认知功能筛查及训练软件
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海南又一款数字疗法产品获批上市 我省今年已有3个数字疗法产品获批
Hai Nan Ri Bao· 2025-10-22 01:28
Core Insights - Hainan Province's drug regulatory authority has approved a cognitive function screening and training software for market release, marking the third digital therapy product approved this year [1] - The total number of digital therapy products registered under Class II medical device management in Hainan has reached 11 [1] Industry Overview - Digital therapies are software-driven interventions based on evidence-based medicine aimed at treating, managing, or preventing diseases [1] - The provincial drug regulatory authority has taken the lead in the country by offering specialized consulting services for digital therapies, combining inclusive support with focused cultivation [1] Support and Development - Nearly 100 digital therapy companies have received technical consulting from the provincial drug regulatory authority [1] - A total of 46 companies have been provided with 67 specialized training sessions, assisting 14 companies in registering 15 digital therapy products, effectively shortening the preparation period for product registration [1]