In the News

ivWatch Enters Into Licensing and Distribution Agreement With Terumo to Help Improve Patient Safety


September 21, 2017

ivWatch, LLC, the market leader for continuous IV infiltration and extravasation detection technology, today announced that Terumo Corporation, one of the world’s leading medical device manufacturers and distributors, is the exclusive distributor of the ivWatch Model 400 and the ivWatch OEM board in Japan, and is a global licensing partner for Terumo products containing the ivWatch OEM board. **

“We have partnered with ivWatch because they offer the most advanced technology to help minimize patient harm through the early detection of IV infiltration events,” said Tsuyoshi Tomita, group manager, General Hospital Products Group, General Hospital Company at Terumo Corporation. “We are confident that the ivWatch technology will help hospitals improve patient safety by reducing the harm caused by IV infiltration.”

Read the full article here.

ivWatch Enters into Licensing and Distribution Agreement with Terumo to Help Improve Patient Safety

Terumo Corporation named exclusive distributor for ivWatch in Japan, licenses ivWatch continuous IV infiltration detection technology for use in its products globally.

September 21, 2017 – HAMPTON, VA – ivWatch, LLC, the market leader for continuous IV infiltration and extravasation detection technology, today announced that Terumo Corporation, one of the world’s leading medical device manufacturers and distributors, is the exclusive distributor of the ivWatch Model 400 and the ivWatch OEM board in Japan, and is a global licensing partner for Terumo products containing the ivWatch OEM board.**

“We have partnered with ivWatch because they offer the most advanced technology to help minimize patient harm through the early detection of IV infiltration events,” said Tsuyoshi Tomita, group manager, General Hospital Products Group, General Hospital Company at Terumo Corporation. “We are confident that the ivWatch technology will help hospitals improve patient safety by reducing the harm caused by IV infiltration.”

IV therapy is the most common invasive hospital procedure worldwide. A recent study, conducted at a university hospital in Tokyo, Japan, found that catheters failed at a rate of 18.8 percent with 41.3 percent of those failures due to infiltration.(1) Every failure of an IV results in a drug delivery error and carries the potential for reduced drug efficacy and physical harm.

“We are excited to partner with Terumo to help advance patient safety in Japan and on a global scale,” said Gary P. Warren, president and CEO of ivWatch, LLC. “Through the distribution of the ivWatch Model 400 and future integration of the ivWatch OEM board with Terumo products, Terumo will be able to help their customers deliver a higher level of patient care and reduced risks related to IV therapy. This partnership furthers our collective goal of ending the harm associated with IV infiltration and extravasation.”

IV infiltration and extravasation is a major problem as it can lead to serious medical complications and even amputation. The ivWatch Model 400 continuously monitors a patient’s peripheral IV for evidence of infiltrations and extravasations, which occur when medication or fluid leaks into the surrounding tissue. Early detection of those failures via ivWatch sensor technology helps to minimize injuries associated with this common complication of IV therapy.

ivWatch technology can be seamlessly integrated with patient monitoring systems, infusion pumps and other devices via the ivWatch OEM board. The agreement provides Terumo with exclusive rights to integrate ivWatch into existing and future Terumo products in Japan. In addition, Terumo can integrate ivWatch technology into products available globally.

About Terumo:
Tokyo-based Terumo Corporation is one of the world’s leading medical device manufacturers with over $5 billion in sales and operations in more than 160 nations. Founded in 1921, the company develops, manufactures and distributes world-class medical devices including products for use in cardiothoracic surgery, interventional procedures and transfusion medicine; the company also manufactures a broad array of syringe and hypodermic needle products for hospital and physician office use. Terumo contributes to society by providing valued products and services to the health care market and by responding to the needs of health care providers and the people they serve. Terumo Corporation’s shares are listed on the first section of the Tokyo Stock Exchange (No. 4543, Reuters symbol , or Bloomberg 4543: JP) and is a component of the Nikkei 225, Japan’s leading stock index.

Terumo Corporation – 2-44-1 Hatagaya, Shibuya-ku, Tokyo, Japan. http://www.terumo.com

About ivWatch:
ivWatch, LLC is a medical device manufacturer and biosensor technology company focused on improving patient safety and the effectiveness of intravenous therapy. ivWatch provides a first-of-its-kind, FDA-cleared, noninvasive medical device that continuously monitors peripheral IVs for infiltration and extravasation events. The ivWatch Model 400 aims to help eliminate patient harm associated with adverse events and to reduce drug delivery errors. The ivWatch OEM Board integrates ivWatch technology into existing products, enabling OEMs to help healthcare providers deliver a higher level of patient care and to reduce risks related to IV therapy.

The ivWatch OEM Board is not an FDA-cleared device. It is the responsibility of the Original Equipment Manufacturer integrating ivWatch technology to secure the proper regulatory clearance. Follow us on Twitter@ivWatch or Facebook @ivWatchLLC. www.ivWatch.com

MEDIA CONTACT: Leah Moore, leah.moore@ivwatch.com, Office (855) 489-2824 x7031, Mobile (757) 839-5653

**The ivWatch OEM Board integration and ivWatch Model 400 will be available internationally pending the necessary regulatory approvals.

