Nonin Medical, Inc. announced the CO-Pilot Wireless Handheld MultiParameter System (H500) received 510(k) clearance from the U.S. FDA. The CO-Pilot is a handheld device with wireless capabilities that helps EMS, firefighters and military personnel measure patient parameters following cardiac arrest, traumatic injury, carbon monoxide or smoke inhalation. The CO-Pilot offers reliable readings to allow for improved patient care in an ambulance, at the scene of a fire, or any emergency setting before arrival at a hospital.

co-pilot, 8330aa, multi parameter, measurements

The CO-Pilot simultaneously tracks patient pulse oximetry (SpO2), pulse rate, carboxyhemoblin (COHb) and methemoglobin (MetHb). Cerebral and tissue oximetry (rSO2) can be measured using an additional sensor.

“During our clinical study of the CO-Pilot (H500) we found it to be portable and extremely easy to use. The ability to track a multitude of parameters was beneficial and provided critical information for patient care,” said Guillaume Debaty, M.D., Ph.D., an emergency medicine physician at Grenoble Alpes University Hospital and the head of SAMU de l’Isère in Grenoble, France. “We also believe the technology has great potential for the management of cardiac arrest patients.”

One important feature of the CO-Pilot is the ability to measure brain and tissue oxygenation when administering CPR to patients who experience out-of-hospital cardiac arrest (OHCA). A study by the American Heart Association estimates that 326,200 OHCAs occur in the U.S. each year. On average 10.6% of people survive and 8.3% survive with good neurologic function.1 The CO-Pilot provides tissue oximetry data to track decreases in tissue oxygenation, which is a critical metric for survival and brain function. In addition, the

CO-Pilot can assist in the clinical assessment of carbon monoxide poisoning allowing first responders to make treatment decisions at the scene or on the way to a hospital.

“Since 1986 when Nonin advanced pulse oximeter technology, the company has set the standard for innovation and accuracy,” said Dave Hemink, CEO, Nonin Medical. “The CO-Pilot is another Nonin industry first that leverages wireless technology to give first responders potentially life-saving patient data to decide on treatment options during the golden hour.”

With CO-Pilot, first responders can reliably measure SpO2, pulse rate, COHb, MetHb and rSO2 even in the most challenging conditions. This cutting-edge technology allows first responders to focus on care of their critically ill patients.

About Nonin Medical

Since 1986, Nonin Medical has developed reliable technologies and manufactured durable noninvasive patient monitoring devices for healthcare professionals and consumers. Nonin pulse oximeters, cerebral and tissue oximeters, capnographs, sensors, and software deliver dependable performance day after day—even in challenging environments.

Euclid® Medical Products, a leading provider of pharmacy automation equipment, announces the debut of Vantage Vision MDM 1 and MDM 2, a line of verification machines that automatically check multi-dose medication pouches quickly and accurately

Vantage TM Vision MDM 1 is designed for retail and smaller closed-door pharmacies and hospitals wanting to verify medication pouches to reduce the time-consuming process of manual verification. The conveniently sized vision system has fully integrated software which will confirm the size, shape and color of each pill in the pouch package.

The MDM 1 Series records images of each pouch and will flag suspect pouches for further verification. Verifying up to 45 pouches per minute, the MDM 1 Series is perfect for pharmacies looking to streamline the verification process. VantageTM Vision MDM 2 is a larger-scale model designed for pharmacies running multiple packaging machines speeds. The MDM2 can verify up to 75 pouches per minute.

“When it comes to automation, manual verification can be a very time-consuming process,” said Kevin Copsey, Business Unit Director for Euclid® Medical Products. “Introducing Vantage TM Vision MDM 1 and MDM 2 into our product lineup was a natural product line expansion to complement our new line of next generation Axial® multi dose adherence pouch packaging machines.”

To reduce false positives in the pouch verification process, both machines in the Vantage TM Vision line come equipped with an agitator, a mechanism for ensuring pills are sitting flat in the pouch. This agitator technology, which is patented, along with highly sophisticated software algorithms, greatly reduces the likelihood of receiving false positives.

