Switzerland-based medical technology company Sleepiz has registered its Sleepiz One+ contactless respiration and heart rate measuring device with the FDA. Following the company’s successful market launch in Europe and India, the FDA listing paves the way for Sleepiz to offer its solution for remote patient monitoring and clinical trials in the United States.
Sleepiz One+ is one of the first respiration monitoring devices to track and record patient data in a contactless manner during sleep. Sleepiz’ technology allows for entirely new insights into patients’ health as clinicians no longer have to rely on spot-check measurements but have access to continuous data. This new depth of information allows to detect changes in respiratory rate, which can be an early predictor of diseases like pneumonia and cardiac arrest, or point to an exacerbation in patients with chronic pulmonary disease.
The FDA listing allows Sleepiz partners in the United States to use Sleepiz One+ for remote patient monitoring and integrate the device into clinical study platforms in order to monitor respiration rate in a convenient and clinically-validated way. U.S. physicians can prescribe Sleepiz One+ to their patients to measure their vital parameters over the short and long term, allowing them to gain better insight into patients’ physiological status. For patients, Sleepiz One+ brings a new and convenient way of continuous monitoring at home by simply placing a small device on their bedside table, while they rest.
To drive Sleepiz’ market strategy in the United States, the company has appointed Robb LaChappelle as VP of Sleepiz USA. Mr. LaChappelle is an accomplished business development leader with extensive experience in the fields of medical devices, remote patient monitoring, life sciences and sleep. He has previously worked with innovators like Nonin Medical and Vital Images (Canon Medical) as well as with global players, such as Silicon Graphics/SGI (Hewlett Packard) and Honeywell.
Sleepiz CEO Soumya Dash said: “We are thrilled to welcome Robb to our management team and, together with him, extend the success of our business to the U.S. market. Robb will lead the buildup of our operations in the United States and work closely with our local partners to bring the benefits of our technology to patients, physicians and researchers.”
Sleepiz VP for the United States Robb LaChappelle said: “Sleepiz offers a truly innovative solution, which provides a new level of comfort to patients, while fulfilling the highest standards in terms of data accuracy. I’m looking forward to working with the company founders on establishing and growing our presence in the United States.”
Source: Company Press Release
