Regulation
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.
The FDA claims the wearable tech company's BPI offering is "adulterated" and "misbranded," and is being sold without the proper regulatory approvals.
ArteraAI Prostate analyzes digital pathology images of a prostate cancer biopsy slide to help clinicians predict long-term outcomes.
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.
