NEWS & MEDIA
NEWS / PRESS / EVENTS
Hampton, VA, March 7, 2017 — – ivWatch, LLC, medical device manufacturer of the Model 400 PIV continuous monitoring device, is pleased to welcome Susan Brown, MSN, MSED, as Chief Nursing Officer beginning on March 1, 2017.
Ms. Brown joins ivWatch from her role as a director with patient care services at Children’s Hospital of the King’s Daughters in Norfolk, VA. Her fifteen years of experience in pediatric intensive care include responsibility for operational and clinical care departments including the departments responsible for patient flow, vascular access, resource pool, neonatal/pediatric critical care transport, and others.
She also established protocols, procedures and processes to implement programs improving systems and accountability across the hospital. She was a key member of the hospital-wide process improvement team for CLABSI reduction, completing a comprehensive job instruction training program utilizing the Toyota Production System.
As ivWatch’s Chief Nursing Officer, Ms. Brown will be responsible for developing a new clinical research plan, including the design and execution of clinical research projects. She will also be leading the training programs for hospital staffs implementing the ivWatch Model 400 device in their facilities.
“We could not be more pleased that Susan has joined the team at ivWatch,” says Gary P. Warren, ivWatch President & CEO. “Her nursing experience and leadership skills will enhance our ability to successfully and seamlessly implement our product in hospitals across the United States, as well as continue our dedication to conducting and collecting data through clinical research.”
ivWatch Receives FDA 510 (k) Clearance to Significantly Advance the Safety of IV Therapy for Pediatric Patients
New indication allows for the wide scale implementation to help protect children across the United States
Hampton, VA, January, 5, 2017 – Medical device manufacturer ivWatch, LLC today announced United States availability of the ivWatch Model 400 for pediatric patients under the age of 18. The device is a continuous monitor for a patient’s IV and provides early detection of an infiltration– when medication or fluid leaks outside the vein into the surrounding tissue. Peripheral IVs (PIVs) are one of the most common invasive medical procedures performed with over 150 million IV catheters placed in the Unites States annually, yet current medical reports peg the failure rate of IVs in excess of 20% due to infiltrations. The ivWatch Model 400 was developed to address this unmet need in healthcare.
“We continue to focus on improving patient safety and outcomes,” states Dr. Brian Clare, Chief Medical Officer at ivWatch. “We are excited to be able to offer the ivWatch Model 400 for pediatric patients to enable children’s hospitals and other facilities catering to pediatrics another measure of protection for the early detection of IV infiltration or extravasation events.”
Pediatric patients can be at high risk for infiltrations due to body size and movement. With several hundred pediatric hospitals in the United States alone, the ivWatch Model 400 represents a new option for pediatric medical professionals – a continuously monitored peripheral IV – that can reduce costs, risk, patient harm and medication dosing errors while improving outcomes.
The ivWatch Model 400 received FDA clearance for patients 18 years and older in February 2015 and most recently received FDA 510(k) clearance for patients 17 and under in December 2016. The ivWatch Model 400 is backed by 16 years of research and development and includes a noninvasive sensor that uses near-infrared light to detect changes in the optical properties of tissues. The sensor is coupled to a highly intuitive pole-mounted patient monitor. The device notifies clinicians if conditions suggest an infiltration, allowing them to address the issue early to reduce patient harm.
“We see this new indication as a milestone for the company. By addressing this gap in health care, we are addressing a need in the pediatric space by offering a solution that will reduce harm to children already faced with medical issues,” states John Lawson, President & CEO, W.M. Jordan Company and ivWatch board member. “To offer this type of proven technology to children will further impact and improve patient safety and outcomes for this at risk population.”
“When we received our first FDA clearance, I stated our goal was to be on every IV pole in the country and provide continuous monitoring of every IV placed,” says Gary Warren, President & CEO of ivWatch. “Our ability to offer our product to both adult and pediatric patients places us one step closer to that goal and solving this significant health care problem.”
To learn more about ivWatch and how to begin an evaluation of the ivWatch Model 400, call 1-855-489-2824, Option 1.
 R.E. Helm, J.D. Klausner, J.K.Klempeer, L.M.Flint, and E. Huang, “Accepted but Unacceptable: Peripheral IV Catheter Failure,” Journal of Infusion Nursing, Vol. 38, No. 3, May/June 2015, pp. 189-203
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