About Us

Improving Patient Outcomes One IV at a Time

ivWatch was established with the mission to eliminate the harm done by IV infiltrations and extravasations to help improve patient outcomes. At ivWatch, we believe that by working together, we can enhance patient safety, advance patient care, and set a new standard in healthcare.

Our Leadership Team

Chief Operating Officer
Jaclyn Lautz, PhD

VP, Regulatory Affairs and Quality Assurance
Holly Novak

Vice President of International Sales, EMEA
Helen Stephens

President & CEO

Gary Warren

Gary Warren currently serves as president and CEO of ivWatch and has championed the development of non-invasive biosensors that fulfill a huge patient safety need in health care. Starting ivWatch in 2010, Gary assembled a team of leading scientists, clinicians, hospitals and investors to solve a common drug delivery problem of IV infiltration and extravasation. Gary has guided ivWatch through multiple ISO audits and FDA clearances for this breakthrough technology with ivWatch products now being sold on the international market.

Gary has a multidisciplinary background with a 14-year career as a research scientist at NASA in aerospace and computational fluid dynamics. He departed NASA to start a successful Internet infrastructure company in the mid-1990s and served as CEO until it’s sale to Symantec in 1999. At Symantec, Gary served as a senior vice president and oversaw advanced technologies, mergers and acquisitions and gateway software products. He also served as a member of the senior executive staff. After Symantec, Gary served as CEO for a venture-backed mobile platform company as smartphones were beginning to emerge as a market. After the sale of this company to Oracle, Gary worked for various venture capital companies doing financial analysis and due diligence which brought him to the work being done on IV infiltrations under a National Institutes of Health (NIH) grant. Since bringing over the core engineering talent and founding the company, Gary has grown ivWatch to an award-winning brand in health care that is setting a new standard in IV therapy care.

Chief Financial Officer

Kathy Cox

Kathy Cox is the Chief Financial Officer overseeing the accounting and finance functions at ivWatch. She joined the company in June 2021 with a history of helping businesses drive growth and implementing operational improvements while building strong and efficient teams. Kathy brings an array of professional financial and operational experiences with companies privately owned and those held by global publicly-traded parent companies. Her industry experience includes medical device manufacturing, healthcare, software, and public accounting. Kathy is a CPA with over 23 years of experience, with the past 15 years spent in the medical device manufacturing and healthcare markets.

Prior to joining ivWatch, Kathy held a series of executive positions for 12 years within Solesis, an operating division of Michelin and Fenner PLC, including Director/General Manager and Finance Director at Charter Medical and Finance Director at Xeridiem Medical Devices.

Chief Operating Officer

Jaclyn Lautz, PhD

Jaclyn Lautz is responsible for oversight of research and development, manufacturing, human resources and operations. She leads all product development and innovation efforts for ivWatch, including directing the engineering teams on the design and development of new products and working across departments to bring new products to the market.

Jaclyn joined ivWatch in 2018 from Pricewaterhouse Coopers (PwC) where she was an advisory manager in the pharmaceutical and life sciences operations practice. Prior to that, Jaclyn was ivWatch’s Director of Regulatory Affairs & Quality Assurance and also held several biomedical engineer positions. Jaclyn has a Ph.D. in mechanical engineering & materials science from Duke University where she worked with industry partners on new medical devices and treatment strategies for urological diseases. Her work is published in several physics and medical journals. She was awarded the NSF Graduate Research Fellowship and the NSF Engineering Innovation Fellowship for her graduate studies at Duke University.

Chief Marketing Officer

Erin Wendell

Erin Wendell, the Chief Marketing Officer at ivWatch, leads the strategic vision and direction for ivWatch’s global branding and messaging, digital presence, internal and external communications and experiential marketing. Erin oversees all aspects of the company’s global brand marketing strategy. Erin has successfully built global marketing communications initiatives, directives and experiences for nearly 15 years.

Prior to beginning work at ivWatch, she served as the Senior Director of Global Communications at Under Armour. At Under Armour, she played a critical role in growing the communications function from its inception, driving brand awareness, executing entries into global markets, launching major campaigns and products and establishing best in class media and employee communications practices.

VP, Regulatory Affairs and Quality Assurance

Holly Novak

Holly Novak is responsible for ensuring compliance to all applicable standards and leads the ivWatch Quality Management System (QMS). Prior to joining ivWatch, Holly has spent the past 15 years in various roles within R&D, Production and Quality Assurance for products that required both USDA and FDA clearance.

