Holly Scott

Lumicell was granted FDA approval for the first NDA & PMA in the last 10 years this past April. With 84% accuracy, this phenomenal combination product identifies residual cancer tissue in real time that could have been missed during surgery. Historically, 1 in 8 women developed breast cancer and due to the challenges of eliminating the entire tumor, up to 36% of women need a second surgery. This incredible technology can help create greater patient outcomes and increase healthcare efficiency by reducing the need for second surgeries. Most of us know or have known someone who has been affected by cancer and to understand that a loved one has gotten through surgery successfully without any residual cancer cells would provide an incredible peace of mind. https://lnkd.in/ekaNs8ny #innovation #breastcancer #oncology #medtech #FDAapproval #cuttingedgetechnology

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Sunday Funday! Let's review the best #medtech news of the week, shall we? AtaCor Medical, Inc. raised on $28 Mil towards their cardiovascular pacing technology Rick Sanghera #neuromodulation company addressing chronic conditions iVEAcare, Inc. announced a $27 Mil raise Todd Kerkow Annoviant, a startup focusing on products that heal and grow with #CHD patients, received a 3 Mil$ grant for their #pediatric pulmonary valved conduit Ajay H. Bill Colone and team at Single Pass announced #FDA clearance for their Kronos Cautery biopsy closure device Roivios, Ltd. a company pioneering treatment for #renal insufficiency announced #FDA breakthrough device designation status John Erbey Hyalex Orthopaedics Inc. announced #FIH first in human clinical trials for their synthetic knee cartilage implant Carl Vause Healthplus.ai received CE certification for its #SaMD platform that allows hospitals to predict infections after operations Bart Geerts Lumicell received #FDA approval for its visualization system for #cancer removal Howard Hechler Science Corporation, a #BCI technology company, acquired #IP from Pixium Vision S.A. to integrate their retinal implant technology into their products addressing blindness. The CEO is formerly of Neuralink Max Hodak #FDA wants to advance #HealthEquity through initiative “Home as a Health Care Hub,” addressing long standing disparities in healthcare access and outcomes Provisio Medical received #FDA clearance for its sonic lumen technology, a version of #IVUS George Quinoy Lastly, the most buzzed about news this week was the announcement by Federal Trade Commission to ban noncompetes. This decision will "promote competition, protect the fundamental freedom of employees to change jobs, increase innovation and foster new business formation". Especially in #medtech where patients benefit with increased innovation, this is good news. Big thanks to LSI, MassDevice, MedTech Innovator, MedTech Dive and the many friends throughout the industry that share good news with me regularly. #medtechnews The Mullings Group #startups #patientsfirst #medicaldevices #funding #innovation #healthtech #biotech https://lnkd.in/ezwe5PGv

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"Despite the explosion in demand for weight loss drugs known as GLP-1s, 58% of patients discontinue use before reaching a clinically meaningful health benefit." This high of a discontinuation rate is entirely avoidable with the right coaching and follow-up. If you are prescribing GLP-1s and not using the Virtual Care Suite (VCS) to increase engagement, monitor patient progress, and improve long-term outcomes, you are missing out. Send Brian Conyer a DM to get started on the VCS. I believe it will change your entire practice. https://lnkd.in/eS66Gu6v

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Thanks for sharing, Tonya. How will this impact MedTech? Previous enforcement of non-competes has always been state-specific. It will be interesting to understand how employment agreements are created going forward, and how they are affected now. https://lnkd.in/gaBq4t4i

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Key takeaway from MedTech MVP's "Breakthrough Device Panel Discussion": "While patient impact is advanced by improved times for novel devices (via the De Novo or PMA) there remains opportunity. The 510(k) is the most common application type and the "workhorse" for medtech innovation. Here we can stand to get more innovative solutions." #medtechmvp #breakthroughdevices #510kpathway #denovo #thoughtleadership #conferencerecap

