Jennie Crabbe’s Post

US MEDICAL DEVICE MANUFACTURING WEEKLY ROUND-UP 💉 💊 Alcon completed the takeover of BELKIN Vision. the $81M deal will allow selective laser trabeculoplasty, an alternative treatment for ocular hypertension and glaucoma, to be manufactured and sold in the US! 🏥 Merit Medical Systems, Inc. acquired Esophyx Z+, a minimally invasive device used to treat gastroesophageal reflux disease, from EndoGastric Solutions worth $105M. The device is expected to add $30M to its annual sales and more importantly, treat the 20% of the US population who suffer from GERD. 👨⚕️ FDA has partnered with Bill & Melinda Gates Foundation in the hope of improving disease detection. The $1.9M collaboration will create new analytical methods to help the development of breath-based diagnostic devices! #Manufacturing #Medical #Medicaldevices #USmedicaldevices #USmedicaldevicemanufacturing #Medicaldevicemanufactruing

What's happening in ophthalmic clinical trials? Check out what Julie Schlosser has to say about it. And be sure to connect with our experts if you're going to either SECO or ASCRS! _____________________ #ophthalmology #clinicaltrials #lifesciences

Anuncia Medical announced the first successful U.S. implantation of its FDA-cleared ReFlow™ System with the Sonolucent Cranial Plate, performed at Johns Hopkins. These innovative devices enable noninvasive visualization of hydrocephalus shunt flushing and were used in tandem to treat pseudotumor cerebri, marking a significant advancement in patient care. Read more about it here: https://bit.ly/41hYj7i

If you are in Seattle for the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting #ARVO2024, visit Booth 1524 and try our Clinical Trial Suite for yourself. For over three decades, our suite has been at the forefront, delivering customizable, FDA-recognized, and peer-reviewed testing solutions—ranging from Automated ETDRS to innovative Contrast Sensitivity systems. This technology not only enhances precision and efficiency across global clinical trials but also sets new benchmarks in scientific accuracy and user-friendliness in the eye care industry. https://lnkd.in/eVnF4ZKw M&S Technologies, A Hilco Vision Company #visionresearch #ophthalmology #ocularresearch #clinicalopthalmology #ocularscience #visualfunction

🔬 Breaking: FDA Approves Boston Scientific's Revolutionary Cardiac Device TL;DR: Boston Scientific secures FDA approval for their navigation-equipped pulsed field ablation catheter, advancing atrial fibrillation treatment. 🔍 Key Development: This grounddevice offers a minimally invasive approach to treating atrial fibrillation, combining precision navigation with innovative ablation technology. 💡 Industry Impact: - Sets new standards in cardiac care - Validates market demand for minimally invasive solutions - Demonstrates successful regulatory navigation in advanced medical tech 📋 Strategic Takeaways for Biotech Leaders: 1. Prioritize R&D in precision-driven treatments 2. Explore partnerships in electrophysiology tech 3. Strengthen regulatory compliance strategies What's your take on this advancement in cardiac care? Are you seeing similar innovations in your area of focus? Share your thoughts below. #BiotechInnovation #MedicalDevice #FDA #Healthcare #CardiacCare

🔝 The #regulatoryworkshop delivered by ASPHALION expert Joan Cabellos offered an overview of the #EU's legal framework for #MedicalDevices (#MD) and #InVitroDiagnostic Devices (#IVDs), emphasizing early #regulatoryawareness to ease market entry. It covered #regulatory classification rules, definitions, and #EUrequirements, focusing on demonstrating #quality, #safety, and #efficacy for #CEmarking. ▶ Participants engaged in applying these concepts to the FLAMIN-GO Project product, highlighting the need for alignment with #EUstandards. The workshop also discussed #performanceevaluation for IVD #regulatorycompliance, underscoring the importance of proactive #regulatorystrategies in commercializing innovative #biomedical #technologies. 😊 Thank you, Giuseppe Cappellano. #OoC #OrganonChip #RA #RegulatoryAffairs #RegulatoryRoadmap #WeAreAsphalion #WeCare #MeetTheExpert #KnowledgeFromExperience

Madison-based RadUnity has received FDA clearance for its time-saving #medicalimaging product, clearing the way for commercial distribution. The #startup company recently announced the federal agency approved its 510(k) Class II Medical Device application, which founder Timothy Szczykutowicz says will help secure additional 💰funding and expand the team. He launched the company in 2023 based on research patented through the Wisconsin Alumni Research Foundation (WARF), and holds a position as associate professor of #radiology at University of Wisconsin-Madison. “With this clearance, we’ve made a significant leap toward turning an 🎓 #academic concept into a practical 💡 #clinical solution … It brings us closer to fulfilling my goal of providing a solution that the community will embrace and use to improve patient care,” Szczykutowicz said in a statement. Read more ⏩ https://lnkd.in/gN6fNCr8

Today, we had an excellent workshop on the regulatory aspects of Organ-on-a-Chip (OoC), delivered by Joan Cabellos from ASPHALION. Joan provided valuable insights into the regulatory classification of medical devices and in vitro diagnostic medical devices, offering practical knowledge that will be instrumental for the future of FLAMIN-GO Project. This session emphasized the importance of understanding regulatory frameworks to successfully navigate the path to market for innovative technologies like OoC. Associazione per la Ricerca che CurA (ARCA) #workshop #regulatoryaspects #organoonchip #rheumatoidarthritis

The WHO has published a global medical device database, MeDevIS, which currently contains information on more than 2,300 devices ranging from neonatal care to cancer treatment. This platform aims to address the lack of a centralized repository for the over 10,000 types of medical devices available worldwide, providing stakeholders with valuable information for decision-making. By incorporating both the European Medical Device Nomenclature (EMDN) and the Global Medical Device Nomenclature (GMDN) naming conventions, MeDevIS has the potential to significantly advance the international medical device market. How do you see this being used? #globalhealth #medtech #RAPS

A review summarising the scientific principles, indications, outcomes, and current limitations of pupillometry used for evaluation of afferent pathways in ophthalmic clinical settings. Read in full here: https://lnkd.in/ea9Pe3Nk #Ophthalmology #Neuo