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.

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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.

ivWatch Achieves ISO 13485 Certification: Provides Foundation for International Distribution

HAMPTON, Va. — August 15, 2017 — ivWatch LLC, a medical device company focused on improving the safety and effectiveness of intravenous (IV) therapy, today announced receipt of its ISO 13485 Certification, the global standard for medical device quality management systems (QMS) developed by the International Organization for Standardization (ISO®).

“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 OEM Board and FDA-cleared ivWatch Model 400,” says 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 to more hospitals across the U.S. and around the world.”

To achieve this important certification, ivWatch demonstrated that all of its activities and processes conform to both the ISO® standard and the current good manufacturing practices required by international medical device regulations. The company completed a pre-assessment readiness review, followed by a thorough four-day, stage two audit, conducted by TÜV SÜD, an accredited and internationally-recognized certification body. ivWatch passed this comprehensive stage two audit with zero (0) findings; a major accomplishment for any medical device company.

ivWatch is the leader in developing, commercializing and distributing non-invasive sensor technology to monitor a patient’s IV site for complications. 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. The ivWatch technology is also available to OEMs for integration into existing infusion and patient monitoring products. Reliable early detection of infiltrations and extravastions is a requirement to help hospitals manage the risks associated with this common invasive procedure.

The International Organization for Standardization is the world’s largest developer and publisher of international standards for the implementation of quality management systems. EN ISO 13485:2012 + AC:2012 certifies that the ivWatch QMS aligns with the requirements of the Canadian Medical Device Regulations (CMDR), the European Union’s Medical Device Directive (MDD) and other regulatory requirements found throughout the world.

ivWatch recent announcements include closing $14.8 million in its latest round of funding and receiving top honors in the 2017 MDEA competition.

About ivWatch
ivWatch LLC is a medical device manufacturer 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

ivWatch Wins Top Honors at 2017 Medical Design Excellence Awards


HAMPTON, Va. — June 14, 2017 — ivWatch LLC, a medical device company focused on improving the safety and effectiveness of intravenous (IV) therapy, is pleased to announce it was the Bronze Winner last night in the category of Nonsurgical Hospital Supplies and Equipment at the 2017 Medical Design Excellence Awards (MDEAs), the premier awards program for the medtech industry. The award was presented by Medical Device and Diagnostics Industry magazine at the Jacob K. Javits Center in New York during MD&M East, the largest annual medical technology conference on the East Coast for the medical manufacturing industry.

“It’s an honor for ivWatch to be recognized by the MDEA judges for the outstanding design of our device,” said Gary P. Warren, ivWatch president and CEO. “IV infiltration is a major problem for the medical community as it can lead to serious medical complications and even amputation. Our team of employees, partners and suppliers are committed to solving this problem, and have worked tirelessly to make a significant impact in minimizing patient harm from infiltrations.”

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.

MDEA is the medtech industry’s premier manufacturing design competition, recognizing the highest caliber of commercially available products approved by the FDA or other regulating bodies. These awards celebrate the achievements of medical device manufacturers, their suppliers, and the teams behind the scenes who provide input and dedication to innovative products, further improving patient safety across healthcare today.

About ivWatch
ivWatch LLC is a medical device manufacturer focused on improving patient safety and the effectiveness of intravenous therapy. With the Model 400, which is similar to continuous monitors available for a patient’s heart, blood oxygen level and pulse, 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 customers deliver a higher level of patient care and to reduce risks related to IV therapy. 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 is not an FDA-cleared device. It is the responsibility of the Original Equipment Manufacturer integrating ivWatch technology to secure the proper regulatory clearance.

In the News


27 Winners Announced at the 19th Annual Medical Design Excellence Awards (MDEA) Award Ceremony
Winners selected for groundbreaking work in the medical technology field

NEWS PROVIDED BY
UBM Americas 
Jun 13, 2017, 17:58 ET
NEW YORK, June 13, 2017 /PRNewswire/ — The Medical Design Excellence Awards (MDEA), recognizing the technological achievements of medical device manufacturers, announced the 2017 winners at its annual awards ceremony on the evening of June 13. Produced by the Medical Device and Diagnostic Industry (MD+DI), the MDEAs have recognized innovation in medical product design and engineering. Awards are granted across nine categories, announcing gold, silver and bronze medal winners in each category, in addition to naming the best in show and revealing the 2017 readers’ choice winner.

Read the full press release.

In the News

Hampton-based ivWatch receives a $14.8 million round of funding
By Sandra J. Pennecke 
Jun 9, 2017

Gary Warren would like to type IV infiltration into a search engine in 10 years and find that the horrible images are all gone.

Warren, president and CEO of ivWatch LLC, a medical device firm based in Hampton, is working hard to solve the problems that occur when an IV infiltrates.

Infiltration occurs when fluid or medication leaks into the surrounding tissue and can be caused by improper placement or dislodgment of the IV. Read the full article.

Original article published in Inside Business on June 9, 2017.

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