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For too long, non-compete clauses (NCCs) have been a burden on employees, barring them from working and limiting their career growth. Finally, the FTC is taking action with a new NCC ban. This article shares the reluctance of hospitals to embrace the new ruling. If you've ever been affected by NCCs (especially in the medical space); had to wait years for a NCC to expire to work in your field, been dismissed from interviews, or received legal "notices," you'll want to read this and celebrate this ruling with me. #FTC #NCCBan #EmployeeRights

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The battle over Sepsis-2 vs. Sepsis-3 continues. Advocates of Sepsis-3 state that it offers a more clinically accurate and rigorous definition, and sepsis-2 too vague to be truly useful. Advocates of Sepsis-2 believe that is more sensitive and superior for early detection, and sepsis-3 too high a bar to capture the wide spectrum of the condition. Could both be true? I think so. The real problem may be that we aren’t adequately reimbursing hospitals for aggressive early interventions. Today both definitions remain in play, and auditors are using various criteria (including SOFA) to deny claims, adding further chaos to the landscape. View the clip below featuring Trey La Charite'​, MD, FACP, SFHM, CCS, CCDS weighing on the issue (his organization remains a steadfast advocate of sepsis-2). If you haven’t yet listened to the full episode featuring 50 minutes with Trey what are you waiting for? He rocks, and shares his opinions freely in the episode. *** This issue isn’t going away any time soon, especially with the OIG adding sepsis claims to its Work Plan last month (see below). I wanted to dig further into the realities and so the next episode of Off the Record features a guest working on the front lines of sepsis care, as a clinician. It was a great conversation and I can’t wait to bring you the episode Wednesday.

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Does a perfect world exist??? RD rapid prototypes every week. Regulatory loves RD. Die Mold shop fist 👊 bumps RD. Contract Manufacturing loves when medical device engineers are on production floor. Sterilization house calls you back in 5 mins. It does! VitaTek RD/Rapid Prototyping/Weekly in house Hydrophilic Coating in house Regulatory in house Die Mold Tooling in house Contract Manufacturing in house Sterilization in house www.vitatek.io Medical Device Development Manufacturing Everything In House #prototyping #rapidprototyping #contractmanufacturing #manufacturing #medical #medicaldevices #sterilization #medicaldevicemanufacturing #researchanddevelopment #researchdevelopment #equity #privateequity #capital #hydrophilic #coatings #diemolds #meddevice #doctors

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#DeepLearning is bringing clarity to the next generation of #SPECT #medicalimaging. At #SNMMI24 #GEHealthCare was proud to introduce its new Clarify DL* image reconstruction solution, designed to reduce noise while maintaining contrast. Included in a new package of capabilities with #StarGuide, Clarify DL is designed to improve image quality, which may help increase diagnostic confidence for improved patient outcomes. To learn more, watch our new Clarify DL video: https://lnkd.in/gF83jd9j *Clarify DL is 510k-pending with the U.S. FDA. Not available for sale in the United States or Canada. Not licensed in accordance with Canadian law. Demonstration purposes only – not for human use. #nuclearmedicine #spect #molecularimaging #healthcare #personalizedcare

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Are you ready to transform your business strategies and maximize your product's potential? Dive into this essential read on value analysis!

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“It’s like having a business coach who's lovingly punching holes in your argument to give you the best shot!"—Tim Martin, Generative AI Training Expert, on the power of AI for decision-making. This latest episode of Innov8 Your Career in Med Tech & Life Sciences by Innov8Search explores the new world of generative AI and its potential to revolutionise business decision-making. Are you curious about how generative AI can empower your med tech, biotech or pharma business? Tune in to the full episode and learn how to: Stop costly mistakes: Stress-test ideas with AI before you invest. Win negotiations: Develop killer arguments with AI by your side. Future-proof your business: Make data-driven decisions with AI. Listen now (link to episode in comments) and share your insights below. ✨ #GenerativeAI #AIforBusiness #BusinessDecisionMaking #MedTech #biotech #pharma

