From a small volume of whole blood, MeMed BV can precisely measure several proteins found even in low concentrations. Credit: Tatiana from Pixabay.

The US Food and Drug Administration (FDA) has granted a 510(k) clearance to Israeli medtech company MeMed for the use of its BV test on whole blood samples on the point-of-need MeMed Key analyser.

In a span of 15 minutes, healthcare providers will be able to differentiate between bacterial and viral infections through the use of this test.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

From a small volume of whole blood, MeMed BV can precisely measure several proteins found even in low concentrations.

The company stated that a previous version of the test, which was carried out on serum that had received clearance from the FDA in 2021, is being launched successfully in medical centres on the MeMed Key platform besides on high throughput analysers through partnerships with diagnostic companies.

While retaining the performance of its serum counterpart, the new version of the MeMed BV test removes the requirement for clotting and spinning.

This facility allows MeMed to approach decentralised settings in the country, such as urgent care centres, where maintenance and minimal handling are important aspects.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

MeMed CEO Eran Eden said: “The FDA clearance of MeMed BV on whole blood is a significant milestone in our journey to make bacterial versus viral infection testing a standard of care.

“This enhancement to enable testing on whole blood allows for even easier use, faster results and maintains the same level of performance, leading to improved patient care now being available across broader settings in the care continuum.

“By providing a rapid, reliable solution for differentiating between bacterial and viral infections, this test can help reduce the risk of unnecessary antibiotic prescriptions, one of the key drivers of antibiotic resistance.”