Regulation
ArteraAI Prostate uses digital pathology images from a patient’s biopsy to predict potential long-term outcomes of their prostate cancer.
ArteraAI Prostate forecasts potential long-term outcomes of a patient's prostate cancer biopsy slide based on digital pathology images.
The company's CEO defended its feature as a wellness tool under the 21st Century Cures Act, combating the FDA’s claim that it qualifies as a regulated medical device.
The feature will be available via new iOS and watchOS updates, one year after the U.S. International Trade Commission banned Apple from selling its Series 9, Series 10 and Ultra 2 watches.
Nyxoah is in the midst of a lawsuit brought on by Inspire Medical Systems alleging infringement of several patents related to its recently-cleared offering, Genio.
The Conference Board's principal economic policy analyst PJ Tabit says that while the plan is helpful, it is not a comprehensive framework for how to regulate AI.
Also, Neurophet will tap into Roche's data to further improve its brain scan analysis AI.
The EU says makers and distributors of health-related app stores or applications will now be considered medical device makers and must adhere to associated regulations.
Organizations are applauding the goals of transparency and patient access to medical data.
The platform assesses cognitive and motor function via at-home assessments that generate digital biomarkers and a predictive score, supporting the early detection of Parkinson's.