![]() Patients trained to use the iCare HOME device can do so with fair accuracy compared with trainers with accuracy improving within 1 week of usage. 65% of patients agreed the device was easy to use and 89% would recommend the device to other glaucoma patients. No distinct trend in test-retest variability was identified over the 7-day period. At the postloan visit, inter-rater reliability was good for right eye readings and excellent for left eye readings. Good inter-rater reliability was observed between iCare HOME measurements by the glaucoma nurse clinician and patients. Up to 32 patients (80%) were able to obtain IOP readings within 3 mm Hg of the glaucoma nurse clinician’s readings at the preloan visit, and up to 36 patients (90%) at the postloan visit. A 5-point Likert scale questionnaire was used to assess the patient’s experience with the device. Intraclass correlation coefficient compared inter-rater reliability of iCare HOME measurements, and test-retest variability for the patient’s readings over the 7-day period were analyzed. Bland-Altman analysis was used to assess agreement between Goldmann applanation tonometer and iCare HOME readings. Patients were trained to use the iCare HOME and measured their IOP twice daily over a loan period of 7 days. Materials and Methods:Ī total of 40 glaucoma patients had IOPs measured using the Goldmann applanation tonometer and the iCare HOME. The aim was to compare the accuracy of IOP measurements of trained glaucoma patients using the iCare HOME tonometer before and after a week of self-monitoring at home and study the repeatability of patient measurements done at home. Revenio Group Corporation is listed on Nasdaq Helsinki.The iCare HOME tonometer is a useful tool which can be used by patients for fairly accurate and reliable self-measurement of intraocular pressure (IOP). In 2016, Revenio Group's net sales totaled MEUR 23.4, with its operating margin for continuing operations standing at 30.1% from continuous operations. The focus of Revenio's screening technology is on the early detection of glaucoma, osteoporosis, skin cancer, and asthma, and the monitoring of these during the treatment process. ![]() Revenio aims to develop even more efficient and easily adopted methods for the early-stage detection of diseases with significance for public health. Revenio seeks vigorous growth in health technology. The common denominators of Revenio's business operations include screening, follow-up, and the global need to make cost savings through preventive health care. Revenio Group consists of, in addition to the parent company, Icare Finland Oy which focuses on intraocular pressure measurement technology and its fully owned subsidiary Icare USA Inc., research and development company Revenio Research Oy and Oscare Medical Oy, in which Revenio holds a 53.5% interest. Revenio is a Finnish, globally operating health technology corporation whose worldwide success is based on intraocular pressure measurement technology that has a strong patent. The received marketing approval does not have an affect on the 2017 financial guidance. In addition to the United States, the Icare HOME tonometer has been granted sales permits in all European countries and in Australia, Japan, South Korea, Taiwan, Brazil, Canada, and China. Being granted a marketing approval in the United States represents a major opportunity to bring the product to market and, in the future, establish it as a vital part of the glaucoma treatment process", says Timo Hildén, CEO of Revenio Group. For patients diagnosed with glaucoma, continuous IOP monitoring forms a key part of the treatment in order to contribute to preventing progression of the disease and to determine the proper medication. The resulting information on the patient's 24-hour intraocular pressure (IOP) fluctuation would help the doctor to make the proper treatment decisions. "One of our key goals is to create new treatment practices in which a doctor treating a glaucoma patient, or someone suspected of having glaucoma, can lend an Icare HOME tonometer to the patient for around-the-clock home measurement. Icare will immediately start preparations for launching the product in the United States. The company has now been informed that its PMA application has been accepted. In late November 2016, the company filed a supplemented Premarket Approval application to the United States Food and Drug Administration FDA. Revenio Group's subsidiary, Icare Finland Oy has received a marketing approval for the Icare HOME tonometer in the United States. Revenio Group Corporation, Stock Exchange Release March 22, 2017, at 09.30įDA MARKETING APPROVAL GRANTED TO ICARE HOME TONOMETER IN THE UNITED STATES
0 Comments
Leave a Reply. |