👉 Meet us live at the #DGK Annual Meeting! Our CCO Harald Kuhlmann will be attending the DGK - German Society of Cardiology Annual Meeting #DGK2024 at the Rosengarten in Mannheim this week, from today to Friday April 5th, 2024. Harald is eager for engaging discussions, in-person meetings, and experiencing the dynamic interfaces of medical and economic realms in #Cardiology. This year's theme, "Interfaces of Cardiovascular Medicine," delves not only into interdisciplinary aspects but should also explore the interface between medicine and economics, e.g. in terms of Market Access and Reimbursement. #Cardiology thrives on innovcation! Whether in the #pharmaceutical, #MedicalDevice or #diagnostics industry, every year many companies with great new products are looking for market entry and commercial success in Europe. From the intricate workings of the heart to navigating complex market landscapes, there's a synergy that drives progress and success. inspiring-health GmbH understands the importance of navigating these intersections. We help manufacturers chart their course through the complexities of #MarketAccess & #reimbursement in #Germany and across #Europe, offering strategic insights, guidance, and support. Join us for a conversation at the conference! We're excited to exchange ideas and explore the possibilities together. Connect with Harald Kuhlmann and let's embark on this journey towards innovation and success! #Inspiring_Health #DGK #DGKAnnualMeeting Image source: Shutterstock / Leonid Andronov
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European and USA Reimbursement for Pharmaceutical, Biotech, and Digital Health through national and regional payers.
🌍 The Future of Diagnostics in Europe: Are We Ready? 🌍 As the medical world strives to stay ahead in innovation and patient care, the EU’s In Vitro Diagnostic Regulation (IVDR) is a bold step forward. But, as with any significant change, it’s not without its challenges. In a compelling paper by Denis Horgan, and colleagues, published in Clinical Chemistry and Laboratory Medicine, we get an in-depth look at the hurdles we are facing. The paper reveals a stark reality: while the IVDR is designed to protect and innovate, the journey to fully implement it is fraught with obstacles that could potentially disrupt patient care across Europe. 🚨 Why should you care? Knowledge Gap: There’s a worrying lack of awareness about #IVDR among those on the front lines—healthcare providers, labs, and manufacturers. This gap threatens to undermine the very safety the regulation seeks to ensure. Regulatory Delays: Notified bodies are overwhelmed. Critical diagnostics are at risk of being delayed, or worse, not approved in time to meet patient needs. Innovation at Risk: The stringent requirements, while essential, could stifle the creativity and drive of small and medium-sized enterprises (SMEs) that are at the heart of medical innovation. 💡 The Call to Action: We need to act—now! The paper calls for urgent collaboration between regulators, industry leaders, and healthcare professionals to overcome these challenges. If we don’t, we risk not only slowing down innovation but also compromising patient care across Europe. This is a critical moment for everyone involved in healthcare and diagnostics. Let’s work together to ensure that the IVDR not only protects but also propels us into a future of safer, more effective diagnostics. European Cancer Patient Coalition #HealthcareRevolution #IVDR #Diagnostics #Innovation #EUHealthcare #PatientFirst #MedicalAdvances Denis Horgan, Ph.D*, Mario Plebani, Matthias Orth, Elizabeth Macintyre, Stan Jackson, , France Dube, Marta K., Birute Tumiene, Roberto Salgado, Jack Schalken, Ettore Capoluongo and Marta Carnielli British In Vitro Diagnostics Association (BIVDA) AdvaMedDx SIDIV Fenin, Federación Española de Empresas de Tecnología Sanitaria Assobiomedica IVD Australia Ltd
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Join Conformal and Industry leaders at #CRT2024 this weekend for cutting-edge insights and advances in the Cardiovascular industry. On Saturday 9, at 5:00 PM: Explore the future with William Gray, MD., as he presents Conformal Self-Adaptable LAA Closure Device: Initial Clinical Experience." Take this chance to be at the forefront of innovative cardiovascular solutions. Then, on Sunday 10, at 3:24 PM, Dive deep into comparative thrombogenicity with William Gray, MD., as he presents "Comparative Acute Thrombogenicity Of The CLAAS Foam Implant And Watchman FLX In An In Vitro Blood Loop Model." Finally, on Tuesday, 13, at 10:39 AM, Aaron Kaplan, MD, will discuss "Conformal: Design and Clinical Data on a Novel LAA Closure Device." Gain insights into a revolutionary LAA closure device's meticulous design and clinical outcomes. See you there! To learn more about the CONFORM Pivotal Trial and the CLAAS System, visit https://lnkd.in/exyWTx-x #Cardiology #LAAO #data #conformalmedical #claas #Afib #CRT2024 #CardioTech #InnovationInTheHeartOfDC #ConformalMedica #interventionalcardiology CAUTION: Investigational Device The CLAAS System is limited by Federal (or United States) law to investigational use.
