AWAK is intending to expand into the US market. Credit: Marko Aliaksandr via Shutterstock.

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.

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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.

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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.