ivWatch announces new Vice President of Manufacturing, John Gahan

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.

ivWatch Announces Issuance of U.S. Patent for Solving Motion Issues Related to Continuous Peripheral IV Therapy Monitoring

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[1].  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.

[1] (Landro, 2016)

ivWatch Announces Availability of a New Medical Device to Continuously Monitor IVs

The ivWatch Model 400 will improve patient safety through early detection of IV infiltrations and extravasations and provide a new option for IV therapy.

Hampton, Va. — April 5, 2016 — Medical device manufacturer ivWatch, LLC today announced United States availability of the ivWatch Model 400, a device that continuously monitors a patient’s IV for the early detection of infiltrations – 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 U.S. 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.

“A procedure that is this common in healthcare should not have such a high failure rate,” said Gary Warren, CEO at ivWatch. “IV failure due to infiltrations is commonly accepted. We need to make it unacceptable.”

Complications of PIV infiltration range from pain and redness to severe tissue damage and amputation. To avoid IV failure, clinicians have defaulted to using other, more intrusive vascular access devices. Peripherally inserted central catheters (PICC), for example, unfortunately carry other serious risks, such as central-line-associated bloodstream infections, commonly referred to as CLABSIs.

The ivWatch Model 400 represents a new option for medical professionals – a continuously monitored IV – that can allow peripheral IVs to be an appropriate alternative for infusion therapy that can reduce costs, risk, patient harm and medication dosing errors.  The ivWatch Model is the result of more than 16 years of intensive development and clinical testing. The FDA cleared the device for use in 2015.

“It’s like a seatbelt,” said Warren. “Since it’s difficult to predict when an accident will occur, people wear their seatbelt for the duration of their travel. Similarly, since it’s difficult to predict when an infiltration will occur, and we know it occurs too frequently, the ivWatch Model 400 represents a seat belt for patients with an IV. Our continuous monitoring device not only improves patient safety, but can help minimize the risk and avoidable costs for health care provider organizations.”

The device includes a non-invasive sensor that uses visible and near-infrared light to detect changes in the optical properties of the tissue. The sensor is coupled with a highly intuitive, pole-mounted patient monitor.  The device will notify clinicians if conditions suggest an infiltration, allowing them to address the issue early to help reduce patient harm.

 About ivWatch, LLC

Headquartered in Hampton, Virginia, ivWatch is a medical device manufacturer focused on improving patient safety and effectiveness of IV therapy.  The company’s technology aids clinicians by continuously monitoring a patient’s IV, providing early detection of IV infiltrations and extravasations.

Please contact Melissa Fire, Vice President of Sales, for information on pricing and evaluation opportunities at sales@ivwatch.com or 757-817-9040.

Leah Moore

Director of Marketing, ivWatch, LLC

1.855.489.2824 ext. 7031

Leah.Moore@ivwatch.com

ivWatch welcomes Mike Gahan, Vice President of Operations

Williamsburg VA, March 2, 2016 – ivWatch is pleased to welcome Mike Gahan as Vice President of Operations. He officially joined the ivWatch team on February 15, 2016.

Previous to ivWatch, Mr. Gahan served as Vice President of Operations at Transnetyx. Mr. Gahan was responsible for the day-to-day operations of the company, including the management of Medical Laboratory Technicians and Medical Technologists and their supervisors as well as engineering, maintenance and logistics to maintain daily operations, planning for expansions, inventory management, and overall assurance that capacity meets client demand.  Transnetyx is a molecular diagnostics company providing high throughput, automated genetic testing services to the research industry.  Mr. Gahan also served as Vice President of Operations of Harmonyx, Inc., a sister company of Transnetyx, which is a CLIA/CAP certified and HIPAA compliant automated pharmacogenetic testing laboratory.

Prior to joining Transnetyx in 2004 (initially as Operations Manager until he became Vice President of Operations in 2008) and Harmonyx in 2008, Mr. Gahan was with Ciba Specialty Chemicals for 17 years in a variety of roles, including development engineer, automation engineer, production engineer, programs manager, project leader and operations manager.  While with Ciba, he was responsible for two production units with a $60 million asset value, producing $50 million in annual sales of specialty monomers.

In his role of Vice President of Operations at ivWatch, Mr. Gahan will be responsible for leading the company’s day to day operation enabling increased organizational alignment to achieve greater efficiencies as ivWatch continues to grow.

About ivWatch – 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.

Contact Information:  Leah Moore    leah.moore@ivwatch.com    855-489-2824 ext. 7031

ivWatch, LLC Receives 2016 Virginia Governor’s Outstanding STEM Award for Science Innovation

ivWatch, LLC will be honored for their innovative device that provides early detection of IV infiltrations and can help reduce patient harm.

Williamsburg, VA – ivWatch, a medical devices company, is one of five recipients to receive a Virginia Outstanding STEM Award granted by Governor Terry McAuliffe’s office. ivWatch will be receiving the STEM Award for Science Innovation on February 25th at an event to be held at the Science Museum of Virginia. The STEM award honors professionals and business that have made significant contributions to science.

ivWatch is being honored for their ivWatch Model 400, 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. 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. To address this unmet need, the dedicated ivWatch team delivered an FDA-cleared device in 2015. The ivWatch Model 400 includes a noninvasive sensor that uses near-infrared light to detect changes in the optical properties of the tissue. The sensor is coupled to a highly intuitive pole-mounted patient monitor. The device will notify clinicians if conditions suggest an infiltration, allowing them to address the issue early to reduce patient harm. The ivWatch Model 400 represents a new option for medical professionals – a continuously monitored peripheral IV – that can reduce costs, risk, patient harm and medication dosing errors.

