Every year, the Food and Drug Administration (FDA) clears approximately 3,000 medical devices for marketing via the 510(k) pathway. These constitute 99% of all devices approved for human use and includes the premarket review of many devices incorpora...
. The quality of spirometry manoeuvres is crucial for correctly interpreting the values of spirometry parameters. A fundamental guideline for proper quality assessment is the American Thoracic Society and European Respiratory Society (ATS/ERS) Standa...
Journal of the American College of Radiology : JACR
Aug 19, 2023
One of the biggest hurdles to widespread adoption of new procedures and technology such as artificial intelligence (AI) algorithms is payment and coverage policy. Noninvasive assessment of coronary fractional flow reserve is one AI imaging algorithm ...
Animal testing is required in drug development research and is crucial for assessing the efficacy and safety of medications before they are commercialized. However, the newly furnished Food and Drug Administration Modernization Act 2.0 has given new ...
The Journal of thoracic and cardiovascular surgery
Aug 9, 2023
OBJECTIVE: This study aims to characterize the aggregate learning curves of US surgeons for robotic thoracic procedures and to quantify the impact on productivity.
The US Food and Drug Administration (FDA) regulatory process often involves several reviewers who focus on sets of information related to their respective areas of review. Accordingly, manufacturers that provide submission packages to regulatory agen...
Artificial intelligence (AI) promises to revolutionize many fields, but its clinical implementation in cardiovascular imaging is still rare despite increasing research. We sought to facilitate discussion across several fields and across the lifecycle...
Advances in Artificial Intelligence (AI) are poised to transform society, national defense, and the economy by increasing efficiency, precision, and safety. Yet, widespread adoption within society depends on public trust and willingness to use AI-ena...
Journal of biomolecular structure & dynamics
Jul 16, 2023
The latest variant of coronavirus is omicron. The World Health Organization (WHO) designated variation 'B.1.1.529' named omicron as a variant of concern (VOC) on 26 November 2021. By September 2020, it will have infected over 16 million patients and ...
IMPORTANCE: The marketing of health care devices enabled for use with artificial intelligence (AI) or machine learning (ML) is regulated in the US by the US Food and Drug Administration (FDA), which is responsible for approving and regulating medical...