Smart functions in the software allow for a user-friendly interface and process flow. Reports can be printed or exported, and any repaired pouches can be registered by capturing a new image at the Repair Station. Through various processes, the software enables pharmacists to link data to a specific bar code, even after the medication pouches have left the pharmacy.

For more than 40 years, Euclid® Medical Products has offered complete solutions for those looking for easy-to-use unit- and multi-dose packaging and barcoding systems that will stand the test of time. The packaging machines and automated systems are designed to increase operational efficiencies, decrease costs and ensure patient safety.

About Euclid® Medical Products
For more than 40 years, Euclid® Medical Products has been a trusted partner for pharmacies, long-term care facilities and third-party re-packagers seeking high-quality, efficient unit dose or multi-dose packaging and barcoding systems. With a customizable software offering linear and 2D barcoding capabilities, as well as fade-resistant thermal transfer printing, Euclid® provides a complete solution for those looking for easy-to-use systems that will stand the test of time while providing the updated features and technology needed today.

Medtronic plc, the global leader in medical technology, announced the start of a prospective, observational, global, multi-center, real-world, post-market study to evaluate the safety and effectiveness of the Valiant Navion™ Thoracic Stent Graft System in the treatment of thoracic aortic dissection. The first patient procedure in the DISSECT-N study was performed at Northwell Health in New York, New York by Derek Brinster, M.D., director of Aortic Surgery.

“Treatment of aortic dissection is often challenging, especially as patients with fragile aortas have different needs. The Valiant Navion CoveredSeal configuration, designed with fragile aortic tissue in mind, can be especially helpful in treating this condition,” said Ross Milner, M.D., director of the Center for Aortic Diseases at the University of Chicago Medicine in Chicago and U.S. principal investigator for the DISSECT-N study. “I believe the DISSECT-N study — one of the larger prospective aortic dissection repair studies, which includes independent core-lab imaging review — will offer critical contemporary insights about TEVAR use in patients with various types of thoracic aortic dissection.”

The DISSECT-N study will enroll at least 200 patients with an acute or chronic thoracic aortic dissection across approximately 45 sites in North America, Europe, and Asia Pacific. The primary endpoint is composite safety and effectiveness, including technical procedure success and freedom from major adverse events (MAEs) reported up to one month following the index procedure. Patients will be followed for three years. Primary investigators are Dr. Milner and Robin Heijmen, M.D., Ph.D., cardiothoracic surgeon at St. Antonius Hospital in the Netherlands.

“Thoracic aortic dissection is dangerous, with some cases leading to severe internal bleeding or irreversible organ damage; with the Valiant Navion system, more patients with aortic dissection are eligible for thoracic endovascular aneurysm repair (TEVAR),” said Dr. Heijmen, European principal investigator for the DISSECT-N study. “I am pleased to support the generation of real-world evidence in this landmark study, which I believe will help enable the clinical community to optimally treat patients with thoracic aortic dissection using this technology.”

“There remains a significant clinical unmet need in treating thoracic dissection, and we are dedicated to improving the care for these patients through an endovascular approach,” said John Farquhar, vice president and general manager of the Aortic business, which is part of the Cardiac and Vascular Group at Medtronic. “With the DISSECT-N study, we hope to further support the Valiant Navion system as a less invasive approach to treating this condition.”

The low-profile Valiant Navion system received U.S. Food and Drug Administration approval in October 2018, CE Mark in November 2018, and approval from the Ministry of Health, Labour and Welfare (MHLW) in Japan in September 2019.

An aortic dissection is a serious condition in which the inner layer of the lower aorta is torn, causing the inner and middle layers of the aorta to separate (dissect). If the blood-filled channel ruptures through the outside aortic wall, aortic dissection is often fatal.1 About two-thirds of people who have an aortic dissection are male, and those with high blood pressure or high cholesterol may be at greater risk.2

In collaboration with leading clinicians, researchers, and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services of the highest quality that deliver clinical and economic value to healthcare consumers and providers around the world.

