Medical Devices
Medtronic | January 08, 2024
Medtronic plc a global leader in healthcare technology, today announced CE (Conformité Européenne) Mark approval for the MiniMed™ 780G system with Simplera Sync™, a disposable, all-in-one continuous glucose monitor (CGM) requiring no fingersticks or overtape. Simplera Sync™ features an improved user experience with a simple, two-step insertion process and is half the size of previous Medtronic sensors.
The MiniMed 780G system with Simplera Sync™ sensor will be available in Europe via limited release in spring 2024. Medtronic will begin the phased commercial launch in Europe in the summer of 2024. Today, the MiniMed™ 780G system can be used with the Guardian™ 4 sensor.
The MiniMed™ 780G system is Medtronic's most advanced insulin delivery system, automatically adjusting and correcting† glucose levels every 5 minutes.§ It's the world's only system with a Meal Detection™ feature‡ that is designed to reduce post-meal hyperglycemia when users occasionally forget to give themselves insulin or underestimate the number of carbs in their snacks or meal. The system, which is available with the world's only 7-day infusion set, also features one of the lowest glucose target settings (as low as 100 mg/dL) of any automated insulin delivery system. With this "treat to target" approach, the system more closely mirrors the glucose levels of someone not living with diabetes. With both Simplera Sync™ sensor and the Guardian™ 4 sensor, no fingersticks are required.
"A challenging aspect of living with diabetes is counting carbohydrates and dosing the right amount of insulin before consuming snacks and meals. Many people underestimate their carbs, which can lead to high blood sugars (hyperglycemia). Prolonged hyperglycemia can lead to serious health problems impacting the eyes, major organs, and even cognitive function, which is particularly concerning in developing children," Robert Vigersky, M.D., Chief Medical Officer, Medtronic Diabetes, Professor of Medicine, Uniformed Services University of the Health Sciences "With its responsive algorithm, the MiniMed™ 780G system can help people living with diabetes even when they occasionally forget to bolus or undercount their carbs. The system takes on more of the work involved in diabetes management and helps alleviate mental burden."
"We're incredibly proud that the MiniMed™ 780G system continues to be the most widely used automated insulin delivery system in Europe since we launched it in 2020. Real-world data on over 100,000 users on the system across many geographies and cultures shows that when using recommended settings the system is delivering an average Time in Range of nearly 80%, raising the bar on what 'good' looks like2," said Que Dallara, EVP and President, Medtronic Diabetes. "With the introduction of Simplera Sync™ sensor, we're able to offer the proven benefits of our MiniMed™ 780G system with our newest and most comfortable sensor that can be applied in under 10 seconds."
The MiniMed™ 780G system with Simplera Sync™ sensor is indicated for ages 7+ and compatible with iOS and Android. Simplera Sync™ sensor is not approved by the FDA and is limited to investigational use in the U.S.
Simplera Sync™ sensor is designed to leverage Medtronic's advanced AID algorithm as part of its MiniMed™ 780G system while having a similar look and feel as the Simplera™ CGM. The Simplera™ CGM for integrated use with the InPen™ smart insulin pen received CE Mark in September 2023.
About the Diabetes Business at Medtronic
Medtronic Diabetes is on a mission to alleviate the burden of diabetes by empowering individuals to live life on their terms, with the most advanced diabetes technology and always-on support when and how they need it. We've pioneered first-of-its-kind innovations for over 40 years and are committed to designing the future of diabetes management through next-generation sensors (CGM), intelligent dosing systems, and the power of data science and AI while always putting the customer experience at the forefront.
About Medtronic
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Dublin, Ireland, is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 90,000+ passionate people across more than 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary.
