Nihon Kohden NKV-440 Ventilator System Receives US FDA 510(k) Clearance
Today, Nihon Kohden OrangeMed, Inc. received U.S. Food and Drug Administration (FDA) 510(k) clearance for its NKV-440 Ventilator System. The...
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SANTA ANA, California (June 1, 2023)
Nihon Kohden NKV-440 Ventilator System Receives US FDA 510(k) Clearance
Today, Nihon Kohden OrangeMed, Inc. received U.S. Food and Drug Administration (FDA) 510(k) clearance for its NKV-440 Ventilator System. The NKV-440, an turbine-based ventilator, is a “neonatal through adult” platform that provides independence from compressed air while providing high-quality ICU performance in a smaller, more mobile package. The NKV-440 ventilator leverages the same clinician-focused, app-based user interface as the NKV-550 Series Ventilator System.
Reinforcing our commitment to lung protection, the NKV-440 ventilator features our Gentle Lung® Suite of applications: Recruitability Assessment, Recruitment Maneuvers, and PEEP Titration. The NKV-440 ventilator also has a HEPA-filtered turbine and integrated pneumatic nebulization.
“The release of the NKV-440 ventilator, the third ventilator from Nihon Kohden in five years, exemplifies our solid commitment to respiratory solutions,” said Hong-Lin Du, M.D., President of Nihon Kohden OrangeMed. “The NKV-440 ventilator is an obvious choice for hospitals with limited infrastructure while
requiring a feature-rich solution.”
“The release of the NKV-440 ventilator is an exciting step forward in advancing the ventilation portfolio for Nihon Kohden.” Eiichi Tanaka, Head of Nihon Kohden US Operations said. “This furthers our mission to improve the outcomes of our patients through innovative technologies and high-quality medical devices.”
About Nihon Kohden OrangeMed, Inc.
Nihon Kohden OrangeMed, located in Orange County, California, focuses on design, development, and providing state-of-the-art innovative respiratory products distributed throughout the Nihon Kohden worldwide distribution network.
Nihon Kohden OrangeMed is part of Nihon Kohden Corporation headquartered in Tokyo, Japan. Nihon Kohden is one of the leaders in medical device design and manufacturing in the world. Listed on the Tokyo Stock Exchange, Nihon Kohden, with its 5,000 employees, tirelessly pursues to deliver medical technology innovations and high-quality medical products worldwide. Nihon Kohden’s products range from bedside monitors, central monitors, defibrillators, AEDs, physiological measuring equipment, in vitro diagnostic equipment, and mechanical ventilators. Nihon Kohden has superior brand strength with over 70 years of advancing medical care through technological breakthroughs.
Nihon Kohden NKV-330 Ventilator System Receives US FDA 510(k) Clearance
Today, Nihon Kohden OrangeMed, Inc. received U.S. Food and Drug Administration (FDA) 510(k) clearance for its NKV-330 Ventilator System. The...
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SANTA ANA, California (July 1, 2022)
Nihon Kohden NKV-330 Ventilator System Receives US FDA 510(k) Clearance
Today, Nihon Kohden OrangeMed, Inc. received U.S. Food and Drug Administration (FDA) 510(k) clearance for its NKV-330 Ventilator System. The NKV-330 is a non-invasive ventilator that provides respiratory support to adult and pediatric patients. It offers not only non-invasive ventilation but also invasive ventilation as well as high flow oxygen therapy. In addition, it provides continuous monitoring of CO2 when using our cap-ONE® NIV mask. The cap-ONE mask is an NIV interface that allows quality CO2 monitoring directly from the ventilator.
“The NKV-330 ventilator can help hospitals who face a limited choice of new non-invasive ventilator platforms.” said Dr. Hong-Lin Du, CEO of Nihon Kohden OrangeMed. “The continuous monitoring of CO2, the excellent portability, and many other features in the NKV-330 makes it a great choice for the hospitals and caregivers.”
The NKV-330 Ventilator System is distributed in the United States by Nihon Kohden America, Inc. and is expected to begin shipping in July 2022. It has been available outside of the United States since 2019.
For more information on the NKV-330 Ventilator System, please visit www.orange-med.com.
About Nihon Kohden OrangeMed, Inc.
Nihon Kohden OrangeMed, located in Orange County, California, focuses on design, development, and providing state-of-the-art innovative respiratory products distributed throughout the Nihon Kohden worldwide distribution network.
