Next-generation devices that allow continuous non-invasive blood pressure (cNIBP) monitoring are under development as alternatives to cuff-based sphygmomanometers. These include a volume-clamp method using transmural pressure control, a tonometer, and photoplethysmographic sensing based on either the pulse transit time or the second derivative signal. We have prepared a new standard for cuffless sphygmomanometer measurements. Here we report our efforts and discuss the current trends in regulation and approval of novel cNIBP monitoring devices.