1 LongHua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China 2 Gansu Provincial People’s Hospital, Jangsu University, Gansu, China Objective: To investigate the therapeutic ...

FDA Commissioner Marty Makary announced policy shifts that ease the path to market for certain digital health technologies, including AI- and generative AI-enabled clinical decision support software ...

Abstract: The software supply chain has become a critical attack vector for adversaries aiming to infiltrate software development workflows by injecting malicious code into third-party packages and ...

NEW YORK--(BUSINESS WIRE)--AccurKardia, an innovator in ECG-based diagnostics technology, has announced the initiation of a multicenter clinical pilot of AK+ Guard TM, an FDA Breakthrough Device ...

FDA updated two key digital health guidance documents to align with the Administration’s emphasis on deregulation and innovation in health care technology, including the use of generative AI. The ...

A cochlear implant (CI) is a medical device that restores hearing to individuals with severe to profound sensorineural hearing loss. The CI electrode array is surgically implanted in the scala tympani ...