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Medtronic Diabetes expands CGM offerings to meet more people where they are in their diabetes journey DUBLIN, Aug. 7, 2024 /PRNewswire/ -- Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced the U.S. Food and Drug Administration (FDA) approval for its Simplera™ continuous glucose monitor (CGM) — the company's first disposable, all-in-one CGM that's half the size of previous Medtronic CGMs. The discreet design simplifies the insertion and wear experience, eliminating the need for overtape. The Simplera™ platform featuring the company's newest CGM form factor, includes the Simplera™ CGM, designed to be used as part of a Smart MDI system with the InPen™ smart insulin pen and the Simplera Sync™ sensor, which is designed to be integrated with the MiniMed™ 780G system. The Simplera™ CGM and Simplera Sync™ sensor are CE Marked in Europe and launched earlier this year with positive feedback around ease of use and insertion, adding to the existing high satisfaction with the MiniMed™ 780G system. The recent FDA approval for Simplera™ CGM lays the groundwork for future submission of the updated InPen™ smart insulin pen app, which would facilitate integration with Simplera™ CGM, as a Smart MDI system. Once FDA clearance is obtained, Medtronic will initiate a limited market release in the U.S. beginning with existing standalone CGM and InPen™ customers. The Simplera Sync™ sensor is under review by the FDA in a separate regulatory filing. It is investigational in the U.S. and not approved for commercial use. Additional global regulatory submissions and approvals of the Simplera™ CGM and Simplera Sync™ sensor are pending. Global Partnership to Complement Future Medtronic CGM Offerings Medtronic is excited to announce a global partnership with Abbott to expand CGM options for people living with diabetes. Under this unique agreement, the companies will collaborate on an integrated CGM based on Abbott's most advanced CGM platform. Abbott will supply Medtronic with a CGM that will work exclusively with Medtronic smart dosing devices and software across both automated insulin delivery and Smart MDI systems. These systems, including the Abbott-based CGM, will be sold exclusively by Medtronic. Medtronic expects this original equipment manufacturer (OEM) agreement to be accretive to Diabetes revenue and neutral to Diabetes gross margin. Additional financial terms of the partnership and timing for commercial availability were not disclosed. "Our partnership with Abbott allows us to expand access to our advanced automated insulin delivery and Smart MDI systems that deliver best-in-class outcomes with the most widely used CGM in the world. We look forward to offering our Simplera™ platform alongside this integrated CGM to bring more choice to people living with diabetes within one seamless Medtronic experience," said Que Dallara, executive vice president and president, Medtronic Diabetes. Medtronic continues to advance its pipeline for people requiring intensive insulin delivery, including next-generation durable and patch automated insulin delivery systems, smart pens, CGMs, algorithms, software and services and will continue to expand therapy indications. "This partnership pairs two global leaders in glucose sensing technology and insulin delivery," said Jared Watkin, executive vice president of Abbott's diabetes care business. "Abbott's CGM technology has set the standard for accurate, accessible, easy-to-use and reliable continuous glucose monitoring. Connecting this CGM built for Medtronic's advanced insulin delivery systems and algorithms makes it easier for people to spend less time thinking about their diabetes and more time living." About the Diabetes Business at Medtronic (www.medtronicdiabetes.com)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 MedtronicBold 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 95,000+ 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. For more information on Medtronic, visit www.Medtronic.com and follow Medtronic on LinkedIn. Any forward-looking statements, including, but not limited to, statements regarding the partnership between Medtronic and Abbott, strategic and other potential benefits of the partnership, Abbott's products and product candidates, and other statements about Medtronic managements' future expectations, beliefs, goals, plans or prospects, are subject to risks and uncertainties including, but not limited to, the ability to obtain regulatory approvals, and other risks and uncertainties such as those described in Medtronic's reports and other filings with the Securities and Exchange Commission. Actual results may differ materially from anticipated results. Medtronic cautions investors not to place considerable reliance on the forward-looking statements contained in this press release. These forward-looking statements speak only as of the date of this document, and Medtronic undertakes no obligation to update or revise any of these statements except to the extent required by law. Contacts:Janet ChoPublic Relations+1-818-403-7028 Ryan WeispfenningInvestor Relations+1-763-505-4626