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Digital Healthcare, Medical Devices
Mindray North America | January 12, 2024
Mindray, a global developer of technologies and solutions for patient monitoring, anesthesia, and ultrasound, announced a five-year agreement with WakeMed Health & Hospitals (WakeMed), a leading health system in Raleigh, N.C. The nationally recognized 970-bed not-for-profit health care system selected Mindray's intuitive patient monitoring systems—including the BeneVision Distributed Monitoring System (DMS) and BeneVision N-series Patient Monitoring Systems—for its three hospitals.
As part of the agreement, approximately 2,300 monitoring devices will be installed in WakeMed's emergency and inpatient areas, across all acuity levels, to help assess and facilitate patient care, monitor vitals and condition changes in real-time, and provide seamless data integration during patient transport throughout its facilities.
"We are very excited to collaborate with WakeMed," stated Wayne Quinn, President, Mindray North America. Wayne continued, "Our purpose is to provide our customers with progressive technology that helps them deliver the highest quality care now and in the future, aligning with a shared vision of better healthcare for all. The contract with WakeMed underscores our commitment to ensuring the health system has access to tools and technologies that enable clinicians to work more efficiently while helping WakeMed fulfill its mission to improve the health and well-being of their community by providing outstanding and compassionate care to all."
"Mindray's monitoring technology will allow us to further improve patient safety, efficiency and clinical workflow as we continue to deliver life-changing care," said Neal Chawla, MD, Chief Medical Information Officer (CMIO) for WakeMed. "Alongside comprehensive patient monitoring, these innovative tools help prevent alarm fatigue and create a quieter, more restful environment for patients—a critical element to promote healing."
The BeneVision N-Series consists of six monitors with the same user interface. It allows healthcare facilities to choose their ideal display size and parameter capabilities, putting precise, relevant data at clinicians' fingertips. As the first-ever patient monitoring platform to incorporate capacitive touch screen technology across all of its monitors, N-Series enables clinicians to cut minutes off of clinical review, analysis and charting time, leading to increased efficiencies and driving positive patient outcomes. The N-Series' modular design expands, providing a scalable solution and the ability to flex from low acuity to high acuity, seamless data integration during transport, and flexible licensing options.
Mindray's BeneVision DMS provides continuous, real-time access and surveillance across large and small healthcare networks and integrates and displays patient information from networked bedside monitors, vital signs monitors, wireless transport solutions, and telemetry transmitters – supporting up to 1,200 devices across the enterprise, locally, and remotely. The BeneVision DMS enables clinicians to observe, manage and document a patient's condition in support of high-quality, patient-centric care, from admission to discharge.
About Mindray
Mindray is a leading developer, manufacturer, and supplier of medical device solutions and technologies used in healthcare facilities around the globe. We believe we can change lives by making the most advanced healthcare technology attainable for all. We do this by empowering healthcare professionals through innovative, high-value solutions that help create the next generation of lifesaving tools across three primary business segments: medical imaging, patient monitoring and life support, and in-vitro diagnostics. Mindray maintains its global headquarters in Shenzhen, China; Mindray North America is headquartered in Mahwah, New Jersey. Our Ultrasound Innovation Center is located in Silicon Valley, with additional facilities in major international markets around the world.
About WakeMed Health & Hospitals
Serving the community since 1961, WakeMed is a not-for-profit health care system founded and based in Raleigh, N.C. WakeMed exists to improve the health and well-being of our community by providing outstanding and compassionate care to all. WakeMed's 970-bed system comprises a network of facilities throughout the Triangle area, including three full-service hospitals, seven emergency departments, a dedicated Children's Hospital and Rehabilitation Hospital, more than 90 physician offices and Wake County's only Level I Trauma Center. WakeMed's mission-driven team includes more than 10,300 employees, 1,400 volunteers and 1,300 affiliated physicians, along with the more than 700 physicians and providers with WakeMed Physician Practices – all representing the best minds and the biggest hearts and the finest quality in health care and community health.
