within the medical device industry, providing in-depth analysis and insights.
Gain perspective from industry experts through regular columns addressing key challenges and innovations in medical devices.
Read the editor’s thoughts on the current state of the medical device industry.
Discover the leading companies in the medical device sector, showcasing their innovations and contributions to the industry.
Explore detailed profiles of medical device contract manufacturing and service provider companies, highlighting their capabilities and offerings.
Learn about the capabilities of medical device contract manufacturing and service provider companies, showcasing their expertise and resources.
Watch informative videos featuring industry leaders discussing trends, technologies, and insights in medical devices.
Short, engaging videos providing quick insights and updates on key topics within the medical device industry.
Tune in to discussions with industry experts sharing their insights on trends, challenges, and innovations in the medical device sector.
Participate in informative webinars led by industry experts, covering various topics relevant to the medical device sector.
Stay informed on the latest press releases and announcements from leading companies in the medical device manufacturing industry.
Access comprehensive eBooks covering a range of topics on medical device manufacturing, design, and innovation.
Highlighting the innovators and entrepreneurs who are shaping the future of medical technology.
Explore sponsored articles and insights from leading companies in the medical device manufacturing sector.
Read in-depth whitepapers that explore key issues, trends, and research findings for the medical device industry.
Discover major industry events, trade shows, and conferences focused on medical devices and technology.
Get real-time updates and insights live from the CompaMed/Medica conference floor.
Join discussions and networking opportunities at the MPO Medtech Forum, focusing on the latest trends and challenges in the industry.
Attend the MPO Summit for insights and strategies from industry leaders shaping the future of medical devices.
Participate in the ODT Forum, focusing on orthopedic device trends and innovations.
Discover advertising opportunities with MPO to reach a targeted audience of medical device professionals.
Review our editorial guidelines for submissions and contributions to MPO.
Read about our commitment to protecting your privacy and personal information.
Familiarize yourself with the terms and conditions governing the use of MPOmag.com.
What are you searching for?
Company obtains CE mark certification alongside CLIA waiver for easy-to-use whole blood analyzer for diabetes care programs.
April 7, 2021
By: Michael Barbella
Managing Editor
EKF Diagnostics has globally launched its STAT-Site WB handheld analyzer, a product that delivers β-ketone and glucose measurements from whole blood in seconds. “STAT-Site WB provides an affordable, easy-to-use technology that can help to reduce the cost of long-term healthcare of the growing diabetic and pre-diabetic population globally,” said Gavin Jones, head of Product Management, EKF Diagnostics. “Having direct access to lab quality β-ketone and glucose near patient results ensures the practitioner has the essential data needed to make informed clinical or lifestyle decisions in seconds.” The product launch follows CE mark certification of STAT-Site WB, as well as a U.S. Food and Drug Administration CLIA-waiver, meaning that the portable, dual-purpose analyzer is ideal for professional use in the management of diabetes patients. The STAT-Site WB is used for the quantitative determination of β-ketones (Beta-Hydroxybutyrate or BHB) and glucose in whole blood taken from capillary or venous samples. The easy-to-use analyzer is reagent free, utilizing two different test strips to deliver results in just 10 seconds for β-ketones and five seconds for glucose. This enables clear and comprehensive management of diabetes patients displaying early symptoms of ketosis, ensuring their rapid treatment and subsequent regular monitoring. βHB is used to aid the diagnosis and monitoring of patients with ketosis (diabetic ketoacidosis or DKA). As β-HB accounts for 78 percent of all ketones present in the body, and is the first to appear during ketosis, it provides the clearest indication of a patient’s condition before and after treatment. The STAT-Site WB is calibrated to the gold standard Liquicolor Beta-Hydroxybutyrate method, meaning that it delivers laboratory accurate results within seconds near to the patient. Further ensuring results accuracy, the handheld analyzer is simple and intuitive to use, even for inexperienced users. The STAT-Site WB auto-starts when a test strip is inserted and will also automatically detect if it is a BHB or glucose test to be undertaken. Just one µL of whole blood is required for direct analysis and the system will also detect and alert if insufficient blood is available. An automatic strip ejection function ensures that cross contamination is avoided. Also making it ideal for remote testing, the analyzer uses two 1.5V AAA alkaline batteries which are easy to obtain and replace, whilst test strips are available individually foil wrapped or in a vial with a shelf life of six months once opened. Results are clearly displayed on a large LCD screen interface with capacity for up to 400 measurements to be stored on the system – these can be downloaded via a mini USB lead.
Enter your account email.
A verification code was sent to your email, Enter the 6-digit code sent to your mail.
Didn't get the code? Check your spam folder or resend code
Set a new password for signing in and accessing your data.
Your Password has been Updated !