MyHomeDoc Ltd., Remote Personal Examination Solution Provider, has gained FDA 510(k) Class II Clearance For Its Innovative, Comprehensive, and Cost-Effective Device
RAANANA, Israel, April 12, 2021 /PRNewswire/ -- MyHomeDoc today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of the MyHomeDoc system, which uses a multi-sensor device to remotely examine the mouth, throat, lungs, ears, heart, skin, abdomen, body temperature, and oxygen saturation (SpO2).
The device has been cleared for use in testing patients from 2 years old and older, making it suitable for a broad range of primary, chronic, and urgent care modalities for all demographics from pediatrics to seniors.
In a world where telehealth is becoming increasingly center stage, the shortcomings of the pre-existing model point to the need for a more seamless experience for everyone, which will make it possible for physicians to support their clinical decisions with clinically valid physical examination results.
The system utilizes a handheld device that pairs with a smartphone, user-friendly app, and includes a fully adaptable administration panel, best-in-class cybersecurity, and hybrid system architecture that integrates seamlessly with those of proprietary healthcare systems.
In addition, the system introduces multiple clinical workflows to connect patients and physicians with either offline (asynchronous) or online (synchronous) modes.
"We are excited that this FDA clearance—in conjunction with the CE mark that we received earlier this year—will make it possible for more people to benefit from our user-friendly, cost-effective solution that elevates telehealth closer to the in-person clinic visit experience than ever before," says MyHomeDoc CEO Alon Natanson, "MyHomeDoc is an agent of change in the telehealth market enabling flexible business models based on innovative technology."
The systems will be available for commercial deployment in the United States by early May.
About MyHomeDoc
MyHomeDoc is a fast-growing medical start-up, founded in 2016, with offices based in Israel (HQ) and the United States. MyHomeDoc is dedicated to the democratization of primary, chronic and pediatric care within the community, and is pursuing that by introducing new digital enhancements and creating new opportunities for better patient care.
You can reach us for more details: [email protected].
MyHomeDoc is participating this month in the #MEDinISRAEL2021 expo and ACP - Internal Medicine Meeting 2021, come see us at our virtual booth or schedule a time to learn how MyHomeDoc solution adds the dimension of medical-grade data to your video- or telephonic-based virtual care thereby elevating the telehealth experience closer to the in-clinic visit.
Follow us on LinkedIn
SOURCE MyHomeDoc
Share this article