FDA Cleared Telemedicine Stethoscope Software – Now in Beta at MobilDrTech

Share Article

MobilDrTech, Inc., in partnership with RNK Products is beta testing a new and simplified version of RNK’s popular Auscultation Anywhere telemedicine stethoscope software. The new version provides a significant enhancement as it enables the stethoscope audio stream to be integrated into the video conferencing system’s audio channel, thereby avoiding new networking and firewall traversal issues and is fully FDA approved for telemedicine.

MobilDrTech, Inc., a telemedicine systems integrator and Value Added Reseller for telemedicine equipment manufacturers is beta testing a new and simplified version of RNK Products’ popular Auscultation Anywhere telemedicine stethoscope software. The new version provides a significant enhancement as it enables the stethoscope audio stream to be integrated into the video conferencing system’s audio channel, thereby avoiding new networking and firewall traversal issues. This new software version, for use with the PCP-USB stethoscope, is called PCP-SSP and is fully FDA approved for telemedicine. Early feedback from the beta testing has been extremely positive. Availability - May, 2016.

FDA Technical Considerations for Approval

MobilDrTech provides some of the top hospital systems in the nation with stethoscopes for telemedicine use. In doing so, MobilDrTech strives to provide timely information on the nuances of FDA regulations as they relate to remote auscultation.

There are many misconceptions in the marketplace. In actuality, 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 existing video conferencing equipment can manage the network connectivity between physician and patient sites.

2)    Stethoscope signal processing. The stethoscope signal processing includes digitizing and encoding the signal plus using selectable filters to aid the physician in focusing on sounds of different frequencies such as heart vs lung sounds. Under current regulations, this signal processing functions must be FDA cleared as “accessory” elements to the electronic stethoscope itself.

The PCP-SSP software performs these stethoscope signal processing functions and is approved by the FDA as a Class II Medical Device.

It is important to note that not every electronic or digital stethoscope is FDA approved as a telemedicine stethoscope. Further, if any of the stethoscope signal processing is performed by the PC of the telemedicine system, then those elements are classified by the FDA as accessory elements to the stethoscope and must also 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 is FDA cleared software, telemedicine system providers can feel secure in FDA regulatory compliance when using the PCP-USB stethoscope with the software on their telemedicine carts and systems.

“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 Products, the software developer and stethoscope manufacturer.

ABOUT MOBILDRTECH, INC.
Founded in 2009, and headquartered in Houston, TX, MobilDrTech, Inc. provides Value Added Reseller services to customers wanting to integrate diagnostic equipment into their telemedicine programs. The company specializes in telemedicine stethoscope applications and provides PCP-USB stethoscopes and software for physician, institutional, clinic and home telemedicine programs in the U.S. and internationally.
http://www.usbsteth.com
support(at)mobildrtech.com
+1-281-340-2013

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

Share article on social media or email:

View article via:

Pdf Print

Contact Author

Customer Support
Visit website