NAMSA

🚀 Hear expert insights from Dawn Bitz, President at Lazzaro Medical, on when startups should begin their economic and reimbursement strategy. Whether you're launching a new MedTech company or scaling your innovation, understanding the right timing for your reimbursement strategy is crucial for success. https://lnkd.in/gnFZpY7G #MedTech #Startups #Reimbursement #HealthcareInnovation #NAMSA

In 2025, ASCA-accredited biocompatibility submissions had a deficiency rate of just 5.1% — down from ~37% during the pilot phase. Here's what's driving it: → ASCA testing is pre-vetted by FDA against consensus standards → In eSTAR, ASCA submissions collapse pages of required fields to 3 actions per endpoint → Fewer Additional Information (AI) requests, faster prep, stronger regulatory record NAMSA was the first U.S. lab to earn ASCA accreditation in 2021 and remains the only one accredited for the full panel of eligible test methods. Only 5 biocompatibility labs worldwide hold active ASCA accreditation today. If biocompatibility is on your 510(k) critical path, this one's worth reading. 🔗 https://lnkd.in/gSWcvqbS #MedicalDevices #510k #Biocompatibility #ASCA #RegulatoryAffairs #eSTAR #NAMSA

Last chance to register for the live event tomorrow! Struggling with gray zones in the revised ISO 10993‑1? NAMSA's upcoming webinar explores practical ways to tackle biological risk estimation, repeated use, and foreseeable misuse. 💡 Key topics: ~ Rethinking "long-term" exposure with non-exposure periods ~ Estimating risk when precise data is missing ~ Managing foreseeable misuse without overcomplicating Join us for real-world scenarios, audience polling, and actionable insights. 📅 Save your spot today! https://lnkd.in/g7k95CQF #MedicalDevices #ISO10993 #Webinar

Pulsed field ablation (PFA) is reshaping cardiac rhythm treatment — but the path from concept to FDA-approved device is more demanding than the technology alone. For sponsors developing novel PFA systems, success hinges on early FDA alignment, rigorous preclinical evidence, and a clinical strategy built for PMA review. The Medtronic PulseSelect™ approval set the precedent. The question is: what does that roadmap look like for your program? We break it down — from Pre-Sub engagement through post-market surveillance — in this article. https://lnkd.in/gCZ4SryK #PulsedFieldAblation #CardiacAblation #MedicalDevice #FDAApproval #RegulatoryStrategy #Preclinical #Atrial Fibrillation #MedTech

🎉 Congratulations to Artiness! 🎉 We're thrilled to celebrate Artiness for receiving FDA 510(k) clearance for ARTICOR™, an advanced mixed‑reality planning platform designed to support structural heart and vascular procedures. ARTICOR™ enables clinicians to create patient‑specific 3D reconstructions, supporting detailed anatomical analysis, device sizing, positioning, and procedural planning. By combining desktop software with an augmented‑reality environment, ARTICOR™ helps physicians visualize complex anatomy, optimize treatment strategies, and prepare fluoroscopy angles prior to intervention—enhancing precision and confidence in challenging procedures. Achieving FDA clearance represents a major milestone for Artiness and validates their innovative approach to integrating extended reality (XR) into pre‑operative planning for structural heart and vascular care. At NAMSA, we're proud to have supported Artiness with 510(k) submission services, working closely with their team to develop a strong regulatory strategy and guide ARTICOR™ through the FDA clearance process. "At ARTINESS, we have been pleased by the senior and professional advisory of NAMSA, making the process controlled and smooth and ensuring that our ARTICOR platform could reach such an incredible achievement.", Filippo Piatti CEO & Co-Founder If you are interested in learning more about NAMSA's 510(K) submission services that support successful outcomes, please contact us today: https://lnkd.in/gzh_twxc Want to know more about Artiness? Check it out: https://lnkd.in/dNmk8tX

Tight timelines? Complex testing? NAMSA's chemical characterization experts deliver actionable insights with speed and precision—helping you meet deadlines and regulatory expectations. 🔗 Learn more: https://lnkd.in/g85C94S5 #ChemicalCharacterization #Biocompatibility #ISO10993 #NAMSA #MedTechTesting

🌟 Join NAMSA for Expert Biocompatibility Training! 🌟 Looking to navigate the latest updates in ISO 10993 standards and MDR requirements? Don't miss our Biological Safety Training Event in Suzhou, China! This two-day certification course offers hands-on learning, real-world exercises, and expert insights to help you tackle regulatory challenges. Delivered in English with live Chinese translation, it's the perfect opportunity to sharpen your skills and gain certification as a Biological Safety Specialist. 🔗 Register Now: https://lnkd.in/guAEPU_9 #MedicalDevices #BiologicalSafety #NAMSA

🌍 Entering the U.S. market is one of the biggest opportunities — and challenges — in MedTech. We're thrilled that NAMSA's Chief Medical Officer, Adam E. Saltman, MD, PhD, will be speaking at an exclusive seminar hosted by Snitem on June 15 (10:45 AM – 2:00 PM), organized by MALIC (Marie Lannelongue Innovation Center). In just one afternoon, you'll gain: 🔬 Regulatory insight — FDA requirements, submission strategies, and compliance planning through 2026. 📈 Commercial know-how — Build a winning U.S. distribution strategy and avoid the classic launch pitfalls. 👉 Register by contacting catherine.martin@snitem.fr #MedTech #FDA #USMarketEntry #Regulatory #NAMSA #MedicalDevice #MarketAccess #SNITEM

Struggling with gray zones in the revised ISO 10993‑1? NAMSA's upcoming webinar explores practical ways to tackle biological risk estimation, repeated use, and foreseeable misuse. 💡 Key topics: ~ Rethinking "long-term" exposure with non-exposure periods ~ Estimating risk when precise data is missing ~ Managing foreseeable misuse without overcomplicating Join us for real-world scenarios, audience polling, and actionable insights. 📅 Save your spot today! https://lnkd.in/g7k95CQF #MedicalDevices #ISO10993 #Webinar

When a medical device enters the body, sterility assurance is just the beginning. The real risk? What happens when microorganisms meet your device after it's in use — during handling, implantation, or indwelling. In this blog, we break down what microbial animal model testing actually evaluates, which devices benefit most, and what actionable evidence manufacturers can walk away with. If your device is intended to reduce infection risk or support an antimicrobial claim, this one's worth a read. https://lnkd.in/g--x2J_y #MedicalDevices #InfectionPrevention #MedTech #Microbiology #NAMSA