Category
Medical Devices
Wearables, sensors and connected hardware, and the regulation and validation behind them.
4 articles
Newest
AI-Enabled Imaging Devices: What Regulatory Clearance Does and Does Not Tell You
A regulatory listing for an AI imaging tool shows it was reviewed for a defined use, which is not the same as proof it works in every hospital.
How Regulators Treat Software in Medical Devices: Intended Use Comes First
Whether software counts as a regulated medical device depends mainly on what the manufacturer says it is for, not on how the product is built.
Continuous Glucose Monitors Beyond Diabetes: Reading the Evidence Carefully
Continuous glucose monitors are established tools for diabetes care, while their use by people without diabetes rests on far thinner evidence.
Wearable Sensors in Clinical Practice: What Consumer Devices Can and Cannot Tell a Doctor
Consumer wearables record heart rate, rhythm and activity, but clinicians weigh that data differently from a diagnostic-grade measurement.