FDA issues breakthrough device designation for CKD monitoring tool
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Key takeaways:
- The FDA has issued breakthrough device status for a new CKD monitoring tool.
- Manufacturer AWAK Technologies said the device uses artificial intelligence.
AWAK Technologies has received a breakthrough device designation from the FDA for its progression prediction model directed at patients with chronic kidney disease, according to a press release.
The artificial intelligence (AI)-directed model helps clinicians assess the risk of kidney disease progression and determine whether to initiate renal replacement therapy, according to the release.
“This designation is a key milestone which will enable us to accelerate product validation and we look forward to working with the [FDA] agency to help bring this predictive AI model into clinical practice,” Suresha Venkataraya, CEO of AWAK Technologies, said in the release.
AWAK collaborated with Ever Fortune.AI (EFAI), a spin-off company from the China Medical University Hospital (CMUH) based in Taiwan, to develop the model.
The breakthrough device designation from the FDA is granted to novel products that demonstrate the potential to offer substantial benefits over existing medical devices or technologies, according to the company release. It is the second breakthrough device designation the company has received. The first was for its portable peritoneal device system.
“AI is revolutionizing health care with machine learning based data intelligence, providing unparalleled insights,” Chin-Chi Kuo, MD, a medical consultant from the CMUH, said. “The innovative AI models developed using the CMUH iHi (ignite hyper-intelligence) platform exemplify this transformation. These models offer clinicians advanced tools for CKD management, enabling effective risk stratification and optimal resource allocation. This innovation heralds a new era of proactive, intelligent kidney care, showcasing a significant leap in health care technology and digital patient management strategies.”
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