Nurotron Biotechnology, a developer of neural-electronic medical devices and systems, has announced that it received approval from India’s Central Drugs Standard Control Organization (CDSCO) to sell its Venus Cochlear Implant System in India. Nurotron already holds the CE mark in Europe for the Venus Cochlear Implant (CI) System, and has received approval to sell it in China and Turkey as well.
CDSCO, based in New Delhi, is India’s main regulatory body for pharmaceuticals and medical devices. CDSCO safeguards and enhances public health by assuring the safety, efficacy, and quality of drugs, cosmetics, and medical devices. Nurotron reports that its Venus CI system is safe, reliable, and effective for children and adults suffering from severe and profound hearing loss.
“This approval by India’s primary drug and medical device oversight organization is a major achievement for Nurotron’s cochlear implant system,” said Chu Li, CEO of Nurotron. “The validation of the efficacy of Nurortron’s offerings in the important Indian market confirms the company’s position as a global leader in cochlear implant technology.”
According to its announcement, Nurotron Biotechnology maintains its research and development center in Irvine, Calif, and its manufacturing facilities in China. Founded in 2006, Nurotron is headquartered in Hangzhou, China.
Source: Nurotron Biotechnology Co, Ltd