FDA Clears Digital Stethoscope for Remote Medical Exam

Megan Brooks


November 01, 2016

The US Food and Drug Administration (FDA) has granted 510(k) clearance to TytoCare Inc's digital stethoscope, which is intended for use by consumers and will provide the "missing link that will help telehealth realize its full potential," Dedi Gilad, the company's CEO and cofounder, said in a news release.

Until now, clinicians practicing telemedicine had to rely on telephone or video conferencing only to examine and diagnose a patient without the benefit of a physical exam, the company notes in the release. "For the first time we are making it possible to closely replicate, from home, a face-to-face visit to the doctor’s office," Gilad said.

The company has two platforms: TytoHome for consumers and TytoPro for clinicians. TytoHome guides consumers in performing a medical exam remotely to share with their physician. TytoPro enables clinicians to capture digital exam data; integrate with patient health records for continuity of care; and share exam results with patients and specialists, the company says.

TytoCare is also launching digital tools and an integrated telehealth platform to enable remote examination of the heart, lungs, heart rate, temperature, throat, skin, and ears. "Examinations can be done in real time as part of a live video telehealth visit, or in advance of a telehealth session ('exam and forward')," the company explains in the release.

"TytoCare expands the range of conditions that can be reliably diagnosed via telehealth by capturing comprehensive physical exam data at home and delivering it to a remote physician," TytoCare's website explains.

"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," Karen S. Rheuban, MD, pediatric cardiologist, past president of the American Telemedicine Association, and chair of TytoCare’s advisory board, said in the release.

"The use of digital technologies that support high quality remote examinations, when integrated into care delivery models that enhance access both within the context of the medical home and in other settings, promises to transform how patients are treated today. Consumers have demonstrated a strong desire for timely, convenient access to care. TytoCare offers an innovative and important solution to ensure that such care is of high quality, is convenient and meets the standards of the in-person visit," Dr Rheuban added.

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