Hampton, VA, May 1, 2017 — ivWatch, LLC, is pleased to announce that their Model 400, a peripheral IV monitoring device, is a finalist in the 19th Annual Medical Device Excellence Awards competition sponsored by MD&M East, the largest annual medical technology conference on the East Coast. Winners will be announced during the June conference in New York.
The ivWatch Model 400 is a device that continuously monitors a patient’s peripheral IV for the early detection of infiltrations – when medication or fluid leaks outside the vein into the surrounding tissue. Intravenous therapy is a routine part of treatment for nearly 80% of patients in the U.S., and more than 20% of these IVs may fail because of infiltration. Because every IV failure risks both a serious drug delivery error and tissue damage, earlier detection of those failures is the new and next step for minimizing this potential for patient harm.
The team at ivWatch are recognized leaders in the field of tissue optics, biomedical engineering, computational optical modeling and sensor design. The technological advance represented by this device addresses the challenge of delivering high performance sensitivity and accuracy of reporting, and aligns with the medical industry’s dedication to patient safety and quality of care.
Thanks to close collaboration with nurses and doctors, the Model 400 fits easily into existing workflows. Leading hospitals across the U.S. who have been using the Model 400 are realizing the benefits of this new technology, improving both the effectiveness of drug delivery and the safety of their patients.
The MDEA competition recognizes significant achievements in medical product design and engineering that improve healthcare delivery and accessibility. The awards celebrate the accomplishments of the medical device manufacturers, their suppliers, and the people behind the scenes who are responsible for cutting-edge products that save lives, improve patient care, and transform medtech—one innovation at a time.
From Gary Warren, President & CEO of ivWatch
“It’s an honor to be named as one of the finalists,” says Gary Warren, ivWatch President & CEO. “Having our device recognized by the MDEA judges validates our commitment to helping reduce patient harm and improving patient safety outcomes.”
Suppliers who contributed to the development and production of the Model 400 are Insight Product Development, Phillips-Medisize Corp, Gulf Fiberoptics/Gulf Photonics, and Minnetronix.
Leah Moore, Director, Marketing
855-489-2824 ext. 7031
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.”
Leah Moore, Director, Marketing
855-489-2824 ext. 7031
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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June 30, 2016 – Hampton, VA – ivWatch provided its Model 400 devices that continuously monitor IV sites for the early detection of infiltrations to World Pediatric Project for their recent mission to St. Vincent and the Grenadines.
World Pediatric Project (WPP) sends more than forty-five surgical and diagnostic teams each year to provide critical-care health services in a variety of disciplines to children in the Caribbean and Central America. In a single trip, the teams can provide care and treatment for up to 100 children or more depending on the specialty. Between June 19th and June 21st, a WPP neurosurgery specialist team of doctors and nurses evaluated and treated 54 patients and provided 6 children with critical surgical care.
“Partnering with companies like ivWatch allows us to better achieve our mission to deliver access to quality, critical care to children regardless of geography,” stated Susan Rickman, CEO of World Pediatric Project. “ivWatch stepped in and was very supportive in providing their devices as well as a team member to travel with the devices. We are looking forward to working with ivWatch on future missions.”
Dr. Brian Clare, who serves on the Executive Board of World Pediatric Project and is the Chief Medical Officer at ivWatch, facilitated the conversation between the two organizations. “Being involved with both of these organizations, I knew their missions complimented one another,” stated Dr. Clare. “Just as WPP believes geography doesn’t have to be the reason a child lives or dies, ivWatch believes that every patient should have access to technology and devices that will improve patient safety.”
“It was an experience of a lifetime to be a part of this mission,” Marilyn Bowers, ivWatch Clinical Manager commented. “The compassion of the volunteer medical team, World Pediatric Project, the entire St. Vincent medical staff, and the people of St. Vincent was something I will never forget.”
On this most recent mission to St. Vincent, ivWatch provided the WPP team with their Model 400 devices to help monitor the IVs of the pediatric patients that were designated candidates for surgery and through their recovery.
“This device is definitely a game changer and much needed in developing countries,” stated His Excellency Sir Frederick Nathanial Ballantyne, G.C.M.G, M.D., D.Sc., and current Governor- General of St. Vincent and the Grenadines.
Marilyn Bowers was able to capture the mission through photos. More details can be found on the ivWatch website. For detailed information about World Pediatric Project, visit their website at www.worldpediatricproject.org.
Headquartered in Virginia, ivWatch, LLC is a medical device company focused on improving the safety and effectiveness of intravenous (IV) therapy. Our technology aids clinicians by continuously monitoring a patient’s IV, providing early detection of IV infiltrations – when medication or fluid leaks outside the vein into the surrounding tissue. Because peripheral IVs are one of the most common invasive medical procedures performed in the U.S. each year, and current medical reports indicate the failure rate of IVs in excess of 20% due to infiltrations, ivWatch has delivered an FDA-cleared device in order to address this unmet need. For more information, please visit www.ivWatch.com or call at 1-855-489-2824.