In her most recent positions, Holly implemented and maintained an ISO compliant Quality Management System for a medical device company, and more recently for a global supplier of raw materials that served the pharmaceutical, device, government agencies and university markets. She also played an instrumental role in attaining CE marking for the entire product line for Maine Standards Company, a market leader for linearity and calibration verification products.

Vice President of International Sales, EMEA

Helen Stephens

Helen Stephens, the Vice President of International Sales, EMEA at ivWatch, leads the company’s international expansion plans from the United Kingdom. She is responsible for directing the international distributor program and paving the way into new markets. She provides a wealth of knowledge to drive growth in the EMEA region and select other global high-demand markets.

She has a tenured 30-year diverse career, as a nurse at the bedside and with experience in medical device sales at companies including Becton Dickinson, Vygon, Smiths Medical, and most recently ICU Medical, where she served as the Infusion Product Sales Manager, EMEA. In her career, Helen has held various leadership roles in Sales, Business Development, and Clinical. Helen is a registered general nurse and holds a degree from Frances Harrison College of Healthcare, University of Surrey.

“I want to type in ‘IV Infiltration’ into a search engine in 10 years and the horrible images are all gone.”

PRESIDENT & CEO, GARY WARREN

Our Story

Founded in 2010, ivWatch continues our mission with a singular focus to prevent patient harm by monitoring and detecting IV infiltrations. Our company and our technology have continuously evolved, developing and bringing to market the world’s first sensors and monitor that are uniquely created to detect peripheral IV infiltrations at their earliest stages. Our innovative design offers clinicians the ability to intervene well before harm can be seen by the human eye to enhance patient safety and reduce liability.

Today, ivWatch teams, including research and development, manufacturing, clinical, sales, and marketing, are supported by key partnerships and a network of international distributors. These relationships allow us to bring our one-of-a-kind solutions to the global healthcare market.

Founded in 2010, ivWatch continues our mission with a singular focus to prevent patient harm by monitoring and detecting IV infiltrations. Our company and our technology have continuously evolved, developing and bringing to market the world’s first sensors and monitor that are uniquely

created to detect peripheral IV

NIH Grant Phase 1 | Animal Testing

Feasibility of optical measurement to detect infiltrations.

2001-2009

NIH Grant Phase 2 | Human Volunteer Testing

Prototype results indicate high sensor sensitivity.

NIH Grant Continuation | Hospital Patient Testing

Technology tested in a clinical setting.

2010

2011

ivWatch, LLC Established

From small research company to ivWatch, LLC.

Pediatric Pilot Study

127 pediatric patient pilot study using a prototype at Cincinnati Children’s Hospital.

2012

2013-2014

Validation Studies

– Internal Clinical Studies resulted in high accuracy sensor performance.
– Developed the algorithm that compensates for patient motion.
Study included in FDA submission for patients over 18.

MODEL 400 PATIENT MONITORING SYSTEM DESIGN & DEVELOPMENT

FDA Clearance | Model 400 Patient Monitoring System

Initial submission for use in adult population cleared.

Developed In-House Manufacturing Capability

2015

2016

Cincinnati Children’s Hospital Study

Pediatric study conducted in support of clearance for all age groups.

FDA Clearance | Use in Pediatric Population

Model 400 Patient Monitoring System Launch

Product availability in the US.

2017

2018

Integration with Philips Intellivue

New software release.

SMARTTOUCH SENSOR DESIGN & DEVELOPMENT

SmartTouch Validation

Clinical Studies

2019

2020

Model400_with_Extension_Module_and_power_brick

SmartTouch FDA Clearance & Product Launch

Our Values

What we stand for and believe in as a company

The values listed below continuously guide us in delivering exceptional solutions to you and your patients. They are the cornerstone of our brand and the elements that make ivWatch the leader in early IV infiltration detection.

Authentic

We believe in the importance of being a genuine part of the patient’s journey. By empathizing with them from admission to discharge, we strive to meet and exceed their needs.

Trustworthy

We are committed to building genuine, long-term relationships with our customers. We will be there when you need us and remain always accountable and committed to you and your patients.

Patient-centric

Everything we do centers around the patient. We live and breathe every aspect of a patient’s experience. We are relentless in prioritizing their needs through innovative design and outstanding service.

Better Together

We believe in partnering with hospitals, clinicians, and patients to improve our technology and advance care. We believe that hospitals and clinicians are heroes; together, we can make patients better.