About Medtronic
Medtronic plc, headquartered in Dublin, Ireland, is among the world’s largest medical technology, services and solutions companies – alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 90,000 people worldwide, serving physicians, hospitals and patients in approximately 150 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.

Optimum Healthcare IT, a Best in KLAS healthcare staffing and consulting services firm, announced that the firm had been awarded the implementation of the Epic electronic health record (EHR) system at OU Medicine Inc. (OUMI) and OU Health Sciences Center (OUHSC), the flagship academic health system of Oklahoma. OUMI & OUHSC will deploy the full suite of Epic across its entire enterprise, facilitating communication and the exchange of patient records across its three hospitals, physician groups, and medical school. Optimum has the experience of EHR planning and implementation with over 100 partners, and brings this experience and our diverse team to all our clients– helping to apply lessons learned and avoid common pitfalls of such a significant initiative.

Optimum was selected to be the implementation partner after a competitive request for proposal (RFP) process and a long history of successful projects similar in scope. The EHR implementation will transition OUMI & OUHSC from multiple EHR’s to the Epic platform. Optimum will be providing advisory, Epic implementation leadership, project management, and staff augmentation resources to ensure a successful implementation. The tools and accelerators used by Optimum, have been refined over many years and implementation projects. These tools augment Epic’s core tools, hastening initial start-up, increasing efficiency throughout the project, and integrating lessons learned.

Optimum Healthcare IT understands that in healthcare, the EHR is the essential piece of technology used to provide care to patients. If not implemented correctly, both the quality of care and the financial stability of an organization can be at risk. Whether you are a large multi-facility IDN, an Academic Medical Center, a single hospital, or a physician network, our on-site executive leadership team can lead you through a successful implementation.

About OU Medicine
OU Medicine — along with its academic partner, the University of Oklahoma Health Sciences Center — is the state’s only comprehensive academic health system of hospitals, clinics, and centers of excellence. With 11,000 employees and more than 1,300 physicians and advanced practice providers, OU Medicine is home to Oklahoma’s largest physician network with a complete range of specialty care. OU Medicine serves Oklahoma and the region with the state’s only freestanding children’s hospital, the only National Cancer Institute-Designated Stephenson Cancer Center, and Oklahoma’s flagship hospital, which serves as the state’s only Level 1 trauma center. OU Medicine’s mission is to lead healthcare in patient care, education, and research. To learn more, visit oumedicine.com.

About Optimum Healthcare IT
Optimum Healthcare IT is a Best in KLAS healthcare IT staffing and consulting services firm based in Jacksonville Beach, Florida. Optimum provides world-class professional staffing services to fill any need as well as consulting services that encompass advisory, EHR implementation, training and activation, EHR optimization, community connect, managed services, enterprise resource planning, security, and ancillary services – supporting our client’s needs through the continuum of care. Our organization is led by a leadership team with extensive experience in providing expert healthcare staffing and consulting solutions to all types of organizations.

Abbott announced that the U.S. FDA has approved the company’s next-generation Gallant™ implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices. The devices bring new benefits to patients with heart rhythm disorders, including a patient-preferred design without compromising battery longevity and MRI compatibility.  In addition, the new devices offer Bluetooth technology and a new patient smartphone app for improved remote monitoring, allowing for increased patient/physician engagement and streamlined communications.

It is estimated that as many as 6.1 million people in the United States battle cardiac arrhythmias, or abnormal heart rhythms,¹ and ICDs are used to help reduce the risks of life-threatening arrhythmias. For patients with heart failure or in situations when the heart’s chambers beat out of sync, CRT-Ds can be used to restore the heart’s natural pattern of beating.

We are focused on developing and delivering life-changing technologies that impact patient care in a meaningful way,” said Randel Woodgrift, senior vice president, Cardiac Rhythm Management, Abbott. “The Gallant devices are the latest example of how Abbott is driving innovation to meet changing healthcare needs and helping to improve connectivity and engagement between patients and their doctors.”