World Pediatric Project is a nonprofit, humanitarian organization founded and based in Richmond, Virginia, that provides surgical and diagnostic care to Central American and Caribbean children while creating and implementing programs to heal the children of tomorrow. This mission is accomplished by mobilizing hospitals and teams of generous pediatric specialists, who volunteer their time and expertise to help thousands of children who need critical care, yet have no access to it in their home countries. With the volunteer help of these dedicated doctors and nurses, World Pediatric Project brings children to partner hospitals in the U.S. and sends pediatric diagnostic and surgical teams to developing countries. Thousands of children have received direct services since 2001. For more information, go to www.worldpediatricproject.org or call WPP at 540-282-8830.
1-855-489-2824 ext. 7031
World Pediatric Project
ivWatch continues its investment in growth by having John Gahan join as Vice President of Manufacturing. He officially joined ivWatch during the first quarter of 2016.
Mr. Gahan has over 30 years of experience in engineering and facility management within highly regulated industries including medical device manufacturing, pharmaceutical, optical manufacturing, and nuclear power. He joins ivWatch from Luxottica Optical Manufacturing where he held multiple engineering and facility leadership positions throughout his tenure. Immediately before joining ivWatch, he served as Engineering Director and was responsible for the installation of new manufacturing operations, testing and development of new manufacturing lines, and served as the lead for Environmental, Health & Safety initiatives.
Prior to his roles at Luxottica, Mr. Gahan held positions in various organizations where he led automation efforts in manufacturing and assembly processes in clean-room environments, as well as the redesign of manufacturing lines in order to meet high demand while creating manufacturing flexibility. His experience includes managing the production and manufacturing processes in large facilities, while adhering to strict regulations such as FDA, ISO, state, federal, environmental, and safety.
In his role of Vice President of Manufacturing at ivWatch, Mr. Gahan is responsible for developing and maintaining the manufacturing processes, and ensuring compliance with medical device quality standards. He will play an active role in our business that makes a difference in improving patient care.
Hampton, VA – May 3, 2016 – ivWatch, a medical device manufacturer focused on improving the safety and effectiveness of intravenous therapy (often referred to as an “IV”) through early detection of infiltrations, today announced that the U.S. Patent and Trademark Office has issued to ivWatch a key patent regarding the use of light to detect if fluids are leaking from an IV.
U.S. Patent No. 9,326,686, titled “System and Method for Mitigating the Effects of Tissue Blood Volume Changes to Aid in Diagnosing Infiltration or Extravasation in Animalia Tissue,” includes claims for detecting such leaks while dealing with the physics associated with patient movement.
The technology behind this patent directly relates to the ability of the ivWatch Model 400 to reduce the number of “false” alarms for our product and not contribute to the ongoing issue and syndrome known as “alarm fatigue”. This serious issue garnished the attention of the Joint Commission back in June 2013, when alarm safety was set as a national patient goal. A recent WSJ article stated that as many as 90% of alarms are false or don’t require any immediate attention. But when clinicians become desensitized to the alarms, they can overlook the 10% of the notifications that are critical, and lead to fatal mistakes. A common cause of false alarms from devices is due to patient movement.
The ivWatch Model 400 includes a noninvasive sensor that uses near-infrared light to detect changes in the optical properties of tissue seen during an infiltration. Changes in the tissue blood volume associated with patient movement affect the signal primarily by changing the amount of hemoglobin, a dominant absorber, in the underlying tissue. The reading from the sensor is analyzed by the highly intuitive pole-mounted patient monitor. The ivWatch technology is able to analyze and detect infiltrations in common IV therapy settings, allowing the patient to move freely while still being continuously monitored. The device will notify clinicians if conditions suggest an infiltration, allowing them to address the issue early to help reduce patient harm.
“This latest patent demonstrates the depth of the science behind the ivWatch technology. You can’t expect a patient to remain still while they are receiving care. Our breakthrough technology has allowed the ivWatch Model 400 to accurately detect infiltrations without impacting patient mobility,” states Gary P. Warren, CEO of ivWatch. “We expect the hard work and dedication of the inventors of this patent to have a meaningful contribution to the improvement of patient safety. Our product provides a new option for medical professionals – a continuously monitored peripheral IV – that can reduce costs, risk, patient harm and medication dosing errors”.
The technology is a core component of the ivWatch Model 400, a FDA cleared device that continuously monitors a patient’s peripheral IV for the early detection of infiltrations, when medication or fluid leaks outside the vein into the surrounding tissue. Peripheral IVs are one of the most common invasive medical procedures performed with over 300 million IV catheters sold in the U.S. annually. Yet, current medical reports peg the failure rate of IVs in excess of 20% due to infiltrations which can cause drug delivery errors and patient harm.
The ivWatch announced U.S. commercial availability of the ivWatch Model 400 in April. To learn more, visit www.ivWatch.com.
About ivWatch, LLC
ivWatch, LLC is a medical device manufacturer focused on improving the safety and effectiveness of intravenous (IV) therapy. The company’s technology aids clinicians by continuously monitoring a patient’s peripheral IV, providing early detection of IV infiltrations.
 (Landro, 2016)