Nihon Kohden OrangeMed is part of Nihon Kohden Corporation headquartered in Tokyo, Japan. Nihon Kohden is one of the leaders in medical device design and manufacturing in the world. Listed on the Tokyo Stock Exchange, Nihon Kohden, with its 5,000 employees, tirelessly pursues to deliver medical technology innovations and high-quality medical products worldwide. Nihon Kohden’s products range from bedside monitors, central monitors, defibrillators, AEDs, physiological measuring equipment, in vitro diagnostic equipment, and mechanical ventilators. Nihon Kohden has superior brand strength with over 70 years of advancing medical care through technological breakthroughs
Nihon Kohden OrangeMed Selected to Develop Ventilator Remote Control Technology
Nihon Kohden OrangeMed, Inc. announced it was selected by U.S. Army’s Telemedicine and Advanced Technology Research Center (TATRC) at the...
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Nihon Kohden OrangeMed Selected to Develop Ventilator Remote Control Technology
SANTA ANA, California (June 22, 2021)
Nihon Kohden OrangeMed, Inc. announced it was selected by U.S. Army’s Telemedicine and Advanced Technology Research Center (TATRC) at the U.S. Army Medical Research and Development Command to develop ventilator remote control technology for the National Emergency Tele-Critical Care Network (NETCCN). The agreement was issued by the Medical Technology Enterprise Consortium (MTEC).
Nihon Kohden will develop such technology leveraging its Protective Control® feature of the NKV-550 ventilator platform. Protective Control is a second graphical user interface outside of the patient room, enabling clinicians to control and monitor the ventilator.
“We are excited to use our technical expertise to support our society in the fight against COVID-19 and other pandemics or natural disasters”, said Hong-Lin Du, MD, CEO of Nihon Kohden OrangeMed. “Protective Control has been widely adopted by hospitals globally during COVID-19 pandemic and is a perfect foundation for us to develop a ventilator remote control technology compatible with the NETCCN.”
The views expressed in this news release/article are those of the authors and may not reflect the official policy or position of the Department of the Army, Department of Defense, or the U.S. Government.
About USAMRDC
The U.S. Army Medical Research and Development Command is the Army’s medical materiel developer, with responsibility for medical research, development, and acquisition. USAMRDC produces medical solutions for the battlefield with a focus on various areas of biomedical research, including military infectious diseases, combat casualty care, military operational medicine, medical chemical and biological defense, and clinical and rehabilitative medicine. https://mrdc.amedd.army.mil/
About TATRC
The Telemedicine and Advanced Technology Research Center (TATRC) is a Provisional Command under the U.S. Army Medical Research and Development Command (USAMRDC), located at Fort Detrick, Maryland. TATRC conducts and supports research through its four key divisions which include: Computational Biology, Digital Health, Medical Modeling & Simulation, and Medical Robotics and Autonomous Systems. TATRC fosters research to address gaps in DoD medical programs and military healthcare. With an extensive network of partners, TATRC expertise is focused on the entire research spectrum, from early stage innovative research to technology demonstrations and implementation to benefit the Warfighter.
About NETCCN
The U.S. Army Medical Research and Development Command’s (USAMRDC) Telemedicine and Advanced Technology Research Center (TATRC) launched NETCCN to address a key challenge during the COVID-19 pandemic: Extending critical care expertise to places that lack ICUs and associated clinical staff. Based on cellular communication networks, mobile technologies and cloud computing, NETCCN teams consist of critical care clinicians and technology partners who are collaboratively developing cloud-based, low-resource, stand-alone health information management systems for the creation and coordination of flexible and extendable “virtual critical care wards.” These rapidly available, high acuity virtual wards bring high-quality critical care capability to nearly every bedside, be it healthcare facilities, field hospitals, or other locations that lack adequate critical care expertise and resources. To date, NETCCN teams have delivered tele-critical care to COVID-19 patients in hospitals and at home in assistance of healthcare organizations in Iowa, Guam, Minnesota, North Dakota, Puerto Rico and South Dakota.
About MTEC
MTEC is a biomedical technology consortium collaborating with multiple government agencies under a 10-year renewable Other Transactional Agreement with the U.S. Army Medical Research and Development Command. MTEC is managed by Advanced Technology International. To find out more about MTEC, visit mtec-sc.org.