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Did you know? Tracking your fertility can help in identifying underlying health issues. Learn more fascinating facts with KNOWHEN®. #FertilityFacts #HealthEducation

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Surgery Wait Times Got You Stressed? There's an AI Solution! PT Medical Technologies spotlights a new innovation in healthcare: Here's the scoop: AI optimizes hospital OR scheduling: Reduces wait times and boosts efficiency. Maximizes resource allocation: Saves hospitals money and generates new revenue. Solves staffing shortage struggles: Empowers healthcare professionals in a challenging time. PT Medical Technologies is excited about the future of AI in healthcare! Learn more by @‌med-technews here: https://lnkd.in/guna38Sy Source: med-technews PT Medical Technologies, INC - One Source for All Medical Equipment, Buy, Sell, and Trade with us. #HealthcareAI #OpmedAI #MedicalInnovation

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The Federal Trade Commission has banned noncompetes nationwide. In the landscape of career development in which future opportunity is determined in large by experience, this is an important development. “Noncompete clauses keep wages low, suppress new ideas, and rob the American economy of dynamism, including from the more than 8,500 new startups that would be created a year once noncompetes are banned,” said FTC Chair Lina M. Khan. “The FTC’s final rule to ban noncompetes will ensure Americans have the freedom to pursue a new job, start a new business, or bring a new idea to market.” "The FTC estimates that the final rule banning noncompetes will lead to new business formation growing by 2.7% per year, resulting in more than 8,500 additional new businesses created each year." https://lnkd.in/ezwe5PGv

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🚀 Privileged to serve the medtech industry through my role at Integer! 👩‍⚕️🔬 The insights shared by Edward Arguello on neurovascular device development are spot-on. Addressing challenges early and partnering with experts can make all the difference. Check out the article: “Addressing the Challenges of Neurovascular Device Development—A Medtech Makers Q&A.” 💡👇 https://lnkd.in/gSfxE7Ya

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🔗Standardizing Vendor Credentialing for Medical Device Sales Reps: Enhancing Healthcare Compliance In the healthcare sector, the pivotal role of medical device sales reps can't be overstated—they bridge the gap between manufacturers and healthcare providers, ensuring the effective use of medical technologies. However, the lack of standardized vendor credentialing has posed challenges, affecting patient safety and regulatory compliance. This insightful article sheds light on the critical need for standardized credentialing processes, emphasizing how they can enhance healthcare compliance, streamline operations, and ensure the highest quality of care. 🌟 Key highlights include: - The importance of vetting sales reps to maintain patient safety and compliance. - The challenges of the current fragmented credentialing practices. - The substantial benefits of standardizing these processes, such as improved compliance, reduced administrative burdens, and consistent quality of care across facilities. - Essential components of effective vendor credentialing, including uniform criteria, centralized platforms, and regular monitoring. 👏 Special thanks to Jason Gwilliam of JDG. for sharing his extensive expertise on this vital topic. With 18 years of leadership experience in medical device sales and sales enablement, his insights are invaluable. https://lnkd.in/gDQZjq6S

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I think we can all agree that without device reps in theatre patient outcomes would suffer, especially for new devices, next generation software & hardware. How is a surgeon expected to keep up with medical technology without a rep in theatre to educate them? As products become more advanced with AI enablement the device reps job will become even more important. #medtech #medicaltechnology #medicaldevices #prosthesislistreform

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🔬💬 Let's Hear Your Voice! The FTC's proposed final non-compete rule is generating buzz in MedTech. Share your thoughts from different perspectives. Your insights shape the conversation. #MedTechTalks #DiverseViews Join the discussion here: [FTC Fact Sheet on Proposed Final Non-Compete Rule](https://lnkd.in/g8NGhBkR)

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If you are in the #medicalimaging #radiology space and aren't tuning in to Brian's The Imaging Wire show, then you are missing out on the good stuff! Such a well-balanced take on so many different topics!

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