The Prospective Partnership with a Subsidiary of China Mobile, one of the World's Largest Mobile Operator, Underscores DTSS' Achievements in 5G-AI Communications BEIJING, Aug. 6, 2024 /PRNewswire/ -- Datasea Inc. (Nasdaq: DTSS) ("Datasea" or the "Company"), a digital technology company incorporated in Nevada, engaged in innovative businesses in high-tech intelligent acoustics in the United States, and 5G-Artificial Intelligence ("AI") multimodal communication technology in China, today announced that on July 17, 2024, the Company's wholly-owned subsidiary, Heilongjiang Xunrui Technology Co., Ltd. ("Xunrui Technology"), was selected by China Mobile Internet Co., Ltd. ("China Mobile Internet") as a prospective partner in its database of companies (the "Partner Database"), that may be chosen to sign specific project cooperation contracts. China Mobile Internet is a subsidiary of China Mobile, one of the world's largest mobile operator and the largest wireless carrier in China. According to the announcement released on July 8, 2024 by China Mobile Internet regarding choosing prospective partners for the Database, Xunrui Technology will now be able to be selected to undertake specific projects for China Mobile Internet, leveraging the development and application of Datasea's advanced 5G-AI multimodal communication technologies. This collaboration aims to promote the joint development of communications and internet innovations, and has the potential to contribute to future revenue growth for Datasea. Ms. Liu Zhixin, CEO of Datasea, commented, "Our selection as a prospective partner of a China Mobile core subsidiary is a major milestone in our corporate development and a confirmation of our achievements in technological innovation and market expansion. We believe that this opportunity for collaboration will provide new possibilities for growth of our existing businesses, which may enable Xunrui Technology to further broaden its market channels, enhance brand influence, and offer higher quality products and services to a wider range of customers." As a specialized subsidiary of China Mobile, China Mobile Internet is responsible for creating CHBN ("Customer", "Home", "Business" and "New" markets) innovative communication and internet products throughout China. Through its Database, China Mobile Internet selects enterprises to partner with that have project integration capabilities, platform integration capabilities, rapid development capabilities and rapid delivery capabilities. Xunrui Technology, Datasea's subsidiary, with its professional R&D capabilities, customer expansion capabilities, and proven performance in the 5G-AI multimodal communication technology industry, passed the rigorous review of China Mobile Internet. and officially became a member of its Partner Database. This means that Xunrui Technology will have the opportunity to collaborate with China Mobile Internet on specific projects in the future, jointly promoting the development and application of cutting-edge technologies such as 5G, AI, and multimodal communication. Mr. Li, the head of the CHBN project at China Mobile Internet, stated, "We are very excited to establish this relationship with Datasea. Datasea's project integration capabilities, platform integration capabilities, rapid development capabilities, and rapid delivery capabilities in 5G communication and the internet have genuinely impressed us, especially its AI-based 5G multimodal platform, which has the potential to further enhance the product value, service capability, operational capability, and innovation capability of CHBN innovative products. We look forward to specific collaborations with Datasea on a number of innovative projects." About Datasea Inc. Datasea Inc. ("Datasea") is a leading provider of products, services, and solutions for enterprise and retail customers in its innovative industries, Acoustics and 5G-AI multimodal communication, especially focusing on ultrasonic, infrasound and directional sound technology. The Company's advanced R&D technology serves as the core infrastructure and backbone for its products. Its 5G multimodal communication segment operates on a cloud platform based on AI. Datasea leverages cutting-edge technologies, precision manufacturing in its Acoustics business, utilizing ultrasonic sterilization to combat viruses and prevent human infections, and is also developing innovations in directional sound and medical ultrasonic cosmetology. In July 2023, Datasea established a wholly-owned subsidiary, Datasea Acoustics LLC, in Delaware, in a strategic move to mark its global presence. This underlies Datasea's commitment to Acoustics hi-tech and its intent to offer leading edge acoustic products and solutions to the U.S. market. For additional information, please visit: www.dataseainc.com. