Shanghai, China — The National Medical Products Administration (NMPA) has granted Luca Healthcare’s CoughSearch® “Chronic Obstructive Pulmonary Disease (COPD) Assessment Software” a De Novo Innovation designation under China’s special review pathway for Class III innovative medical devices.
This designation marks a major milestone for Luca Healthcare. CoughSearch® is the first AI-driven cough-analysis solution for COPD assessment to receive national-level “Innovation Device” recognition. The designation also reflects the agency’s support for AI and advanced technologies that address real clinical needs and demonstrate clear potential for large-scale adoption.
In 2025, fewer than 60 Class III devices earned admission into China’s innovative approval channel, underscoring the extraordinary rigor and exclusivity of this pathway.
COPD has become a top priority within China’s chronic disease management strategy. Beginning in 2024, COPD was added to the national basic public health program—joining hypertension and diabetes as the third major chronic disease under standardized management. Implementation efforts continued through 2025, reflecting the urgency of addressing a condition that is now the third leading cause of death in China and globally.
A major barrier in COPD management is the limited accessibility of diagnostic tools. Pulmonary function tests (PFTs), the current clinical standard, require specialized equipment, trained personnel, and dedicated space. A single assessment can take more than 20 minutes, making widespread screening and follow-up difficult in primary care and lower-resource settings.
CoughSearch® was developed to lower this barrier. The software enables COPD assessment using a standard smartphone, reducing diagnostic time to under three minutes while maintaining high accuracy. In multi-center, prospective clinical studies using PFTs as the gold standard, CoughSearch® achieved 92% sensitivity (95% CI: 86–96%) and 89% specificity (95% CI: 84–92%).
To ensure real-world robustness, Luca Healthcare built a dataset of more than 30,000 patient samples across 15 regions, spanning all major respiratory conditions. CoughSearch® is powered by a Transformer-based architecture and enhanced with adversarial learning to maintain performance across diverse devices and acoustic environments. This approach delivers consistent accuracy regardless of smartphone model or recording hardware.
Building on this technical foundation, Luca plans to expand into additional respiratory use cases, including AECOPD risk identification, asthma, and upper and lower respiratory tract infections. By enabling low-barrier screening, assessment, and follow-up across a broader range of conditions, Luca aims to improve access to care and advance personalized respiratory medicine.