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🔹 IN CONVERSATION with Dr. Simon Graindorge 🔹 2024 is shaping up to be a pivotal year for OncoRes Medical. As we advance our innovative technology, generating robust evidence that supports regulatory approval and demonstrates our positive impact on patients is a top priority. In the first installment of our In Conversation series, OncoRes’ Chief Operating Officer, Dr. Simon Graindorge, provides insights into our current clinical trials, timelines for key milestones, and our commitment to fostering medical device innovation in Australia. Take a look 👉 https://lnkd.in/gZ45F4v7 #OncoRes #medtech #innovation #breastcancer #breastconservation #breastconservationsurgery #lumpectomy #patientsfirst #patientoutcomes
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🌍 The Future of Diagnostics in Europe: Are We Ready? 🌍 As the medical world strives to stay ahead in innovation and patient care, the EU’s In Vitro Diagnostic Regulation (IVDR) is a bold step forward. But, as with any significant change, it’s not without its challenges. In a compelling paper by Denis Horgan, and colleagues, published in Clinical Chemistry and Laboratory Medicine, we get an in-depth look at the hurdles we are facing. The paper reveals a stark reality: while the IVDR is designed to protect and innovate, the journey to fully implement it is fraught with obstacles that could potentially disrupt patient care across Europe. 🚨 Why should you care? Knowledge Gap: There’s a worrying lack of awareness about #IVDR among those on the front lines—healthcare providers, labs, and manufacturers. This gap threatens to undermine the very safety the regulation seeks to ensure. Regulatory Delays: Notified bodies are overwhelmed. Critical diagnostics are at risk of being delayed, or worse, not approved in time to meet patient needs. Innovation at Risk: The stringent requirements, while essential, could stifle the creativity and drive of small and medium-sized enterprises (SMEs) that are at the heart of medical innovation. 💡 The Call to Action: We need to act—now! The paper calls for urgent collaboration between regulators, industry leaders, and healthcare professionals to overcome these challenges. If we don’t, we risk not only slowing down innovation but also compromising patient care across Europe. This is a critical moment for everyone involved in healthcare and diagnostics. Let’s work together to ensure that the IVDR not only protects but also propels us into a future of safer, more effective diagnostics. European Cancer Patient Coalition #HealthcareRevolution #IVDR #Diagnostics #Innovation #EUHealthcare #PatientFirst #MedicalAdvances Denis Horgan, Ph.D*, Mario Plebani, Matthias Orth, Elizabeth Macintyre, Stan Jackson, , France Dube, Marta K., Birute Tumiene, Roberto Salgado, Jack Schalken, Ettore Capoluongo and Marta Carnielli British In Vitro Diagnostics Association (BIVDA) AdvaMedDx SIDIV Fenin, Federación Española de Empresas de Tecnología Sanitaria Assobiomedica IVD Australia Ltd
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🌟 Gearing Up for TCT 2024: Advancing Cardiovascular Innovation 🌟 As we approach this year's Transcatheter Cardiovascular Therapeutics (TCT) conference, I can't help but feel energized by the tremendous strides being made in MedTech innovation. TCT 2024 will be an incredible showcase of how engineering and clinical science converge to enhance patient outcomes. I’m particularly excited to dive deep into how the integration of AI, big data, and precision medicine is transforming cardiovascular care. This year’s agenda highlights the future of medtech innovation, with a focus on complex coronary interventions, heart valve therapies, and next-gen technologies for managing hypertension and heart failure. 👉 Swipe through my carousel below to preview the key themes from TCT 2024. #MedTech #TCT2024 #CardiovascularInnovation #MedicalDevices #R&D #ProductManagement #AIinHealthcare #PrecisionMedicine #HeartValveTherapies #RenalDenervation #HypertensionTreatment #IntegerHoldings