The ivWatch Model 400 is backed by 16 years of research and development in areas that include photon/tissue interaction modeling, signal processing algorithm development and optimization, user interface research and design and extensive clinical testing. Gary P. Warren, CEO of ivWatch and former NASA Engineer says “The depth of science behind the ivWatch product line is truly amazing. For a small company, our research and associated intellectual property in this area rivals anything I have seen coming from large companies, universities or government labs. We have an incredible team of talented people here and are honored by this award.”

ivWatch was also the winner of the Governor’s Virginia Velocity Competition in September 2015 for the best bio-science business plan.

 

Medical and technology leaders advise ivWatch, LLC on devices to improve patient safety

Williamsburg, Va.—December 23, 2015—Nationally recognized experts in fields ranging from anesthesiology to infusion nursing are helping ivWatch, LLC develop next-generation devices to improve patient safety. The five leaders are members of a Clinical Advisory Council for ivWatch, which soon will launch its continuous monitoring device to minimize injuries from intravenous (IV) therapy.

IV infusion is the most common invasive hospital procedure performed worldwide, but IVs can fail as often as half the time. When they fail, fluid or medication enters the surrounding tissue rather than the patient’s vein — a condition called peripheral IV infiltration — resulting in complications that range from pain and redness to severe tissue damage. Because of this failure, clinicians have defaulted to using other more intrusive vascular access devices that have other serious risks, such as central-line-associated blood stream infections, commonly referred to as CLABSIs.

The ivWatch Model 400 enables an IV to be continuously monitored, aiding clinicians in the early detection of infiltrations by automatically notifying them. The FDA has cleared the device for use with adults and it will be available for sale early in 2016.

“Our Clinical Advisory Council includes highly experienced vascular experts and other clinicians who’ve dedicated themselves to the mission of protecting patients,” said Gary Warren, CEO at ivWatch. “Their input has been invaluable in developing our inaugural safety device, and they are active contributors to other technological advances in our pipeline.”

The ivWatch Model 400 includes a patient monitor, a non-invasive sensor using visible and near-infrared light, and a disposable sensor receptacle applied next to the IV site. A color LCD screen displays the status of the IV and an audible notification sounds if an infiltration occurs.

The Clinical Advisory Council members include:

Gregory J. Schears, MD, Advisory Council Chairman and Chief Clinical Officer

Dr. Schears serves in a variety of roles at Mayo Clinic in Minnesota. He is medical director for ECMO Services, a physician liaison for the Nurse PICC Team, co-medical director of the Cardiovascular Pediatric Surgical ICU and a consultant for the Department of Anesthesiology. Dr. Schears also is a practicing pediatric intensivist and anesthesiologist, and serves as an associate professor of anesthesiology at Mayo Clinic College of Medicine.

Lisa Gorski, RN, MS, CS, CRNI

Ms. Gorski — a clinical nurse specialist with Wheaton Franciscan Home Health and Hospice in Wisconsin — is nationally recognized for her expertise in infusion nursing and chronic illness. Ms. Gorski is widely published on the topic of home-infusion therapy, including the 2010 textbook, “Infusion Nursing in Clinical Practice: An Evidence-Based Approach.” She also is past president of the Infusion Nurses Society.

Melissa C. Whitehead, BSN, RN, CPN, CRNI

Ms. Whitehead is clinical manager for seven teams at Children’s Medical Center in Dallas, Texas. Those teams include Vascular Access, the Wound-Ostomy-Continence Program and Patient Care Technicians. Ms. Whitehead is a member of the Association for Vascular Access and the Infusion Nurses Society. She has presented on numerous topics, including common complications of PIV therapy and current methods used to help minimize complications.

Liz Sharpe, RN, DNP

Ms. Sharpe is a neonatal nurse practitioner and educator, with a special interest in vascular access in neonatal and pediatric patients. An assistant professor at the University of Alabama’s School of Nursing, Ms. Sharpe also serves on the board of the National Association of Neonatal Nurses and the Vascular Access Certification Corporation. She is active in the Association for Vascular Access and the Infusion Nurses Society, and is an author, reviewer and consultant on the topic of vascular access.

Steven Bierman, MD, Chief Medical Officer at Access Scientific

Dr. Bierman founded Venetec International in 1996, which set a worldwide safety standard for management of intravascular and urinary catheters. The company sold to CR BARD in 2006. His new company, Access Scientific, LLC, is dedicated to establishing a new standard of over-wire vascular access.

# # # 

About ivWatch, LLC

Headquartered in Virginia, ivWatch develops, markets and sells biomedical sensor technology focused on improving patient safety in infusion therapy and vascular access. The company’s inaugural device, the ivWatch Model 400, is a first-of-its-kind continuous monitoring device, cleared by the FDA, which quickly alerts providers of possible peripheral IV infiltration.

The concept for the ivWatch Model 400 originated in 1999, and is the result of more than 14 years of intensive development and clinical testing. These efforts have led not only to the development of the ivWatch Model 400, but the technology has also resulted in 60+ utility patents that will be used to continue to improve patient safety in other ways.

More information is available at ivwatch.com.

 

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