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FDA Grants 510(k) Clearance To Urodynamix Technologies’ UroNIRS 2000 Bladder Monitor System

Urodynamix Technologies Ltd. announced that it has obtained 510(k) clearance from the US FDA to market the UroNIRS 2000 Bladder Monitor System – a second generation non-invasive medical device that uses near infrared spectroscopy (NIRS) to aid in the diagnosis of lower urinary tract symptoms (LUTS) in a urology office setting. “We are pleased to achieve another major milestone in the execution of our business strategy. The Company has orders in hand and will begin shipments of the uroNIRS 2000 in the first quarter of 2009. This new 510(k), received in 94 days, is another example of continued excellence in execution of our product development strategy. The uroNIRS 2000 is a key part of our expansion from the acute care market into the larger office based urology market. This device will be more accessible, user friendly and cost effective than our previous version and will allow expansion into the larger urologists office market where our non-invasive fast diagnostic procedure will have the most value." said Barry Allen, President and CEO of Urodynamix "In addition to our existing relationships with MMS and Laborie, we will expand our distribution in the short term to include broader office based distribution channels.” UroNIRS 2000 is based on a wireless tablet PC with Urodynamix’s proprietary sensor configuration and is compact, portable and specifically designed for ease of use in the physician’s office setting. The non-invasive procedure is used to confirm the presence of bladder outlet obstruction in men by identifying patients that have healthy bladder function yet suffer from weak urinary stream, hesitancy, urinary retention and related symptoms. UroNIRS 2000 is safer, faster, less expensive and more comfortable than conventional catheter-based diagnostics for the same condition. Clinical studies have shown that the UroNIRS 2000 device has an 86% success rate for accurately identifying obstructed male patients, most of whom are good surgical candidates. The company has applied for and expects to receive CE mark for European approval of the device in the first quarter of 2009, for European launch in the second quarter.