Opto Circuits Ltd. (OCI), India's leading manufacturer of medical diagnostics and interventional products, said it has received Section 510(K) United States Food & Drug Administration (US FDA) approval on two of its new generation range of Pulse Oximeters.
The latest certification enables OCI to market its M30 and M34 Models of Pulse Oximeters in the United States, which is the largest market for these products. A Pulse oximeter is a non-invasive diagnostic device for detecting the pulse rate and percentage of haemoglobin (Hb) that is saturated with arterial oxygen.
Mediaid, the 100 per cent subsidiary of OCI, will begin marketing the product within the US. The global market size for pulse oximeter is estimated to be around US $800mn.
The M30 and M34 models are already being successfully marketed in European and Asian countries.
Model 30 Pulse Oximeter is a handheld device designed for convenience in spot-checking and is ideal for the physician's office, hospitals & clinics, diagnostic centres and home health care. Model 30 has bright LED display visible in most lighting conditions and comes with bar graph displays for Pulse Amplitude and Perfusion Quality indication. The inbuilt rechargeable Lithium Ion Battery runs the oximeter for approx. 18 hours.
Whereas the Model 34 Pulse handheld oximeter is ideal for most continuous monitoring applications, said the company. The salient features of Model 34 are Bright LED display, Bar Graph, Audio / Visual Alarms, Memory, Rechargeable Battery, USB and Infrared Ports and Printer option. Tags patient readings automatically with Patient number, the time and date of the reading, can store 136 hours of information for a single patient, making the device useful for treadmill and other long tests, can be used in walk around test, storing more than 7200 data for up to 20 consecutive patients, can be used for sleep screening where data can be stored every 5 seconds for up to 18 hours. It also enables data to be printed or transmitted to a computer via the Infrared Port or the USB Port. Model 34 Pulse performs approximately 24 hours of operation on a single rechargeable Lithium Ion battery, (sleep mode).
OCI is a leading manufacturer of healthcare equipments in India, which provides digital thermometers, sensors, probes, pulse oximeters, patient monitoring systems, Stents and Catheters. In 2001, OCI acquired 60 per cent stake in Advanced Micronic Devices to market its equipments in India. OEMs contribute (80 per cent) of sales while MediAid (100 per cent US-based subsidiary) contributes the balance. MediAid came into existence with the acquisition of the patient monitoring division of Palco Labs, US, in end-2003 and now markets OCI's products in the US markets directly. OCI acquired EuroCor Gmbh during 2006. EuroCor manufactures Cardiac Stents of various types, including Drug Eluting Coronary stents used in critical cardiac care. In April 2007, OCI ventured into new product segments such as Urology, Gastroenterology, Gynaecology and Orthopaedics by acquiring Devon Innovations Private Limited (Bangalore) and Ormed Medical Technology Limited (Chennai).