The new Gallant system pairs with Abbott’s secure myMerlinPulse™, an iOS- and Android™- compatible mobile smartphone app that helps streamline communication between doctors and their patients. The app provides people with access to data, device performance, and transmission history, which helps them take an active role in their healthcare. Through the myMerlinPulse app, physicians can continuously monitor their patients remotely allowing for identification of asymptomatic episodes as well as patient-triggered transmissions, which can lead to earlier intervention and reduce clinical burden.

“The ability for patients to stay connected to their doctors via their implanted device and a smartphone app has the potential to change how healthcare providers and patients communicate with each other,” said Raffaele Corbisiero, M.D., FACC, director of electrophysiology and pacing at Deborah Heart and Lung Center, Browns Mills, N.J. “The FDA’s approval of Abbott’s Gallant devices enables doctors to provide a more collaborative approach to treatment plans and the increased bond between a patient and provider will lead to better outcomes for all.”

About Abbott
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 107,000 colleagues serve people in more than 160 countries.

HOYA Corporation and Hitachi, Ltd. announced a five year contract regarding Endoscopic Ultrasound Systems Hitachi will continue supplying diagnostic ultrasound systems and ultrasound sensor related parts used in EUS.

EUS consists of a diagnostic ultrasound system and ultrasound flexible endoscopes, and is used for examinations to evaluate the cancer staging in the liver, pancreas and bronchus. PENTAX Medical is a division of HOYA Group delivering endo-imaging solutions.

Hitachi’s diagnostic imaging-related business is expected to be transferred to FUJIFILM Corporation, subject to customary closing conditions and regulatory approvals, and this agreement will be valid after such transfer.

Gerald Bottero, Global President of Pentax Medical, HOYA Corporation, stated, “We are honored to continue our alliance with Hitachi which began with joint research in 1983 leading to the first commercial launch of our EUS in 1990. The Hitachi ultrasound technology is globally recognized as an important standard in EUS with high-quality imaging, advanced software modalities, and ease of use.  We look forward to working with Hitachi’s world-class research teams to accelerate innovation and wide adoption in this vital space.

Toshihiko Kawano, CTO of Healthcare Business Unit, Hitachi, Ltd. said, “It is our pleasure to keep continuing the business relation of EUS with PENTAX Medical Division, HOYA Corporation. Hitachi and PENTAX Medical have been working together for more than 30 years and developing innovative technologies in EUS. We look forward to collaborating in the future and exploring new clinical values to provide for better diagnosis and treatment.”

About HOYA

Founded in 1941 in Tokyo, Japan, HOYA Corporation is a global technology and med-tech company and a leading supplier of innovative high-tech and medical products. HOYA’s divisions and business units research and develop products utilized in the healthcare and information technology fields. In the healthcare field, we provide medical device products such as eyeglasses, medical endoscopes, contact and intraocular lenses, orthopedic implants, surgical/therapeutic devices and medical device reprocessing and disinfection solutions.  In the information technology field, we provide products such as optical lenses, photomasks and blanks used in the manufacturing process for semiconductor and LCD/OLED devices, text to speech, human resources and other software solutions and critical components for the mass memory and cloud storage industries. With over 150 offices and subsidiaries worldwide, HOYA currently employs a multinational workforce of 37,000 people.

About Hitachi, Ltd.

Hitachi, Ltd., headquartered in Tokyo, Japan, is focused on its Social Innovation Business that combines information technology (IT), operational technology (OT) and products. The company’s consolidated revenues for fiscal year 2019 (ended March 31, 2020) totaled 8,767.2 billion yen ($80.4 billion), and it employed approximately 301,000 people worldwide. Hitachi drives digital innovation across five sectors – Mobility, Smart Life, Industry, Energy and IT – through Lumada, Hitachi’s advanced digital solutions, services, and technologies for turning data into insights to drive digital innovation. Its purpose is to deliver solutions that increase social, environmental and economic value for its customers.