Huma Therapeutics has been granted Class II clearance from the FDA for its Software-as-a-Medical-Device (SaMD) disease management platform, dramatically expanding the range of services it can deliver.

finally clearing the hurdle two years after the FDA kicked off its 510(k) review of the software as a medical device (SaMD). Company founder Dr Randall Jones has said he was prompted to set up the ...

投资者：听成都朋友说你们迈克生物可以依托DeepSeek的多语言能力，推出全球化AI诊断支持系统提前通过FDA SaMD（软件即医疗设备）认证，获取AI医疗 ...

The Company recently reported that eyonis™ LCS, its AI-powered SaMD for Lung Cancer Screening ... were defined in accordance with discussions held with the FDA. By achieving the primary ...

Paving the way for a disruptive new category in the med-tech space, Nuance Audio Hearing Aid Software is the first FDA cleared, preset Software as Medical Device (SaMD) in the U.S. It delivers a ...

Paving the way for a disruptive new category in the med-tech space, Nuance Audio Hearing Aid Software is the first FDA cleared, preset Software as Medical Device (SaMD) in the U.S. It delivers a ...

The addition of AI and big data integration are key components to help optimize this access, and we are diligently creating a scalable Software as a Medical Device (SaMD) approach, which we ...