(1) J Infus Nurs. 2017 Jul/Aug;40(4):224-231. doi: 10.1097/NAN.0000000000000168.

In the News

Monitoring devices for IVs
August 29, 2017

ivWatch LLC, which offers continuous monitoring devices for the early detection of peripheral IV infiltrations, has been awarded an Innovative Technology contract from Vizient, Inc.

The device can help in early detection of peripheral IV infiltration and extravasation events.

The Innovative Technology contracts are reserved for technologies that demonstrate an ability to enhance clinical care or patient safety, Vizient said.

The ivWatch Model 400 continuously monitors a patient’s peripheral IV for evidence of infiltrations, which occur when medication or fluid leaks into the surrounding tissue.

Read the full article here.

In the News

ivWatch ISO 13485 certification opens the door for international distribution
By Sandra J. Pennecke
Aug 28, 2017, 5:00 PM EST

ivWatch, LLC has achieved a certification that will allow it to reach even further in its efforts to help hospitals improve the safety and effectiveness of intravenous therapy.

The Hampton-based medical device manufacturing company, which was founded in 2010, created a technology that helps clinicians manage the risks associated with IV therapy through early detection.

In mid-August, it achieved its International Organization for Standardization – ISO 13485 certification – which is the global standard for medical device quality management systems.

ivWatch completed a pre-assessment readiness review and a four-day audit to earn the certification.
The certification will allow ivWatch to open up international distribution for its ivWatch Model 400, aimed at helping eradicate injury to patients by monitoring for evidence of infiltration and the ivWatch OEM Board, a technology that incorporates ivWatch into existing products.

Read the full article here.

ivWatch Awarded New Innovative Technology Contract from Vizient, Inc.

HAMPTON, Va., August 29, 2017– ivWatch, LLC, the leading provider of continuous monitoring devices for the early detection of peripheral IV infiltrations, announced it has been awarded an Innovative Technology contract from Vizient, Inc. the largest member-driven health care performance improvement company in the country.

The Innovative Technology contract was awarded to ivWatch based on recommendations for the ivWatch Model 400 device by providers with expertise in this category who serve on one of Vizient’s member-led councils. 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.

The ivWatch Model 400 continuously monitors a patient’s peripheral IV for evidence of infiltrations, which occur when medication or fluid leaks into the surrounding tissue. Intravenous therapy is a routine part of treatment for nearly 80 percent of patients in the U.S., yet more than 20 percent of these IVs may fail because of infiltration, risking both a serious drug delivery error and tissue damage. Earlier detection of those failures, via ivWatch sensor technology, is the new and next step in minimizing this potential for injury.

“The Innovative Technology contract gives Vizient’s diverse membership a simple and more affordable means for adopting continuous IV monitoring and validates the excitement we’ve seen in hospitals across the country about our unique technology,” said Gary Warren, president and CEO of ivWatch, LLC. “IV infiltration is a major problem that can lead to serious medical complications and even amputation. This contract with Vizient is one more step towards our vision of eliminating the harm associated with IV infiltrations.”

“Due to the number of products and services being released and marketed as ‘innovative,’ member hospitals truly value the thorough innovative technology review process in place at Vizient to help them identify products worth further evaluation at their own facilities,” said Debbie Archer, director of procurement and leader of Vizient’s Innovative Technology program for suppliers. “After a full review of the ivWatch Model 400, Vizient’s member council agreed this solution offers unique and incremental benefits over other products available on the market today, and recommended it for an Innovative Technology contract. We are pleased to award this new contract to ivWatch.”

Vizient, Inc. represents the combined strengths of the organizations formerly known as VHA Inc., University HealthSystem Consortium, Novation and MedAssets’ Spend and Clinical Resource Management. Since 2003, nearly 2200 new and innovative products and technologies have been submitted through the Vizient Innovative Technology program. Vizient works with member-led councils and task forces to identify and review potentially innovative products. If it is determined that a product is innovative, a contract may be awarded outside of Vizient’s competitive bid cycle.

###
MEDIA CONTACT: Leah Moore, leah.moore@ivwatch.com, Office (855) 489-2824 x7031, Mobile (757) 839-5653

In the News

IV therapy device company recognized
By Michele Canty
Aug 25, 2017, 7:00 PM ET

ivWatch LLC received its ISO 13485 certification by the International Organization for Standardization, the Hampton company announced in August. The medical device company focuses on improving the safety and effectiveness of intravenous therapies.

“This is an important milestone for ivWatch, as it validates our commitment to quality and verifies the high standards we follow in the design, development, and manufacturing of the new ivWatch model,” said Mike Gahan, vice president of operations at ivWatch. “Obtaining this ISO certification firmly establishes our solid foundation for future growth and we look forward to bringing better, safer IV procedures.”

Read the full article here.

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