Public Policy
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.
Kristen Valdes, CEO of b.well Connected Health, spoke with MobiHealthNews about how CMS' newly launched Interoperability Framework fits into the company's vision for the future.
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 UroNav system uses MRI and ultrasound images for more precise, minimally invasive care.
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.
The wristband is designed to alleviate essential tremors by modulating the nervous system and restoring motor control.