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**Only put off until tomorrow what you are willing to die having left undone** **Significant Progress in Ocular Therapeutix's SOL-1 Trial for AXPAXLI™ in Wet AMD** Ocular Therapeutix, Inc. has made noteworthy strides in its Phase 3 SOL-1 trial for AXPAXLI™, a promising treatment aimed at combating wet age-related macular degeneration (AMD). With over 300 patients successfully randomized, Ocular Therapeutix is making remarkable progress in this registrational trial. Wet AMD is a leading cause of vision loss, affecting millions of individuals worldwide. Ocular Therapeutix's investigational treatment, AXPAXLI™, holds immense potential in addressing this debilitating condition. By successfully randomizing such a significant number of patients, the company is moving closer to advancing the treatment landscape for wet AMD. As an experienced Investment Advisor, I urge you not to miss out on this breakthrough opportunity. Investing in healthcare and innovative solutions like AXPAXLI™ can yield substantial returns while also contributing to the advancement of medical science. By leveraging your Health Savings Account (HSA), you can not only grow your wealth but also support your health, your family, and overall well-being. Take action now to ensure you're not left behind. Invest in your future and embrace the possibilities of improved healthcare. Avoid the Fear Of Missing Out (#FOMO) by seizing this chance to make a positive impact. Let's empower ourselves with knowledge, invest wisely, and drive advancements in healthcare together. #hsa #investing #healthcare #health #family #wellness 💪💰🏥🌿❤️
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Clinical research is so important in providing patients greater access to medicines that can save lives. I'm proud to share Icon Group's Annual Research Report, showcasing the remarkable achievements of our clinical trial teams Slade Health. In 2023, Slade Health provided support to over 320 clinical trials, compounded 7,420 clinical trial products for over 1,000 trial patients. Our state-of-the-art compounding capabilities at our five TGA and Medsafe licensed facilities across Australia and New Zealand have been integral in supporting our hospital partners' efforts to advance healthcare outcomes. Learn more about our impact in the full report below. Click to read the full report: https://lnkd.in/gthXswq9 #research #cancerresearch #compounding #clinicaltrials
Annual Research Reports | Icon Group
https://icongroup.global
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☀ As we come to the end of another sweltering week here in London, it's time to look back at the hottest news in Medtech ✅ Guardant Health received FDA approval for its Shield™ blood test, paving the way for a new era of colorectal cancer screening https://t.ly/XWwqC 📈 Boston Scientific saw YoY sales of cardiovascular devices increase 20%, powered by 125% growth in revenues of its electrophysiology devices for atrial fibrilation https://t.ly/3zx6i ⏳ GE HealthCare became the most recent tier 1 medtech company to discuss delays in the China market, following a slower than anticipated rollout of a central government financial stimulus program, in its earnings report. This follows Johnson & Johnson and Philips citing the issue https://t.ly/r8j1K 📰 The FDA have started the recruitment process as they look for a new director of the CDRH, following news that Jeff Shuren will be retiring https://t.ly/tfKcu
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The European Parliament is expected to vote on the proposed transitional rules applying to the legislations on medical devices and in vitro medical devices (IVDs) via the urgent procedure. The proposal, which was assigned to the ENVI committee and is expected to be voted in the April plenary, includes: ◾️Extension of the transitional periods for certain IVDs to reduce shortages ◾️Shorter transitional period for high-risk IVDs until 31 December 2027 ◾️Longer periods for medium-risk (e.g. cancer tests) and lower-risk IVDs until 2028/2029 ◾️Individual modules of European database on medical devices (Eudamed) once operational https://bit.ly/49rqX6o #IVDR #MedicalDevices #invitrodiagnostics
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