IOP self-monitoring device clears FDA

The FDA has approved Icare HOME, a rebound tonometer designed for patients to use at home, offering the ability to track IOP fluctuations throughout the day.

The handheld device uses the same patented rebound technology as other Icare devices available to clinicians, such as the ic100 and the TA01i.

“The fact that we can put a tonometer of this caliber in the hands of patients is truly unprecedented,” says John Floyd, president and CEO of Icare USA. “The Icare HOME makes doctors aware of dangerous spikes that they may never have known about otherwise. The impact and level of care that this provides cannot be overstated.”

Patients don’t require special training to operate the device. It doesn’t require drops or use an air puff. It can automatically distinguish between right and left eyes, and red/green light signals alert the user when the tonometer is correctly positioned. The device can take a single measurement or a series of 6 measurements with a single button.

While a study published in Ophthalmology showed that Icare HOME can obtain IOP measurements comparable to Goldmann applanation tonometry, it also revealed that 1 in 6 patients were unable to obtain accurate measurements. The device was also found safe and comfortable for patients.

Icare HOME received CE Marking in 2014, and is used across Europe.