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Health Technology
Beckman Coulter Diagnostics | January 30, 2024
Beckman Coulter Diagnostics, a clinical diagnostics leader, will unveil its new DxC 500 AU Chemistry Analyzer, an automated clinical chemistry analyzer, at Medlab Middle East in Dubai, taking place February 5-8, 2024. The DxC 500 AU Chemistry Analyzer is one of several recent Beckman Coulter solutions designed to address the complete needs of healthcare systems that are looking to complement central hub laboratories by advancing the technology and capabilities of satellite and independent hospital laboratories.
"Healthcare systems around the world are strategically adopting hub-and-spoke models for better efficiency and healthcare access," said Kathleen Orland, Senior Vice President, Business Unit, General Manager, Chemistry and Immunoassay for Beckman Coulter Diagnostics. "Hub-and-spoke clinical laboratory models optimize resources to improve access to testing services and enhance overall standardization for quality testing and positive impact on inventory and cost management across a health system. The new DxC 500 AU Chemistry Analyzer advances capabilities of spoked labs with a broad menu of high-quality assays that deliver consistent, commutable results across Beckman Coulter's AU clinical chemistry systems, positively impacting clinical decision-making and patient outcomes."
The DxC 500 AU Chemistry Analyzer features advanced automation technology, onboard guided workflows, and standardized reagents for use across healthcare networks. Its menu of more than 120 assays has been independently and objectively verified for high quality Six Sigma performance, supporting confidence in clinical results, reducing QC trouble shooting and lab operational costs.
"Our Six Sigma assessment has shown that the DxC 500 AU analyzer easily exceeds the demands of the new, more stringent CLIA 2024 performance specifications," stated Sten Westgard, Director of Client Services and Technology for Westgard QC.
The DxC 500 AU Chemistry Analyzer is for in vitro diagnostic use only. It is available throughout North America and the Middle East. Global commercial availability is planned for March 2024.
About Beckman Coulter. Inc.
A global leader in advanced diagnostics, Beckman Coulter has challenged convention to elevate the diagnostic laboratory's role in improving patient health for more than 80 years. Our mission is to Relentlessly Reimagine Healthcare, One Diagnosis at a Time – and we do this by applying the power of science, technology and the passion and creativity of our teams. Our diagnostic solutions are used in complex clinical testing, and are found in hospitals, reference laboratories and physician office settings around the globe. We exist to deliver smarter, faster diagnostic solutions that move the needle forward from what's now to what's next. We seek to accelerate care with an extensive clinical menu, scalable lab automation technologies, insightful clinical informatics, and optimize lab performance services. Headquartered in Brea, Calif., with more than 11,000 global team members, Beckman Coulter Diagnostics is proud to be part of Danaher. Danaher is a global science and technology leader. Together we combine our capabilities to accelerate the real-life impact of tomorrow's science and technology to improve human health.
©2024 Beckman Coulter. All rights reserved. Beckman Coulter, the stylized logo, and the Beckman Coulter product and service marks mentioned herein are trademarks or registered trademarks of Beckman Coulter, Inc. in the United States and other countries.
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Digital Healthcare
UCI Health | February 02, 2024
The Regents of the University of California, on behalf of the University of California, Irvine, has entered into a definitive agreement with Tenet Healthcare Corporation to acquire Tenet's Pacific Coast Network. The network will become part of UCI Health, the clinical enterprise of UC Irvine.
"UC Irvine has deepened its healthcare commitment to the future of Orange County, our region and California," said UC Irvine Chancellor Howard Gillman. "This journey in healthcare is deeply intertwined with the University of California's dedication to bettering our communities, expanding access to premier healthcare, and pioneering the medical innovations of tomorrow, today. Our vision will bridge gaps in regional care and reinforce UCI's place among the nation's leading academic health systems while advancing solutions to challenges facing healthcare."
Pending customary regulatory approvals, clearances, and closing conditions, the proposed acquisition would bring four medical centers in Lakewood, Los Alamitos, Fountain Valley and Placentia and associated outpatient locations into the UCI Health system. UCI Health currently delivers care at UCI Medical Center in Orange and a growing network of multispecialty care centers.
