Awak Technologies Pte Ltd. gained the U.S. FDA’s breakthrough designation for an artificial intelligence (AI)-based kidney disease progression prediction (KDDP) model on Nov. 27, following its $20 million fundraising that marked one of Singapore’s largest med-tech financings in 2023.

Awak Technologies Pte Ltd. and Singapore General Hospital (SGH) plan to launch a pre-pivotal clinical trial for their automated wearable artificial kidney peritoneal dialysis (Awak PD) device. Awak PD is a wearable and portable PD device designed for patients with end-stage kidney disease to have dialysis on the go. The research team is now recruiting subjects for the single-site, prospective, single-arm study.