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Regulation

By Jessica Hagen | 01:02 pm | August 14, 2025
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.
By Anthony Vecchione | 01:30 pm | August 12, 2025
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.
By Anthony Vecchione | 11:34 am | August 12, 2025
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.
By Adam Ang | 09:20 pm | August 11, 2025
Also, Neurophet will tap into Roche's data to further improve its brain scan analysis AI.
By Jessica Hagen | 04:02 pm | August 01, 2025
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.
By Anthony Vecchione | 12:38 pm | August 01, 2025
Organizations are applauding the goals of transparency and patient access to medical data.
By Anthony Vecchione | 03:04 pm | July 28, 2025
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.
By Jessica Hagen | 12:40 pm | July 21, 2025
The FDA claims the wearable tech company's BPI offering is "adulterated" and "misbranded," and is being sold without the proper regulatory approvals.
By Anthony Vecchione | 12:34 pm | July 10, 2025
ArteraAI Prostate analyzes digital pathology images of a prostate cancer biopsy slide to help clinicians predict long-term outcomes.
By Jessica Hagen | 01:30 pm | July 07, 2025
The Swiss company’s over-the-counter wrist wearable, which uses optical sensors to gather blood pressure readings, will be available to U.S. consumers in 2026.