"At UCI Health, we are excited to add these new care sites to the UCI Health network and extend the benefits of our compassionate, high-level care, clinical innovation, and scientific discovery," said Chad Lefteris, president and chief executive officer of UCI Health. "As Orange County's only academic health system, UCI Health is unique in its ability to offer the highest level of advanced care powered by the research and innovation of a world-class public research institution."
UCI Health recognizes a unique opportunity to build on the quality care already being delivered in the communities served by Tenet Healthcare's Pacific Coast Network.
"These four hospitals are well-regarded in their communities for providing high-quality, compassionate care," said Saum Sutaria, M.D., chairman and chief executive officer of Tenet Healthcare. "The local communities will benefit from the nationally recognized advancements, medical knowledge, research, and community focus that UCI Health brings as an innovative academic health system. UCI Health recognizes a unique opportunity to build on the quality care already being delivered in the communities served by the Pacific Coast Network."
In a region with a population greater than that of two dozen states, UCI Health operates the only Level I trauma center, locally based National Cancer Institute-designated comprehensive cancer center, high-risk perinatal-neonatal service and is the largest regional burn center and leading provider of complex tertiary and quaternary care. The system's clinical excellence has consistently placed UCI Health in the top 10 for quality and safety among the nation's leading comprehensive academic health systems.
The acquisition also means more patients will have access to advanced therapies in the region's largest and most diverse portfolio of clinical trials, ranging from cancer to neurosciences, digestive diseases, orthopedics and internal medicine specialties.
UCI Health and Tenet Healthcare's Pacific Coast Network patients can continue receiving care at their local facilities as they normally would from the care teams they know and trust. The transaction is expected to be completed in spring 2024, subject to customary regulatory approvals, clearances, and closing conditions.
"It is a privilege to provide world-class care to Californians and we are excited to welcome the clinicians and co-workers from these Tenet Healthcare sites to UCI Health as partners in improving the health of local communities," Lefteris said.
About UCI Health
UCI Health is the clinical enterprise of the University of California, Irvine, and the only academic health system in Orange County. Patients can access UCI Health at primary and specialty care offices across Orange County and at its main campus, UCI Medical Center in Orange, Calif. The 459-bed, acute care hospital, listed among America's Best Hospitals by U.S. News & World Report for 23 consecutive years, provides tertiary and quaternary care, ambulatory and specialty medical clinics, behavioral health and rehabilitation services. UCI Medical Center is home to Orange County's only National Cancer Institute-designated comprehensive cancer center, high-risk perinatal/neonatal program and American College of Surgeons-verified Level I adult and Level II pediatric trauma center, gold level 1 geriatric emergency department and regional burn center.
About UC Irvine
About the University of California, Irvine: Founded in 1965, UCI is a member of the prestigious Association of American Universities and is ranked among the nation's top 10 public universities by U.S. News & World Report. The campus has produced five Nobel laureates and is known for its academic achievement, premier research, innovation and anteater mascot. Led by Chancellor Howard Gillman, UCI has more than 37,000 students and offers 224 degree programs. It's located in one of the world's safest and most economically vibrant communities and is Orange County's second-largest employer, contributing $7 billion annually to the local economy and $8 billion statewide.
About Tenet Healthcare
Tenet Healthcare Corporation is a diversified healthcare services company headquartered in Dallas. Our care delivery network includes United Surgical Partners International, the largest ambulatory platform in the country, which operates or has ownership interests in more than 480 ambulatory surgery centers and surgical hospitals. We also operate 58 acute care and specialty hospitals, approximately 110 other outpatient facilities, a network of leading employed physicians and a global business center in Manila, Philippines. Our Conifer Health Solutions subsidiary provides revenue cycle management and value-based care services to hospitals, health systems, physician practices, employers, and other clients. Across the Tenet enterprise, we are united by our mission to deliver quality, compassionate care in the communities we serve.
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