Opto Circuits Ltd (OCI), leading manufacturer of medical diagnostics and interventional products, announced, that Mediaid Inc.; a wholly-owned subsidiary, has received approval from the United States Food and Drug Administration (FDA) for key vital sign monitoring products; Model 900, a bedside monitor, and Model 960, a vital sign monitor.
The Model 900 and Model 960 Vital Sign Monitors are the first Opto bed-side monitor to receive the crucial approval for marketing in the United States. Both monitors incorporates Mediaid's core technologies, all future products will use the algorithm from the above 2 units. Technology from these units will also be licensed to other OEM manufacturer world wide.
These units will also improve sales of disposable sensors. The Model 900 and 960 devices monitor Blood-oxygen, Blood-pressure and Temperature for a complete and quick assessment of vital signs.
Highlighting the significance of approval, Vinod Ramnani, chairman and managing director, OCI, said, "With the US FDA approval, we have achieved a further milestone in creating key vital sign monitoring products. Receiving approval for these high-end products opens up the US hospital market. These monitors have been designed and developed by Opto's Research and Development centre at Bangalore".
"Majority of the products with Mediaid Brand either have CE or FDA or both. Opto will continue adding more products in the Patient monitoring segment using its own core technologies. Opto is one of very few companies in India that has FDA approval for core technologies," he further added.
Desktop Monitors are used for a continuous Non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), Pulse rate, non-Invasive blood pressure and temperature. The intended environment of use is hospital environment. Hospital use typically covers areas such as general care floors. Operating rooms, special procedure areas, intensive and critical care areas within the hospital plus hospital-type facilities such as surgical centres, sub-acute centres special nursing facilities and sleep labs.