Our Partnerships

ivWatch, the only provider of continuous monitoring devices for the early detection of intravenous (IV) infiltrations and extravasations, entered into a long-term development and commercialization agreement with ICU Medical, a worldwide leader in the development, manufacture, and sale of innovative medical devices used in infusion therapy and critical care applications. The collaboration will offer a way forward for Electronic Health Records (EHR) interoperability by connecting the two companies’ systems to exchange and use high-quality data.
READ PRESS RELEASE

ivWatch has announced compatibility with Philips IntelliVue Patient Monitors with the inclusion of point-of-connectivity. As the only provider of continuous non-invasive monitoring devices for the early detection of peripheral intravenous (IV) infiltrations and extravasations, ivWatch now supports Philips IntelliVue Patient Monitors for in-room and remote notifications and electronic medical record (EMR) data capture.
READ PRESS RELEASE

ivWatch and Terumo entered into a licensing and distribution agreement to help improve patient safety. As part of the agreement, Terumo Corporation is named as the exclusive distributor for the ivWatch Model 400 in Japan and has licensed the ivWatch OEM board to provide continuous IV infiltration detection technology in Terumo products globally.

ivWatch is the market leader for continuous IV infiltration and extravasation detection technology and Terumo Corporation is one of the world’s leading medical device manufacturers and distributors.
READ PRESS RELEASE

ivWatch, LLC has been awarded a group purchasing agreement for Patient Safety Solutions with Premier, Inc. to provide more than 4,000 U.S. Premier member hospitals and approximately 200,000 other providers and organizations with greater access to the only continuous peripheral IV site monitoring technology available in the market. The three-year agreement underscores the importance of detecting IV infiltration and extravasation events early to advance patient safety and create a new standard of care. Premier members can contact their Premier account manager or contact Sales@ivWatch.com to take advantage of special pricing and terms pre-negotiated for the ivWatch Model 400 system.
READ PRESS RELEASE

ivWatch has been designated a Vizient awarded supplier by Vizient, Inc., the largest member-driven health care performance improvement company in the country. The ivWatch Model 400 has earned an Innovative Technology designation based on recommendations for the device by providers with expertise in this category. Innovative Technology contracts are reserved for technologies that demonstrate an ability to enhance clinical care or patient safety, and those that improve an organization’s care delivery and business model. Vizient-served members can contact their Vizient account manager or access additional information on the ivWatch Model 400 through the Vizient member portal.
READ PRESS RELEASE

ICU Medical

ivWatch, the only provider of continuous monitoring devices for the early detection of intravenous (IV) infiltrations and extravasations, entered into a long-term development and commercialization agreement with ICU Medical, a worldwide leader in the development, manufacture, and sale of innovative medical devices used in infusion therapy and critical care applications. The collaboration will offer a way forward for Electronic Health Records (EHR) interoperability by connecting the two companies’ systems to exchange and use high-quality data.
READ PRESS RELEASE

Philips

ivWatch has announced compatibility with Philips IntelliVue Patient Monitors with the inclusion of point-of-connectivity. As the only provider of continuous non-invasive monitoring devices for the early detection of peripheral intravenous (IV) infiltrations and extravasations, ivWatch now supports Philips IntelliVue Patient Monitors for in-room and remote notifications and electronic medical record (EMR) data capture.
READ PRESS RELEASE

Terumo

ivWatch and Terumo entered into a licensing and distribution agreement to help improve patient safety. As part of the agreement, Terumo Corporation is named as the exclusive distributor for the ivWatch Model 400 in Japan and has licensed the ivWatch OEM board to provide continuous IV infiltration detection technology in Terumo products globally.

ivWatch is the market leader for continuous IV infiltration and extravasation detection technology and Terumo Corporation is one of the world’s leading medical device manufacturers and distributors.
READ PRESS RELEASE

Premier

ivWatch, LLC has been awarded a group purchasing agreement for Patient Safety Solutions with Premier, Inc. to provide more than 4,000 U.S. Premier member hospitals and approximately 200,000 other providers and organizations with greater access to the only continuous peripheral IV site monitoring technology available in the market. The three-year agreement underscores the importance of detecting IV infiltration and extravasation events early to advance patient safety and create a new standard of care. Premier members can contact their Premier account manager or contact Sales@ivWatch.com to take advantage of special pricing and terms pre-negotiated for the ivWatch Model 400 system.
READ PRESS RELEASE

Vizient

ivWatch has been designated a Vizient awarded supplier by Vizient, Inc., the largest member-driven health care performance improvement company in the country. The ivWatch Model 400 has earned an Innovative Technology designation based on recommendations for the device by providers with expertise in this category. Innovative Technology contracts are reserved for technologies that demonstrate an ability to enhance clinical care or patient safety, and those that improve an organization’s care delivery and business model. Vizient-served members can contact their Vizient account manager or access additional information on the ivWatch Model 400 through the Vizient member portal.
READ PRESS RELEASE

Our Distributors

As the exclusive distributor for ivWatch products in the Netherlands, QRS offers local sales, service, support and clinical services for ivWatch in addition to their line of innovative medical devices and disposables.

