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Icare USA, a subsidiary of Icare Finland, has received 501(k) Premarket Notification from the FDA for its Icare Home tonometer for patient monitoring of intraocular pressure fluctuations throughout the day, according to the FDA.
The device received CE Marking in 2014, according to a press release from the company.
“The fact that we can put a tonometer of this caliber in the hands of patients is truly unprecedented,” John Floyd, president and CEO of Icare USA, said in the release.
The Icare Home uses the same patented rebound technology as other Icare tonometers, such as the ic100 and the TA01i. The device requires no specialized skills for patient use, according to the release.
The Icare Home features an automated measuring sequence that can take either a single measurement or a series of six measurements with one touch of a button.
Icare Finland Oy filed the PMA in November 2016, according to the FDA website.
Last reviewed on March 31, 2017