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In anticipation of FDA’s virtual public workshop on transparency of artificial intelligence/machine learning (AI/ML)-enabled medical devices scheduled for October 14, 2021, we will be...
3 Tips For Designing At-Home Monitoring Devices That Deliver Actionable Information By Anna (Ronning) Cohen and Hilde Viroux, PA Consulting We’re all seeing it in real time: Healthcare is increasingly shifting from clinical settings to our homes. The COVID-19 pandemic has accelerated the development of at-home monitoring products and many are collecting data in the background without requiring specific user action. This acceleration is not likely to slow down post-pandemic. In this article, we define “passive at-home monitoring tools” as non-invasive products that continuously monitor e...
[author: Daniel Meckley] Today’s wearable devices — the ones that monitor the number of steps we take, our heart rate, and our sleep habits (to mention only a few) — walk the line between personal accessories and true medical devices. To clarify the differences the FDA has issued several guidance documents including “General Wellness: Policy for Low Risk Devices” and “Policy for Device Software Functions and Mobile Medical Applications.” Just recently, the FDA granted permission to market Nightware, a new device intended to treat sleep disturbance related to nightmares in adults...