Healthcare Industry News: intended use
News Release - June 19, 2012
InTouch Health Announces New FDA 510(k) Clearance for Its Remote Presence Acute Care Telemedicine DevicesSANTA BARBARA, Calif.--(Healthcare Sales & Marketing Network)--InTouch Health, the world’s premier provider of acute care telemedicine solutions, has received a new Food and Drug Administration (FDA) 510(k) clearance with expanded indications for use for its range of Remote Presence devices which includes RP-7i®, RP-Lite®, RP-Vantage® and RP-Xpress® as well as VisitOR1® which is sold by and is a registered trademark of Karl Storz. The expanded indications for use clear InTouch Health’s Remote Presence devices for active patient monitoring in high acuity environments where immediate clinical action may be required. The clearance specifically allows InTouch Health’s Remote Presence devices to be used for pre-, peri-operative and post-surgical, cardiovascular, neurological, pre-natal, psychological and critical care assessments and examinations.
This clearance is part of InTouch Health’s regulatory commitment to increase its level of compliance with the FDA February 14, 2011 announcement regarding Medical Device Data Systems (MDDS). The MDDS final rule provides clarification on the critical difference between the handling of medical device data intended simply for documentation versus that of active patient monitoring. The FDA indicated in its press release that MDDS classified devices are intended only to transfer, store, convert from one format to another according to preset specifications, or to display medical device data. The final rule further stipulates that as an FDA class I device, an MDDS is not intended to be used in connection with active patient monitoring (i.e. real time, active or online patient monitoring). Any device that transmits, stores, converts, or displays medical device data that is intended to be relied upon in deciding to take immediate clinical action by a health care professional is not an MDDS. Active patient monitoring solutions, such as InTouch Health’s telemedicine devices, are primarily FDA class II medical devices requiring more stringent manufacturer controls. The MDDS final rule is published in the Code of Federal Regulations 21 Part 880, Docket No. FDA-2008-N-0106.
The MDDS final rule also states if a third-party company or hospital (i) develops its own software protocols or interfaces that have an intended use consistent with an MDDS, or (ii) develops, modifies, or creates a system from multiple components of devices and uses it clinically for functions covered by the MDDS classification, then that entity would also be considered a device manufacturer and be subject to FDA regulations.
“With these expanded indications for use, InTouch Health’s platform of telemedicine devices now has clearance for active patient monitoring in high acuity clinical environments with specific language clarifying the allowance of clinical applications of importance to customers in our core TeleStroke and TeleICU markets,” said Dr. Yulun Wang, Chairman and CEO of InTouch Health. “This clearance raises the bar for regulatory compliance in acute care markets and we are proud to have achieved this regulatory objective. We are absolutely committed to stringent regulatory compliance, and we are pleased to provide customers the assurance of knowing that our telemedicine solutions have withstood vigorous testing and are fully compliant with FDA regulations.”
About InTouch Health
InTouch Health integrates end-to-end telemedicine solutions, 24x7 technical support and clinical consulting services in its novel InTouch® Telemedicine System enabling physicians to perform highly reliable, real-time consults with patients. Through a single portal, physicians can access a host of purpose-built, FDA-cleared telemedicine devices to provide care anywhere across the continuum, from EDs, ICUs, procedure rooms and patient wards to clinics, ambulances and homes.
The InTouch Health Remote Presence telemedicine network is powered through its SureConnect® cloud-based infrastructure providing unparalleled connection quality and reliability, interoperability, workflow imaging and documentation, and services and support. Wherever access to medical expertise is limited, InTouch Health's Remote Presence telemedicine solutions can effectively extend the physician's reach to manage patient care, thereby removing critical time and distance barriers.
The Company has more than 500 hospital locations on six continents enrolled in its Remote Presence network for the delivery of telemedicine services such as stroke, critical care, cardiology, trauma, pediatrics, neonatology, behavioral health, language translations, and clinical education and surgical/procedure mentoring.
Source: InTouch Health
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