Artiness Receives FDA Clearance for ARTICOR Platform

🎉 Congratulations to New Stetic! 🎉 We're thrilled to celebrate New Stetic S.A for receiving FDA 510(k) clearance for the Zafira Light‑Curing Device, an innovative solution designed to support precision, safety, and efficiency in aesthetic and dental procedures. The Zafira Light‑Curing device reflects New Stetic's commitment to advancing light‑curing technology with user‑focused design and reliable performance, supporting clinicians in delivering consistent, high‑quality patient care. At NAMSA, we're proud to have supported New Stetic with our biosafety and biocompatibility services, helping ensure to meet rigorous safety and performance requirements on its path to FDA clearance. "We thank NAMSA for its valuable collaboration in the biocompatibility testing process that enabled New Stetic S.A. to obtain 510(k) clearance for Zafira restorative resin. Their guidance in defining the required tests, their support throughout the testing process, and their interpretation of the results were key to this important achievement, which will allow us to bring this product to the U.S. market. Thank you for being a key partner in this milestone." Henry Alberto Rodríguez, Director of Research and Technological Management; Research and Development Manager at New Stetic If you are interested in learning more about NAMSA's biosafety services that support successful outcomes, please contact us today: https://lnkd.in/gZezerjZ Want to know more about New Stetic? Check it out: https://lnkd.in/g-pW-rDk

LifeScan has appointed Jonathan Salkin as its new CEO, marking a leadership transition for the Malvern-based medical device company following its emergence from bankruptcy at the end of 2025. Click here to read 👉 https://ebx.sh/Fyc5Qz

Wound care providers are leaving serious reimbursement behind. In some states, bacterial fluorescent imaging reimburses over $150 per encounter. Seeing just 5 wound patients twice weekly could mean nearly $75K annually in additional revenue. 💰 Same workflow. Better documentation. Additional reimbursement. ✔️ Worth a conversation… #swift #SaaS #Woundcare

One of the biggest misconceptions in wound care is that advanced imaging has to mean large capital equipment and workflow disruption. What stands out to me about Swift Ray is that it fits in the palm of your hand, clips directly onto a smartphone, and brings fluorescence + thermal imaging into everyday wound workflows without slowing providers down. The reimbursement pathway is important, but so is giving clinicians objective imaging they can actually use consistently at the point of care.

Fluorescent imaging has a reimbursement pathway - and it's been available since 2020. CMS established 2 codes to cover fluorescence imaging used during wound care encounters. At current Medicare rates, each application generates meaningful per-visit reimbursement, in addition to standard wound care codes. Swift Ray® is FDA 510(k)-cleared and generates the objective, image-based documentation required to support these claims. It's not a research device or a pilot program — it's a cleared tool with a defined billing pathway. The practices capturing this reimbursement consistently have two things in common: a cleared device and a repeatable workflow. The first wound imaging device that is truly portable - fits in the palm of your hand - seamlessly integrates with the most advanced and proven AI-driven platform available. Objective imaging, protecting from wastage, improved audit defense posture and proven reimbursement. Want to talk? #WoundCare #FluorescenceImaging #WoundCareReimbursement #SwiftRay

Theragen's patent portfolio continues to expand! The ActaStim-S spinal bone growth stimulator is the first therapeutic, recovery monitoring, and decision support platform. Patients and our HCP partners can rely on our therapeutic technology and our commitment to service! #actastim #bonegrowthstimulator #bonegrowththerapy #actastimcompanionapp #lumbarfusion #spinesurgery #spinefusion

New Post: TruLeaf Medical, a fully-owned subsidiary of Allmed Solutions successfully Completed the Second Stage of valve implantation in two Additional Patients https://lnkd.in/gxzj3BF4 #truleafmedical

Yesterday, attorney Andriy Lytvyn presented at the 19th annual Florida Medical Device Symposium, hosted by the Florida Medical Manufacturers Consortium. Andriy shared insights on integrating intellectual property strategy into medical device development and commercialization, including how innovators can protect and maximize the value of their ideas from concept through market launch. #FMMC #MedicalDevice #IntellectualProperty

enVVeno Medical Reports First Quarter 2026 Financial Results and Provides Business Update Highlighting Strategic Advancement of the enVVe System https://bit.ly/4wf9tXp #VenousDisease #CVD #CVI #VenousCare