AWAK Technologies has obtained breakthrough device designation from the US Food and Drug Administration for its AI-enabled kidney disease progression prediction (KDPP) tool.

The KDPP model helps forecast the risk of kidney disease advancement and the start of renal replacement therapy over one, two, and five years.

AWAK and Ever Fortune.AI, a spin-off company from China Medical University Hospital in Taiwan, teamed up to create this new AI solution.

In September 2021, the two organisations signed a strategic partnership to transform the diagnosis, treatment, and management of kidney disease. They planned to achieve this by developing solutions that leverage medical ‘big data’ and AI.

AWAK CEO Suresha Venkataraya said: “This designation is a key milestone, which will enable us to accelerate product validation and we look forward to working with the agency to help bring this predictive AI model into clinical practice.”

Leveraging the hospital’s deidentified chronic kidney disease patient database, AWAK and Singapore General Hospital will focus on developing new AI models and testing the existing KDPP model.

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.

AWAK is currently in advanced talks with US partners to introduce its products into the American market.

To lead this expansion, AWAK is moving its chief business officer Andar Gorin to California, to establish a local presence and expedite partnerships in the area.

The US team will work on building clinical, regulatory, and other necessary capabilities.

In September 2023, AWAK received more than $20m in Series B funding for the trial of its wearable dialysis device in the US.

The company stated its plans to use the proceeds for various crucial initiatives to conclude its ongoing human prepivotal clinical study with Singapore General Hospital.