RDS, the medical device start-up, has been granted the CE mark for MultiSense, its patented, wearable solution for continuous Remote Patient Monitoring.
RDS
Stéphanie Hilbold, director of quality assurance and regulatory affairs at RDS, said: “Achieving this pivotal milestone is 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. It demonstrates our company’s ongoing commitment to innovation and excellence in the field of medical technology.”
MultiSense is a Remote Patient Monitoring device comprised of a wearable electronic patch, a secure online platform and associated support services. The current version allows healthcare professionals to remotely monitor six physiological parameters – heart rate, respiratory rate, oxygen saturation, skin temperature, patients’ level of activity and body posture – in real-time - to the same standard as a clinical monitoring system. The device has been tested in six clinical trials.
The patch features five miniaturised biosensors, a patented adhesive layer, and a battery pack with enough capacity to monitor patients’ vital signs for at least five days. It is supplied as a ‘ready-to-use’ kit and most of the components can be refurbished and reused.
The MultiSense platform is a cloud interface that gives healthcare professionals remote access to their patient monitoring data. It features several different dashboards for visualising patients’ vital signs and various notification features to identify situations where clinical action may be required. The platform complies with GDPR and is hosted by a health data hosting provider with HDS certification.
By enabling the remote monitoring of patients’ vital signs, MultiSense helps medical teams improve the quality of life for patients both in hospital and at home. The solution supports an innovative new technological and organisational approach that is transforming care pathways, notably by allowing post-surgery patients to be discharged from hospital sooner and adhering to the principles of Enhanced Recovery After Surgery or ERAS.
Elie Lobel, CEO of RDS, said: “The CE mark represents another important step on the path to marketing our solution in Europe. We’ve already begun the pre-commercialisation phase; the initial results are very positive. Clinicians have shown a keen interest in our device and its potential to transform patient pathways.”
The MultiSense solution has been selected for use in several innovative projects, including a hospital-university research program (RHU) run by Amiens-Picardie University Hospital and an innovation program in oncology (Tiers Lieu d’Expérimentation Onco-Atlantique) headed up by three major cancer centres in Nantes, Angers and Bordeaux, France and the Hospital of Mont-de-Marsan, France.
This year, the company also plans to launch a Series A funding round to support the marketing of MultiSense across Europe, to continue the company’s product development work, launch new clinical trials and register the product with the US authorities ready for its release in the United States, which is planned for 2025.