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934 and as defined in the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as "will", "expects", "anticipates", "future", "intends", "plans", "believes", "estimates", "target", "going forward", "outlook," "objective" and similar terms. Such statements are based upon management's current expectations and current market and operating conditions, and relate to events that involve known or unknown risks, uncertainties and other factors, all of which are difficult to predict and which are beyond Datasea's control, which may cause Datasea's actual results, performance or achievements (including the RMB/USD value of its anticipated benefit to Datasea as described herein) to differ materially and in an adverse manner from anticipated results contained or implied in the forward-looking statements. Further information regarding these and other risks, uncertainties or factors is included in Datasea's filings with the U.S. Securities and Exchange Commission, which are available at www.sec.gov. Datasea does not undertake any obligation to update any forward-looking statement as a result of new information, future events or otherwise, except as required under law. Investor and Media Contacts: Datasea Investor RelationsEmail: investorrelations@shuhaixinxi.com sunhezhi@shuhaixinxi.com Precept Investor Relations LLCDavid Rudnick+1 646-694-8538david.rudnick@preceptir.com
Lancet Digital Health study highlights Lunit INSIGHT CXR as top performer in TB screening, showing promise for improving detection in high-burden settings SEOUL, South Korea, Aug. 6, 2024 /PRNewswire/ -- Lunit, a leading provider of AI-powered solutions for cancer diagnostics and therapeutics, today announced that its AI-powered chest X-ray analysis software, Lunit INSIGHT CXR, has demonstrated superior performance in tuberculosis (TB) detection in a large-scale, independent study published in The Lancet Digital Health. Lunit's AI-powered chest X-ray analysis solution, Lunit INSIGHT CXR Despite being a curable disease, TB remains the world's second leading cause of death from a single infectious agent, with an estimated 10.6 million new cases in 2022. A major challenge in TB control is underdiagnosis, with 3.1 million cases going undetected that year. While chest X-rays are more sensitive than symptom screening, their effectiveness is often limited by variability in human interpretation and a shortage of radiologists in high-burden countries. This context underscores the critical importance of advanced AI assistance. The study, conducted by Dr. Zhi Zhen Qin and a team of researchers from the Stop TB Partnership at UNOPS and Heidelberg University Hospital, evaluated 12 commercially available AI products for TB detection using data from South Africa's national TB prevalence survey. Lunit INSIGHT CXR achieved the highest area under the receiver operating characteristic curve (AUC) of 0.902, significantly outperforming other products. Key findings for Lunit INSIGHT CXR include: Highest AUC (0.902) among all tested products 89.9% sensitivity at 67.7% specificity, meeting WHO target product profile 89.5% sensitivity at 70.2% specificity, meeting WHO target product profile Ability to maintain high sensitivity (>90%) across a wide range of thresholds The study, which included 774 participants (258 bacteriologically confirmed TB cases), is the first to comprehensively evaluate multiple AI products in a high TB setting. "This landmark study not only showcases our AI's superior accuracy but also demonstrates its alignment with WHO standards," said Brandon Suh, CEO of Lunit. "Lunit INSIGHT CXR's ability to maintain high sensitivity across diverse populations and thresholds is particularly crucial in resource-limited settings, where every undetected case can have far-reaching consequences. By bridging the gap in TB diagnosis, we are contributing to a future where no case goes undetected, especially in regions where it matters most." The study's findings have significant implications for TB screening in high-burden settings. Lunit INSIGHT CXR's robust performance, particularly its ability to maintain high sensitivity across various thresholds, allows for tailored screening strategies. This adaptability enables healthcare systems to optimize detection rates while managing available resources for confirmatory testing, potentially leading to more accessible and cost-effective TB programs in diverse healthcare settings. About Lunit Founded in 2013, Lunit is a medical AI company on a mission to conquer cancer. We harness AI-powered medical image analytics and AI biomarkers to ensure accurate diagnosis and optimal treatment for each cancer patient. Our FDA-cleared Lunit INSIGHT suite for cancer screening serves over 3,500 hospitals and medical institutions across 50+ countries. Our clinical findings are featured in top journals, including the Journal of Clinical Oncology and the Lancet Digital Health, and presented at global conferences such as the ASCO and RSNA. In 2024, Lunit acquired Volpara Health Technologies, setting the stage for unparalleled synergy and accuracy, particularly in breast health and screening technologies. Headquartered in Seoul, South Korea, with a network of offices worldwide, Lunit leads the global fight against cancer. Discover more at lunit.io.
