In March 2026, Nanjing Devin Medical Technology Co., Ltd., based in Nanjing Gaochun Medical Device Industrial Park, received FDA clearance for its independently developed single‑use pulmonary microwave ablation catheter. This marks the world’s first FDA clearance dedicated to pulmonary tumor microwave ablation devices and China’s first FDA market authorization for respiratory interventional minimally invasive medical devices.
Focused on precise minimally invasive tumor ablation, Devin Medical specializes in cutting-edge microwave and radiofrequency ablation technologies. The newly FDA-cleared catheter stands as one of the company’s flagship products for global market expansion. Previously, the firm’s home-grown MRI-compatible non-magnetic microwave ablation needles were adopted by world-leading medical institutions, notably the Mayo Clinic. To date, Devin Medical’s products have entered multiple overseas markets, including India, Egypt and Turkey.
Over six years of operation in Gaochun, the company has evolved from an early startup team into the world’s third-leading enterprise in the minimally invasive ablation sector. It boasts more than 120 independent intellectual property rights and over 20 medical device registration certificates, including seven high-threshold Class-III certifications. The company’s products have been deployed in over 300 Grade-A tertiary hospitals across China. In 2025, Devin Medical exceeded RMB 100 million in annual revenue, achieving robust growth across both domestic and international markets.
Devin Medical’s rapid growth is fueled by tailored industrial support from Gaochun District. Upon the company’s settlement, the industrial park provided end-to-end services, including R&D platform development, production line deployment, and overseas regulatory qualification applications. Addressing the key barrier to international certification that hinders Chinese medical device firms’ global expansion, the park has supported enterprises by providing access to premium professional resources to streamline and accelerate overseas approval procedures. Currently, the industrial park hosts a cluster of innovation-driven medical device enterprises with independent R&D capabilities and global development visions, forming a full-fledged industrial service chain covering in-house research, technological development and global commercialization.
As a core hub of Nanjing’s biomedical landscape, Gaochun Medical Device Industrial Park offers full-cycle professional services for enterprises at all growth stages, including regulatory accreditation support, industry-university-research collaboration, overseas business cooperation and cross-border trade services. Home to more than 3,000 related enterprises, Nanjing’s biomedical industry continued expanding in scale in 2025. As one of the fastest‑growing sub‑sectors, the medical device industry has become a key highlight attracting innovative enterprises to settle in Nanjing. Devin Medical’s landmark FDA achievement fully demonstrates the rising international competitiveness of local innovative enterprises nurtured by Nanjing’s high‑quality biomedical industrial ecosystem.