Evoluzione is the exclusive distributor of ivWatch products in Italy. Specializing in innovative vascular access and patient safety medical devices, Evoluzione provides local sales, service, support and clinical services for the ivWatch product line.

Emitac Healthcare Solutions has partnered with ivWatch to distribute our ground-breaking technology in the United Arab Emirates. As an exclusive ivWatch distributor, Emitac provides the innovative ivWatch Patient Monitoring System, as well as support, service, and clinical services along with their array of superior quality, cost-effective services and solutions to the healthcare community in the UAE.

Tamer Group is a leading distributor of medical equipment and supplies in the Kingdom of Saudi Arabia. Tamer Group leverages their expertise and deep connections in market to distribute ivWatch products and provide in-service training and support.
READ PRESS RELEASE

ivWatch and New Medical enter into international distribution partnership to manage the distribution of the ivWatch Model 400 in Australia and New Zealand. New Medical is a supplier of medical consumables, devices and patient monitoring accessories.
READ PRESS RELEASE

Canadian Health Specialties (CHS) is the exclusive distributor of ivWatch products throughout Canada. CHS is a national specialty distributor of medical and surgical products focused on strategic partnerships that enhance the experience of their customers, while focusing on improving patient outcomes. Partnering with ivWatch extends the CHS portfolio of IV and vascular access solutions focused on patient safety.

ivWatch and Sedeer Medical Services enter into international distribution partnership to manage the distribution of the ivWatch Model 400 in Qatar. Sedeer Medical aims to raise the bar in the field of health care by utilizing state-of-the-art technology, constantly in touch with new breakthroughs and developments.
READ PRESS RELEASE

ivWatch and Terumo entered into a licensing and distribution agreement to help improve patient safety. As part of the agreement, Terumo Corporation is named as the exclusive distributor for the ivWatch Model 400 in Japan and has licensed the ivWatch OEM board to provide continuous IV infiltration detection technology in Terumo products globally. Terumo Corporation is one of the world’s leading medical device manufacturers and distributors.
READ PRESS RELEASE

QRS

As the exclusive distributor for ivWatch products in the Netherlands, QRS offers local sales, service, support and clinical services for ivWatch in addition to their line of innovative medical devices and disposables.

Evoluzione

Evoluzione is the exclusive distributor of ivWatch products in Italy. Specializing in innovative vascular access and patient safety medical devices, Evoluzione provides local sales, service, support and clinical services for the ivWatch product line.

Emitac

Emitac Healthcare Solutions has partnered with ivWatch to distribute our ground-breaking technology in the United Arab Emirates. As an exclusive ivWatch distributor, Emitac provides the innovative ivWatch Patient Monitoring System, as well as support, service, and clinical services along with their array of superior quality, cost-effective services and solutions to the healthcare community in the UAE.

Tamer Group

Tamer Group is a leading distributor of medical equipment and supplies in the Kingdom of Saudi Arabia. Tamer Group leverages their expertise and deep connections in market to distribute ivWatch products and provide in-service training and support.
READ PRESS RELEASE

New Medical

ivWatch and New Medical enter into international distribution partnership to manage the distribution of the ivWatch Model 400 in Australia and New Zealand. New Medical is a supplier of medical consumables, devices and patient monitoring accessories.
READ PRESS RELEASE

Roxon

ivWatch and Roxon medi-tech enter into an international distribution partnership to manage the distribution of the ivWatch Model 400. Roxon medi-tech focuses on supplying quality specialized medical equipment to medical facilities across Canada.
READ PRESS RELEASE

Sedeer

ivWatch and Sedeer Medical Services enter into international distribution partnership to manage the distribution of the ivWatch Model 400 in Qatar. Sedeer Medical aims to raise the bar in the field of health care by utilizing state-of-the-art technology, constantly in touch with new breakthroughs and developments.
READ PRESS RELEASE

Terumo

ivWatch and Terumo entered into a licensing and distribution agreement to help improve patient safety. As part of the agreement, Terumo Corporation is named as the exclusive distributor for the ivWatch Model 400 in Japan and has licensed the ivWatch OEM board to provide continuous IV infiltration detection technology in Terumo products globally. Terumo Corporation is one of the world’s leading medical device manufacturers and distributors.
READ PRESS RELEASE

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