TOKYO, Aug. 6, 2024 /PRNewswire/ -- Terumo Corporation (TSE: 4543) today announced that it has established "Terumo Ventures," a Corporate Venture Capital (CVC) organization responsible for leading the Group's venture investments, as a department within Terumo Americas Holding, Inc. Terumo Ventures operates in global innovation hubs around the world, such as Massachusetts and California in the United States, and invests US$ 75 million over the next five years in early-stage companies primarily in the fields of cardiovascular disease treatment, chronic disease treatment, and digital technologies. This will enable Terumo to enhance its access to innovative technologies and business ideas from start-ups, promote open innovation, and pursue synergies with its internal R&D efforts. Terumo has been building relationships with medtech start-ups by investing in venture capital funds in the United States and China since 2013. With the establishment of the CVC, the company will further increase its agility in identifying, evaluating, and executing venture investments, while accelerating the speed of acquiring cutting-edge technologies and developing a robust M&A target pipeline for future growth. With the 5-Year Growth Strategy "GS26" and its long-term vision of "From Devices to Solutions," Terumo is committed to delivering innovative and comprehensive solutions to various medical challenges and unmet needs. As part of this effort, the company has been working to strengthen its innovation capabilities. This includes the introduction of the new director position in charge of innovation in April 2024. The position centrally manages innovation-related functions across the company, such as R&D, intellectual property, clinical development, digital transformation, and venture investment, and facilitates cross-functional collaboration. Going forward, Terumo will continue to enhance its ability to create innovation through a combination of internal development and partnerships with external parties to further expand the value it provides to society. For more information on Terumo Ventures, please visit https://www.terumo.com/terumo-ventures. About Terumo Terumo (TSE:4543) is a global leader in medical technology and has been committed to "Contributing to Society through Healthcare" for 100 years. Based in Tokyo and operating globally, Terumo employs more than 30,000 associates worldwide to provide innovative medical solutions in more than 160 countries and regions. The company started as a Japanese thermometer manufacturer, and has been supporting healthcare ever since. Now, its extensive business portfolio ranges from vascular intervention and cardio-surgical solutions, blood transfusion and cell therapy technology, to medical products essential for daily clinical practice such as transfusion systems, diabetes care, and peritoneal dialysis treatments. Terumo will further strive to be of value to patients, medical professionals, and society at large.
- Exhibited multiplex PCR testing technologies that provide comprehensive results from a single test - Presented high-multiplex assays and automated testing systems - Introduced the SG OneSystem™ business, the company's global technology-sharing initiative SEOUL, South Korea, Aug. 5, 2024 /PRNewswire/ -- Seegene Inc. (KQ096530), a leading South Korean company providing a total solution for PCR molecular diagnostics, showcased its key products and systems at the Association for Diagnostics & Laboratory Medicine 2024 (ADLM 2024) under the exhibition theme "One Sample, Many Answers." The event was held in Chicago from July 30 to August 1. Seegene showcased its multiplex PCR technology products and automated testing systems at the ADLM 2024 held in Chicago, USA, from July 30 to Aug. 1. The company unveiled its lineup of high-multiplex real-time PCR products designed to identify multiple targets in a single test. These assays include IVDR assays sold outside the USA for diagnosing respiratory infections (RP), gastrointestinal tract infections (GI), sexually transmitted infections (STI), human papillomavirus infections (HPV), and antimicrobial resistance (AMR). Seegene's testing process was also displayed on the video screens at the company's exhibition booth. In addition to its flagship assay lineup, Seegene showcased the Seegene STARlet-AIOS™ (AIOS), its automated testing systems, and Seegene NIMBUS, which offer diverse automation solutions tailored to the size and needs of various testing labs. The AIOS features a modular design that seamlessly integrates existing instruments such as nucleic acid extraction equipment, PCR setup, and PCR instruments. The AIOS is designed to automate the PCR testing process, from nucleic acid extraction to gene amplification and data analysis, minimizing the contamination caused by human errors. Once test samples are inserted, the system automatically conducts the tests and delivers results. "The ADLM 2024 was a great opportunity for Seegene to globally promote our proprietary multiplexing PCR technology along with assays and automated testing systems," said Daniel Shin, Executive Vice-President and Chief Global Sales and Marketing Officer at Seegene. "Seegene remains committed to solidifying its position as a global-leading molecular diagnostics company by widely promoting its businesses and actively identifying potential partners to realize 'a world free from all diseases.'" Seegene's PCR molecular diagnostics technology enables simultaneous testing of up to 14 pathogens in a single tube, as well as identifying dozens of key pathogens in a panel testing of multiple tubes. Seegene's PCR testing technology is highly recognized for its ability to provide quantitative information. Multiplex testing reduces the need for additional tests, reducing costs and increasing time-efficiency. The company also hosted business meetings to introduce its long-term business strategy such as the SG OneSystem™ business, the company's technology-sharing initiative, and the Open Innovation Program (OIP), a global reagent development project, to participants from around the world. About Seegene Seegene has 23 years of dedicated R&D, manufacturing, and business experience around multiplex quantitative PCR technologies, which was highlighted during the COVID-19 pandemic when it provided over 340 million COVID-19 tests to more than 100 countries worldwide. The core feature of Seegene's unique syndromic PCR technologies is the ability to simultaneously test 14 pathogens in a single tube and provide quantitative results. About the Association for Diagnostics & Laboratory Medicine (ADLM) Dedicated to achieving better health through laboratory medicine, ADLM (formerly AACC) brings together more than 70,000 clinical laboratory professionals, physicians, research scientists, and business leaders from around the world focused on clinical chemistry, molecular diagnostics, mass spectrometry, translational medicine, lab management, and other areas of progressing laboratory science. Since 1948, ADLM has worked to advance the common interests of the field, providing programs that advance scientific collaboration, knowledge, expertise, and innovation. For more information, visit www.myadlm.org.