Nihon Kohden Begins Shipment of Protective Control®
TOKYO, JAPAN - The Nihon Kohden Group has begun worldwide shipments of the Protective Control® feature for their NKV-550 ventilators. Protective...
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Nihon Kohden Begins Shipment of Protective Control®
August 27, 2020
TOKYO, JAPAN – The Nihon Kohden Group has begun worldwide shipments of the Protective Control® feature for their NKV-550 ventilators. Protective Control is a second user interface placed outside of the isolated patient’s room, in addition to the primary user interface on the ventilator next to the patient inside the room. Clinicians can operate the ventilator through this fully functional second user interface as long as the patient is within the sight of the clinician. This is to help reduce the exposure of clinicians when they care for patients with COVID-19 or other contagious diseases.
The NKV-550 ventilator with Protective Control is the only critical care ventilator, at the time of this press release, that has received US FDA’s 510(k) clearance for this feature, a review process more rigorous than the FDA’s Emergency Use Authorization. A team of engineers, scientists, and clinicians of Nihon Kohden OrangeMed, Inc, the California-based respiratory business unit of Nihon Kohden Group, started development of this technology since 2015 in the wake of SARS, Swine flu and Ebola outbreaks.
“With diseases like COVID-19, caregivers are always looking for ways to minimize exposure to the virus while maintaining the ability to intervene more quickly when the conditions of the isolated patient change,” said Robert Kacmarek, PhD, director of Respiratory Care at the Massachusetts General Hospital of Harvard University and consultant for Nihon Kohden, “This pandemic is a reminder of how important it is to protect our healthcare workers.”
In the US alone, more than 142,000 health workers have been infected by COVID-19 and 660 have died from it [1]. “We are confident this feature will be used by more and more hospitals around the world to provide enhanced protection to clinicians caring for patients with COVID-19 or other contagious diseases”, said Hirokazu Ogino, President and CEO of Nihon Kohden Corporation.
[1] CDC COVID-19: cases in the US. https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/cases-in-us.html. Accessed on August 24, 2020.
Disclaimer: The NKV-550 ventilator has not been registered in, approved for sale in, or available for purchase in all countries or regions.
Please visit the local website for your region.
Nihon Kohden OrangeMed ISO 13485:2016 Certified
Today, Nihon Kohden OrangeMed has received ISO 13485:2016 certification for its quality management system (QMS) following an extensive review by...
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Nihon Kohden OrangeMed ISO 13485:2016 Certified
Today, Nihon Kohden OrangeMed has received ISO 13485:2016 certification for its quality management system (QMS) following an extensive review by DEKRA. An internationally recognized QMS standard, ISO 13485 was specifically developed for medical device companies. Certification indicates a demonstrated ability to design and manufacture quality medical devices that meet customer and regulatory requirements.
NKV-550 Series Ventilator System Receives FDA 510(k) Clearance
Nihon Kohden OrangeMed, Inc. has received U.S. FDA 510(k) clearance for the Nihon Kohden NKV-550 Series Ventilator System. The NKV-550...
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NKV-550 Series Ventilator System Receives FDA 510(k) Clearance
Nihon Kohden OrangeMed, Inc. has received U.S. FDA 510(k) clearance for the Nihon Kohden NKV-550 Series Ventilator System. The NKV-550 Series Ventilator System is a critical care ventilator designed for adult, pediatric or neonatal patients for use in a hospital or hospital-type setting. Ventilation is indicated for use on patients who require respiratory support, such as invasive ventilation, non-invasive ventilation and high flow oxygen therapy.
The NKV-550 Series Ventilator System offers a suite of “Gentle Lung” applications (apps) for clinicians to practice lung protective ventilation more easily and safely. With the patent pending “Protective Control” through a second graphic user interface, it allows clinicians to minimize biological hazard and radiological hazard while caring for patients with contagious diseases and for patients undergoing interventional radiological procedures. With a wide range of therapy types and ventilation modes, clinicians can ventilate a patient from intubated ventilation, to mask ventilation, to high flow nasal cannula, and to mask oxygenation, with the same ventilator without changing breathing circuits. Its app-based approach not only helps the clinicians to optimize their daily workflow, but also makes the additions of new features easier in future.
The NKV-550 was designed by an experienced team in California who Treasure Every Breath©.