RNK in Beta for FDA Cleared Telemedicine Stethoscope Software

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RNK Products, Inc. (RNK) is beta testing a simplified version of its FDA approved sSOIP telemedicine stethoscope software that enables the stethoscope stream to go over the video conferencing audio channel. This new software version is called PCP-SSP and works with RNK’s flagship PCP-USB stethoscope.

It is important to note that every electronic or digital stethoscope is not a telemedicine stethoscope.

RNK Products, Inc. (RNK) is beta testing a simplified version of its FDA approved sSOIP telemedicine stethoscope software that enables the stethoscope stream to go over the video conferencing audio channel. This new software version is called PCP-SSP and works with RNK’s flagship PCP-USB stethoscope.

Remote auscultation involves two software elements on the PC:

1)    Network transport of the digitized stethoscope signal. If the digitized stethoscope data stream can be merged with the video conferencing stream, a telemedicine integrator’s video conferencing equipment can handle the network connectivity.

2)    Stethoscope signal processing. The stethoscope signal processing includes digitizing and encoding the signal plus selectable filters to aid the physician in focusing on heart versus lung sounds. This signal processing must be FDA cleared as “accessory” elements to the electronic stethoscope itself.

The PCP-SSP software performs that stethoscope signal processing and is FDA Class II cleared.

It is important to note that every electronic or digital stethoscope is not a telemedicine stethoscope. If any of the stethoscope signal processing is perform by the PC of the telemedicine system, then those elements are classified by the FDA as accessory elements to the stethoscope and must have FDA 510(k) clearance.

Thus, when using an electronic or digital stethoscope that is not a cleared telemedicine stethoscope, a telemedicine system provider is inadvertently operating against FDA regulations. Because PCP-SSP uses FDA cleared software, it provides the regulatory coverage for telemedicine system providers.

“PCP-SSP is an ideal solution for telemedicine networks that want their telemedicine stethoscope signal to go over the same network connection established by the video conferencing system while satisfying FDA regulations” says Rich Abbruscato, CEO of RNK.

ABOUT RNK PRODUCTS, INC.
Founded in 2003, RNK Products, Inc. specializes in electronic and telephonic stethoscopes, under both its own label Telehealth Technologies, and under private labels used by its Value-Added Resellers. RNK offers a range of stethoscopes to fit any institutional or home telemedicine program.
http://www.rnkproducts.com

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Nicole Stefurak
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