TOKYO, Aug. 5, 2024 /PRNewswire/ -- PENTAX Medical, a division of HOYA group, proudly announces FDA clearance of the DEC™ Duodenoscope (ED34-i10T2s) compatibility with the STERRAD™ 100NX Sterilizer, the flagship product from Advanced Sterilization Products (ASP), a division of Fortive. The collaboration between PENTAX Medical and ASP has resulted in a groundbreaking advancement in addressing the ongoing challenges of duodenoscope reprocessing. Reducing the risk of cross-contamination with duodenoscopes has been a point of focus in the joint project. The DEC Duodenoscope (ED34-i10T2s) is the world's first GI endoscope compatible with hydrogen peroxide gas plasma sterilization, a technology that has revolutionized infection prevention across various medical specialties. "The low, but persistent risk of duodenoscope contamination post-reprocessing emphasizes the need for a reliable sterilization solution," said Klaus Mergener, MD, PhD, MBA, Global Head, Medical & Scientific Affairs and Chief Medical Officer at PENTAX Medical. "The partnership between PENTAX Medical and ASP has produced a method that also considers the workflow aspects that matter just as much as meeting sterilization efficacy standards." FDA clearance of the ED34-i10T2s duodenoscope represents PENTAX Medical's second pioneering milestone in enhancing infection prevention and patient safety through innovative design. The launch of the DEC (Disposable Elevator Cap) marked the first medical device manufacturer's response to the FDA's and CDC's call for advancement in duodenoscope design to reduce the risk of cross-contamination. The DEC allows physicians to simply and safely dispose the elevator, the component most vulnerable to enteric bacteria, while maintaining image quality, performance and handling of a reusable duodenoscope in each procedure. "The collaboration with ASP marks a pivotal step forward in our continued effort to enhance patient safety through innovative endoscope designs; the compatibility with STERRAD technology ensures easier access to sterilized duodenoscopes with a lower environmental impact" said Harald Huber, Chief Product Officer at PENTAX Medical. About PENTAX MedicalPENTAX Medical is a division of HOYA Group. The company's mission is to improve the standard of patient care and quality of healthcare delivery by providing the best endoscopic products and services with a focus on QUALITY, CLINICALLY RELEVANT INNOVATION, and SIMPLICITY. PENTAX Medical strives to align with the healthcare community's Triple Aim goals through transparent partnerships with its customers and by providing the highest quality solutions to help them reach their goals, including enabling customers to improve patient outcomes by offering evidence-based solutions across the continuum of care; ensuring value by supporting the customers to improve their efficiency and minimize their healthcare costs; and enriching patient and provider's experience by empowering every member of the care team to achieve optimal outcomes through products, education, and support. Focused on the outcome instead of technological features, PENTAX Medical listens to the healthcare community and their patients, understands their daily obstacles and helps improve endoscopy with smart innovations. For more information: https://www.pentaxmedical.com About HOYAFounded 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 is active in the fields of lifecare and information technology, providing eyeglasses, medical endoscopes, intraocular lenses, optical lenses, as well as key components for semiconductor devices, LCD panels, and hard disk drives. With over 150 offices and subsidiaries worldwide, HOYA currently employs a multinational workforce of 37,000 people. For more information, please visit: https://www.hoya.com/en/
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