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The company’s iCare HOME2 self-tonometer allows patients to collect real-world IOP data at any time.
iCare USA Inc. today announced 510(k) clearance from the US Food and Drug Administration (FDA) for its next generation self-tonometer, the iCare HOME2.
According to the company, the self-tonometer provides ease of use in measuring patients’ real-world IOP outside normal clinic hours to help support glaucoma management. As IOP is the only modifiable risk factor for glaucoma progression, disease management is centered around the reduction of IOP. Therefore, knowing the peak IOP and IOP fluctuation pattern is crucial to help manage patients’ glaucoma.
“Our R&D department has made significant advancements to the iCare HOME2 tonometer,” John Floyd, president and CEO of iCare USA, said in a statement. “Patients can collect real-world IOP data at any time, and with ease.”
The company noted in its news release that most patients can utilize the self-tonometer on their own by following the smart light guide and the interactive display screen.
The self-tonometer’s new design also allows IOP measurements to be taken while the patient is supine, reclined, and sitting. It is easier than ever for doctors to customize glaucoma management based on comprehensive, real-world IOP information.
According to the company, its iCare CLINIC is a cloud-based software that stores IOP data measured by the iCare HOME2 tonometer. The iCare CLINIC reports provide healthcare professionals an in-depth overview of changes in their patients’ IOP status. Patients can actively participate in their eye care management using the iCare HOME2 and PATIENT2 mobile app.
The novel PATIENT2 mobile app allows patients to share IOP measurements more efficiently via Bluetooth using their smartphone for healthcare professional review. Patient motivation for medication compliance can improve, and knowledge of their real-time IOP levels provides daily reassurance.
iCare USA is part of the eye diagnostics company Revenio Group Corp, and its offerings consist of medical devices for the early detection of glaucoma, diabetic retinopathy, and nacular degeneration, and the monitoring of these diseases during the treatment process.