RDS Secures CE Mark for its MultiSense Remote Patient Monitoring System

RDS, a medical device start-up has received the CE Mark for its patented, wearable solution for continuous Remote Patient Monitoring, MultiSense. This is a class IIa medical device certification, in compliance with Regulation (EU) 2017/745.
 
The MultiSense device consists of a wearable electronic patch with a secure online platform and associated support services. Healthcare professionals can remotely monitor heart rate, oxygen saturation, respiratory rate, skin temperature, body pressure, and patient’s level of activity in real-time. The current version meets the same standard as a clinical monitoring system and has been tested in six clinical trials.
 
The patch contains five miniaturized biosensors with a patented adhesive layer and a battery pack that lasts at least five days. MultiSense is supplied as a ‘ready-to-use’ kit. To increase sustainability and minimize its carbon footprint, most of the device’s components can be refurbished and reused.
 
“Achieving this pivotal milestone is a testament to the hard work of our technical development teams in recent years – working in close collaboration with the RDS department for quality assurance and regulatory affairs – alongside the many other teams and partners involved in developing this device,” director of quality assurance and regulatory affairs at RDS, Stéphanie Hilbold said. “It demonstrates our company’s ongoing commitment to innovation and excellence in the field of medical technology.”
 
The platform has a secure cloud interface providing remote access to patient monitoring data. It complies with GDPR requirements and its hosting health data provider has a HDS certification. Several different dashboards are provided for visualizing vital signs. It also features various notifications to identify clinical action-required situations. 
 
“The CE mark represents another important step on the path to marketing our solution in Europe,” commented RDS CEO, Ellie Lobel. “We’ve already begun the pre-commercialization phase; the initial results are very positive. Clinicians have shown a keen interest in our device and its potential to transform patient pathways.”
 
MultiSense has been selected for use in a hospital-university research program (RHU) run by Amiens-Picardie University Hospital and at other hospitals and cancer centers in France.
 
RDS is planning for Series A funding to support the development and commercialization of MultiSense.