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.
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.
SHL Medical | January 24, 2024
SHL Medical, a world-leading solutions provider of advanced drug delivery systems and SteriPack Group, renowned global supplier of secondary packing and final assembly services to the pharmaceutical industry, enter a non-exclusive strategic partnership. Together, they aim to establish a pre-validated final assembly service at the SteriPack facility in Poland, enhancing the overall flexibility of supply chain strategies for their customers. In addition to SHL Medical's existing final assembly, labeling, and packaging services in the United States, this collaboration extends high-quality CMO options to Europe.
Markus Puusepp, SHL Medical's Chief Growth Officer, expressed enthusiasm about the partnership, stating "This partnership is a significant addition to the Molly® platform value proposition. We share common values with SteriPack, from focus on the customer to a commitment to quality, making the decision to collaborate straightforward."
Recognizing the importance of flexibility and time-to-market, especially in clinical production, the partnership with SteriPack will offer SHL Medical's customers highly flexible and personalized final assembly and packaging solutions. This is particularly beneficial for small batch handling in clinical supply and niche markets like rare diseases. Emphasizing the comprehensive capabilities of the Molly platform, SHL Medical aims to deliver right-sized solutions that ensure improved service, faster timelines, and a more streamlined supply chain for its diverse customer base.
John Ward, SteriPack Group's VP Pharmaceutical Solutions commented "SteriPack Group looks forward to supporting SHL Medical and their customers in providing quality and flexible solutions to a fast- moving market. With an emphasis on creating service solutions designed around specific customer requirements, this partnership will make the process of working with the Molly® platform an easy decision."
About SHL Medical
As a world-leading solutions provider of advanced drug delivery systems, SHL Medical is the partner of choice for many leading pharma and biotech companies. Driven by its company purpose – Enabling Patients' Independence – SHL Medical offers patient-centric solutions for the design, development, and manufacturing of autoinjectors, pen injectors, as well as innovative specialty delivery systems for large-volume and high-viscosity formulations. It also offers final assembly, labeling, and packaging solutions for its drug delivery systems.
In response to the rising trend in home therapy, SHL Medical has increased its developmental work in the digital healthcare sector to help improve the drug delivery ecosystem.
Located across Switzerland, Taiwan, Sweden, and the US, SHL Medical's global team of experts collaborate seamlessly as one team in utilizing its comprehensive in-house manufacturing capabilities. Its solutions offer customization and optimization for each project while proactively weaving sustainability-driven measures into its designs and processes to contribute to a cleaner earth.
About SteriPack Group
SteriPack Group is a globally renowned contract packing and manufacturing organisation serving the pharmaceutical and medical device sectors respectively. With a strong emphasis on innovation, quality and compliance, SteriPack's services to the pharmaceutical industry include device design and development, final assembly, labelling, secondary packing, serialisation and aggregation of injectable formats including vials, pre-filled syringes, and autoinjectors.
SteriPack's tailored customer-focused solutions make it an ideally suited supplier for small to medium-sized batch volumes required for a growing market of targeted therapies as well as clinical trials. Its proven capabilities in cleanroom assembly and labelling as well as secondary packing services for drug delivery systems and medical devices, combined with significant investment into growing cold chain storage capacity, have helped to make it a trusted partner to top global pharmaceutical companies.
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.
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.
Keystone Healthcare Partners | February 05, 2024
Keystone Healthcare Partners a leading provider of emergency medicine, hospital medicine, critical care medicine, and telehealth staffing and management services, as well as revenue cycle management, recently announced that it has formed a partnership with Trinity Medical in Ferriday, Louisiana. Keystone's delivery of emergency medicine services at Trinity Medical will commence on February 1, 2024.
This contract represents an exciting expansion of Keystone's regional influence into Louisiana; the company has managed contracts in Mississippi for decades. Glenn Adams, Keystone's CEO & Co-founder, notes, "We are excited to kick off another partnership with a client where we see opportunity for real impact. We've hit the ground running to shore up areas of frustration for the client and bring value-add and innovative solutions, such as Keystone Connect AI technology to the emergency medicine program."
While the healthcare landscape has been challenging for rural and critical access hospitals, the two entities share a patient-centered ethos that will be paramount to the partnership. The two entities share a community- and patient-focus that is embodied by Trinity's motto, "People you know, caring for people you love."
"We are very excited to start our partnership with Keystone Healthcare," states Keisha Smith, CEO of Trinity. "My goal for Trinity Medical has always been to provide our patients with the best healthcare and customer service possible in the Miss-Lou area. We feel that Keystone shares the same goals that we have and will be a true asset to our hospital. Henry Ford stated, 'Coming together is a beginning, staying together is progress, and working together is success.' We are looking forward to a long lasting, successful partnership with Keystone Healthcare."
Trinity Medical, a 23-bed licensed facility, continues to grow and upgrade their services and facilities in addition to recruiting physicians to meet the growing needs of their expanding community.
About Keystone Healthcare
Keystone Healthcare™ is a leading provider of Emergency Medicine, Hospital Medicine, Critical Care Medicine and Telehealth clinical management services and staffing solutions for hospitals. We efficiently deliver high-quality, patient-centered care through strong physician leadership and involved management that drive our innovative and integrated business model.
About Trinity Medical
Trinity Medical is operated by Concordia Parish Hospital Service District No. 1. Trinity Medical, formerly Riverland Medical Center, opened in 1964 as Concordia Parish Hospital and has continuously served the residents of the area for more than 55 years.
In addition to emergency and acute care, Trinity Medical offers surgical services, diagnostic imaging, infusion center, cardio-respiratory care, gastroenterology, lab services, otolaryngology, urology, and an in-hospital rehabilitation service as well as an extensive range of out-patient services, both diagnostic and for treatment.