RTX Healthcare Receives FDA 510k Market Clearance For Telehealth Monitor

Main Category: Medical Devices / Diagnostics
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 31 Aug 2007 - 1:00 PDT

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RTX Healthcare announced a 510k market clearance from the US Food and Drug Administration (FDA) to use the RTX3370 Telehealth Monitor in the US. The Telehealth Monitor is a wireless device designed specifically to improve the provision of healthcare to elderly patients outside hospitals suffering from chronic diseases.

The Telehealth Monitor collects vital signs from peripheral devices and subjective patient information from patient questionnaires and transmits the data directly to the disease management company's own clinical information system. The list of peripheral devices certified to be used with the Telehealth Monitor includes scales, blood pressure monitors, blood glucose meters, peak flow meters and SpO2 meters from major medical device manufacturers.

Bjarne Flou, CEO of RTX Healthcare says: "Our Telehealth Monitor is extremely simple and intuitive to use for elderly patients. Furthermore, our business model is quite unique in the market, as we sell the RTX3370 Telehealth Monitor for a one-off fee and not like most others as an integrated product with their own proprietary clinical information back-end solution."

Bjarne Flou continues: "Today, the US spends 16.5 percent of Gross Domestic Product (GDP) on healthcare, making it the number one healthcare spender in the world. An open standard approach to telehealth will ensure seamless interoperability with third-party solutions and will help reduce these costs while at the same time ensuring cheaper, faster and more reliable healthcare solutions for patients worldwide. RTX Healthcare recently joined the Continua Health Alliance, which is fostering independence through establishing a system of interoperable personal telehealth solutions that empower organizations to better manage health and wellness.

About RTX Healthcare A/S

RTX Healthcare focuses on helping people suffering from chronic diseases to live a better and longer life with their disease. RTX Healthcare specializes in the development and manufacture of wireless medical devices for remote monitoring. It is RTX Healthcare's vision is to be known and recognized as a market leader in the healthcare industry at delivering the most appropriate and cost-effective telehealth solutions. RTX Healthcare is a division of RTX Telecom A/S, which is based in Denmark with offices in California, Romania and Hong Kong. RTX Telecom A/S is listed on the Nordic Stock Exchange, Copenhagen (OMX).

http://www.rtx.dk