Cloud DX (TSX-V:CDX, OTCQB:CDXFF) has announced the publication of an independent peer-reviewed validation study that found its unique Vitaliti product to be fully ISO 81060-2:2018 compliant, clearing the way for regulatory approval starting in 2022.
The virtual care company said the study assessed regulatory compliance and post-surgery use in monitoring patients' vital signs in real-world conditions.
Cloud DX (TSX-V:CDX, OTCQB:CDXFF) noted that the study also found that patients welcomed the comfortable, easy-to-use device. Instead of care teams taking vitals periodically after surgery, Vitaliti was used for continuous monitoring, which could transform post-surgical care by enabling early detection if any deterioration occurs inpatient health, it added.
READ: Cloud DX partners with Medtronic Canada ULC to provide virtual healthcare to patients across Canada
"This third-party validation of our proprietary Vitaliti product can assure patients and doctors that Cloud DX is creating and bringing to market next-generation solutions for improving post-surgical outcomes or medical interventions in general,” CEO and founder Robert Kaul said in a statement.
“Today, patients' vital signs are only continuously monitored if they're in an ICU; in the rest of the hospital, monitoring is only periodic. That approach can miss a rapid change in health status. And when patients are discharged home without continuous vital sign monitoring after an operation, they're at risk for poor outcomes that may have been prevented if they'd had the benefit of early detection through cutting-edge biosensor technology like our Vitaliti product,” he added.
The independent study, titled 'Continuous non-invasive remote automated blood pressure monitoring with novel wearable technology: a preliminary validation study', was conducted by researchers at the Population Health Research Institute and published in the Journal of Medical Internet Research. Findings include that Vitaliti CVSM (continuous vital sign monitoring) demonstrated continuous non-invasive blood pressure (cNIBP) measurement in compliance with international ISO 81060-2:2018 standards.
The authors of the paper include Michael McGillion, Nazari Dvirnik, Stephen Yang, Emilie Belley-Côté, Andre Lamy, Richard Whitlock, Maura Marcucci, Flavia Borges, Emmanuelle Duceppe, Carley Ouellette, Marissa Bird, Sandra L Carroll, David Conen, Jean-Eric Tarride, Prathiba Harsha, Ted Scott, Amber Good, Krysten Gregus, Karla Sanchez, Pamela Benoit, Julian Owen, Valerie Harvey, Elizabeth Peter, Jeremy Petch, Jessica Vincent, Michelle Graham, and PJ Devereaux.
On launch, Cloud DX said Vitaliti will become a key component of its Connected Health ecosystem of remote monitoring technologies.
Through its recent partnership with Medtronic Canada ULC, a subsidiary of Medtronic PLC (NYSE:MDT), a global leader in healthcare technology, the company said wide deployment of Vitaliti is intended to initially improve post-operative care for up to 800,000 surgical patients in Canada annually, and eventually up to several million a year in the United States.
Accelerating virtual healthcare, Cloud DX is focused on making healthcare better for everyone. Its Connected Health remote patient monitoring platform is used by healthcare enterprises and care teams across North America to virtually manage chronic disease, enable aging in place, and deliver hospital-quality post-surgical care in the home.
Contact the author at stephen.gunnion@proactiveinvestors.com