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.

In the News

ivWatch snags $14M+ for IV-monitoring device
by Amirah Al Idrus 
Jun 9, 2017

ivWatch, which markets a device that continuously monitors patients receiving intravenous lines, raised $14.8 million, which will boost its marketing and “strategic partner” activities.

Most hospital patients are given an IV line that delivers nutrients, fluid or medication. But the failure rate due to infiltration, or leakage, is estimated at more than 20%, according to ivWatch. Leakage of fluid or drugs into the surrounding tissue could result in complications as serious as tissue necrosis and amputation. Read the full article.

Original post published in FierceBiotech on June 9, 2017.

In the News

ivWatch raises $14.8m for infusion therapy tech
JUNE 7, 2017 by Sarah Faulkner

ivWatch said today that it closed a $14.8 million financing round to support the company’s direct go-to-market initiatives and strategic partners activities.

Undisclosed angel investors, family funds and a major hospital system invested in the round, according to the company.

“The support ivWatch has seen from our investors and partners has been incredible. They are committed to seeing our technology, research, science and team make a true impact on the problems related to peripheral IV failure,” president & CEO Gary Warren said in prepared remarks. “The momentum we are finding in the market is exciting, as healthcare providers see the benefits of improved patient safety and reduced risks associated with IV therapy.” Read the full article.

Original post published in Drug Delivery Business News on June 7, 2017.

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