The Moda-flx hemodialysis system from Diality. Credit: Diality / Business Wire.

Diality has announced the receipt of 510(k) clearance from the US Food & Drug Administration (FDA) for its Moda-flx haemodialysis system.

This system is designed to provide kidney care professionals with a range of variable flow rate ranges and integrated reverse osmosis water filtration, combined with a user-friendly graphical interface.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Diality CEO Osman Khawar said: “Receiving 510(k) clinical clearance for Moda-flx is an incredible milestone in our mission of developing solutions to improve lives impacted by kidney disease.

“We believe this platform will represent a new paradigm in the treatment of kidney disease and will help reduce the burden of care for all kidney care stakeholders.”

Moda-flx is built to offer clinicians the ability to tailor haemodialysis treatments to individual patient needs within one integrated system. Its compact design and portability facilitate easy integration and transport within various dialysis care environments.

Diality board member Dr Allen R Nissenson said: “Dialysis is an area of medicine long overdue for meaningful innovation.

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.

“The Moda-flx haemodialysis system is a huge leap forward and incorporates the right mix of clinical, technical and ease-of-use characteristics to help dialysis providers thrive in today’s challenging environment. I envision Moda-flx will create value for patients and providers across multiple care settings where dialysis is performed.”

Last November, Diality disclosed its plans to conduct a clinical trial aimed at supporting a home-use indication for the Moda-flx.

The system is intended for use in patients suffering from acute and chronic renal failure, with or without ultrafiltration in an acute, post-acute, and chronic care facility.

The Moda-flx haemodialysis system supports a variety of treatment types including intermittent haemodialysis (IHD), sustained low-efficiency dialysis (SLED/SLEDD), and prolonged intermittent renal replacement therapy (PIRRT).