In the News

ivWatch Inks Distribution Deal with Terumo
September 29, 2017

ivWatch has recently signed a licensing and distribution agreement with Terumo to improve patient safety, according to a Sept. 21 press release. Terumo will become the exclusive distributor of the ivWatch Model 400 and ivWatch OEM board in Japan. ivWatch technology can be integrated with other patient monitoring systems, infusion pumps and other devices easily with the ivWatch OEM board. The agreement also allows Terumo to exclusively integrate ivWatch into existing and future Terumo products in Japan.
Read the full article here.

ivWatch President and CEO Invited to Judge Pediatric Device Competition

Gary Warren, ivWatch President & CEO, will join the Review Committee of the Atlantic Pediatric Device Consortium (APDC) Pediatric Device Innovation Competition. The Pediatric Device Innovation Competition is a seed grant competition that provides an opportunity for the scientific and business community including entrepreneurs, clinicians, scientists, businesses, academic researchers and medical and engineering graduate and undergraduate students, to develop and commercialize a pediatric medical device. Grants are expected to range from $5,000 to a maximum of $50,000 for one year.

Mr. Warren has extensive executive experience in developing and managing high-growth technology and venture-backed private companies with a focus on product management and delivery in small start-up companies, large public companies, and government programs. For the past seven years, Mr. Warren has been with ivWatch , the market leader in developing, commercializing and distributing non-invasive sensor technology to monitor a patient’s IV site for complications. The company’s flagship product, the ivWatch Model 400, is an FDA-cleared stand-alone continuous monitoring system that allows clinicians to manage the risk of IVs by providing early detection of infiltration and extravasation. Reliable early detection of infiltrations and extravasations, when fluid leaks outside of the vein, is necessary to help hospitals manage the risks associated with this common invasive procedure.

The APDC is an FDA funded consortium based out of Georgia Tech, Emory University, Children’s Healthcare of Atlanta, and Virginia Commonwealth University that provides a national platform to translate medical device ideas from concept to commercialization.  APDC’S mission is to enhance the lives of children through the development of novel pediatric medical devices, which are both safe and effective.  The consortium provides an environment of creativity, where ideas are reviewed, tested, and developed.

As part of the review committee, Mr. Warren will assess the proposals on a number of factors including: 1) clinical significance of the pediatric device, 2) approach to product development, 3) likelihood for marketing success, 4) project team, environment, and resources, and 5) potential for additional funding. Project presentations take place today, Monday, September 25, 2017 on the Virginia Commonwealth University (VCU) campus with notification of awards announced on October 30, 2017.

About APDC
The Atlantic Pediatric Device Consortium (APDC) is one of seven FDA funded pediatric device consortia awarded in 2013.  A collaboration between Georgia Tech, Emory University, Children’s Healthcare of Atlanta and Virginia Commonwealth University, APDC provides a national platform to translate ideas through its product development pathway all the way to commercialization. The mission of APDC is to enhance the lives of children through the development of novel pediatric medical devices, which are both safe and effective. Since 2011 the Consortium has created an environment of creativity, where innovative ideas are reviewed, tested and developed and it reflects the long term commitment of our partner institutions. Success is measured by the development, production and marketing of several novel pediatric medical devices.
http://atlanticpediatricdeviceconsortium.org/projects

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.

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

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.

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