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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Health Technology
Axxess | January 23, 2024
Axxess, the leading global technology innovator for healthcare at home, launched a new product called Axxess Connect, a groundbreaking interoperability solution. This new product will revolutionize the way Axxess users connect and share data with healthcare providers and specialists, further enhancing care coordination, improving patient outcomes and driving the future by enabling new care models and value-based care.
"Axxess Connect is a new benchmark for interoperability in healthcare," says Tim Ingram, Executive Vice President of Interoperability at Axxess. "By working with our partner Kno2 we can now connect our solutions to help accelerate the exchange of health information securely across any network. This means our clients will have easier access to a broader range of providers and specialists, making data sharing and referrals more efficient."
By being Kno2 Connected™, Axxess Connect, enables the secure, effortless, and maximized exchange of patient information across patients, providers, payers and HIT vendors. The solution meets data security and compliance requirements in accordance with HITRUST and HIPAA regulation for privacy, data sharing and healthcare communication standards supported by national and regional frameworks including Direct Trust, Carequality and most recently, TEFCA. This ensures that patient data is interoperable, secured and protected when shared across systems.
"Our collaboration with Kno2 not only improves the overall experience for our users, but it also reduces the administrative load on healthcare providers," said Ingram. "By minimizing time spent on administrative tasks, our clients can focus more on providing quality patient care."
Added Theresa Bell, Co-founder, President and Chief Technology Officer of Kno2: "By seamlessly connecting Axxess users with healthcare providers and specialists, we are breaking down barriers and revolutionizing the way data is shared in every care setting. Axxess Connect represents the power of the partnership and the value of being Kno2 Connected. Together, we are revolutionizing care delivery and thoughtfully solving healthcare's biggest problems."
Axxess Connect will first be available to Axxess Palliative Care clients before eventually being rolled out to the entire Axxess suite of solutions for home health, hospice and home care.
About Axxess
Axxess is the leading global technology innovator for healthcare at home, focused on solving the most complex industry challenges. Trusted by more than 9,000 organizations that serve more than 5 million patients worldwide, Axxess offers a complete suite of easy-to-use software solutions that empower home health, home care, hospice, and palliative providers to make healthcare in the home human again. Multiple independent certifications have confirmed that Axxess has the most secure and industry-compliant software available for providers. The company's collaborative culture focused on innovation and excellence is recognized nationally as a "Best Place to Work."
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Healthcare Analytics
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.
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Healthcare Analytics
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.
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