FDA approves acute kidney injury test kit

The U.S. Food and Drug Administration has allowed marketing of a new laboratory test that helps determine if certain patients are at risk of developing moderate to severe acute kidney injury within 12 hours of administering the test.

Advertisement

NephroCheck Test, manufactured by San Diego-based Astute Medical, provides a score indicating the patient’s likelihood of developing acute kidney injury within the following 12 hours. There are currently no FDA-approved or cleared tests on the market assessing the risk of developing AKI.

More articles on the FDA:

Recent device recall is largest single-day event ever on FDA record
FDA fast tracks Pfizer’s C. diff vaccine
FDA releases API for medical device data

At the Becker's 11th Annual IT + Revenue Cycle Conference: The Future of AI & Digital Health, taking place September 14–17 in Chicago, healthcare executives and digital leaders from across the country will come together to explore how AI, interoperability, cybersecurity, and revenue cycle innovation are transforming care delivery, strengthening financial performance, and driving the next era of digital health. Apply for complimentary registration now.

Advertisement

Next Up in Supply Chain

Advertisement

Comments are closed.