Startup TytoCare's Digital Stethoscope Cleared By FDA
TytoCare has announced FDA clearance for its digital stethoscope, the first tool in a portfolio of home-based and clinical solutions aimed at integrating the Internet of Things (IoT) with healthcare. Using modular tools, clinicians will be able to remotely gather vital signs like heart rate, lung function, and temperature without requiring a face-to-face visit.
Israel-based TytoCare has designed two separate systems — TytoHome and TytoPro — that will allow doctors to monitor patients from their homes or seek a specialist opinion during an office visit. The finished comprehensive system will include tools capable of collecting diagnostic information from the heart, lungs, ears, nose and throat, which will be transmitted using a cloud-based platform with video conferencing. The easy-to-use modular tools were designed for use by non-professional, at-home caregivers, patients, or parents.
“By enabling a physical examination that virtually replicates an in-person visit, TytoCare will greatly enhance the ability of school-based clinics, nurses, home health providers, patients and family caregivers to connect and share medical information,” said Karen S. Rheuban, pediatric cardiologist, past president of the American Telemedicine Association, and Chair of Tyto Care’s advisory board, in a press release.
TytoCare CEO and co-founder Dedi Gilad called the solution the “missing link” that would revolutionize telehealth industry and help it reach its full potential. TytoCare has formed several strategic partnerships within the telehealth and healthcare industry to facilitate its rollout. Early investors in the technology include Cambia Health Solutions, Walgreens, Orbimed, and Fosun Pharma.
In 2015, Goldman Sachs released a report projecting telehealth solutions’ potential to reduce healthcare spending by $300 billion per year by moving routine visits and the management of chronic illness out of the hospital and into the home. Major hospital networks, like the Cleveland Clinic, already have integrated IoT technology into their standards of care.
In August, Philips introduced a suite of medical-grade monitoring devices and a digital health app developed to manage chronic disease, and Nokia recently transitioned out of the mobile phone business and into healthcare with the acquisition of telehealth company Withings last May. The FDA is expected to play a critical role in which devices lead the pack in an increasingly competitive field.
CliniCloud introduced a suite of home-diagnostic tools that included an infrared thermometer and stethoscope, which it planned to begin marketing in 2015. The same year, FDA cleared Eko Devices' digital stethoscope, which wirelessly streamed heart sounds to a HIPPA compliant smartphone app.