Company — Chinese
诺尔康 (Zhejiang Nurotron)
Official site → Hangzhou, China
浙江诺尔康神经电子科技股份有限公司 (Zhejiang Nurotron Neuroelectronic Technology) says on its profile page that it was founded in 2006 and sits in the Future Science and Technology City, Hangzhou, with cochlear implants, visual reconstruction, urinary control and brain-system modulation as product lines (company statement). The registry’s English text calls it “Zhejiang Norkang”.
- Company profile (Chinese): https://nurotron.com/profile.html
- Company news, March 2022, first user of its auditory brainstem implant, developed with Wu Hao’s team at Shanghai Ninth People’s Hospital, 16 electrodes on a 5.5 x 3.5 mm paddle (company statement): https://www.nurotron.com/news/378.html and https://nurotron.com/news/560.html
- Registry record for the NF2 trial: ChiCTR2300070545, phase III, single arm, Shanghai Ninth People’s Hospital, planned April 15, 2023 to December 31, 2026.
- Company news (March 20, 2024) says the review center published its innovative-device special review result on March 15, 2024. The review center’s own notice was not opened.
Device entries
- Auditory brainstem implant is the general entry for this device class (Cochlear’s ABI). No separate Nurotron sheet yet.
Limits
Product claims above are the company’s. The NMPA review notice, the trial results and any approval status are not covered. See the China overview.