Lighthouse Labs RVA’s Post

Liquet Medical Inc. received FDA 510(k) clearance for its Versus Catheter. The #medicaldevice is set to enhance the treatment of pulmonary artery blood clots by offering real-time pulmonary artery pressure measurements, empowering clinicians to optimise treatment based on individual patient responses. 💬 CEO John Schindler shared: “We believe this innovation has the potential to significantly improve patient outcomes, minimize risks, and reduce healthcare costs." 🔗 Read more: https://lnkd.in/djP-WP9d 📰 Follow Guided Solutions to receive the latest #MedTech news daily and subscribe to our weekly newsletter: https://lnkd.in/dQR3A73z #MedicalDevices #MedicalEquipment #HealthTech #Headhunter #TalentManagement #Leadership #LeadershipDevelopment #GuidedSolutions #ExecutiveSearch #Executive #Csuite #MedTechExecutiveSearch

Follow Market Access Today for more up-to-update healthcare news!

🚀 Merit Medical Secures FDA Approval for WRAPSODY Endoprosthesis! 🏥 A groundbreaking advancement in dialysis care has arrived! Merit Medical has received FDA approval for its innovative WRAPSODY Cell-Impermeable Endoprosthesis, designed to enhance the lives of dialysis patients across the nation. Key Highlights: ✨ Reduced Invasive Procedures: WRAPSODY may decrease the frequency of invasive interventions for dialysis access maintenance. ✨ Enhanced Patient Outcomes: Improved vessel patency could lead to higher survival rates and a better quality of life. ✨ Clinical Success: With impressive primary patency rates of 89.8% and 82.0% in clinical trials, WRAPSODY is set to become a preferred choice among healthcare professionals. Merit Medical plans to launch this revolutionary device in 2025, marking a significant step forward in maintaining critical blood flow during hemodialysis. 🔗 Click the link for more details on this exciting development! #Dialysis #FDA #FDAApproval #HealthcareInnovation #HealthcarePolicyandRegulation #MedTech #MedicalTechnology #MedtechCompanies #PatientCare #RegulatoryAgencies #MarketAccess #MarketAccessToday

Centerline Biomedical has announced that it has received the US Food and Drug Administration (FDA) 510(k) approval for its new Intra-Operative Positioning System (IOPS) guidewire handle. Vikash Goel https://lnkd.in/eDP28tfu

Vyaire Medical Recalls AirLife Manual Resuscitators in Class I FDA Alert Over Critical Manufacturing Defect Vyaire Medical has recalled several models of its AirLife manual resuscitators due to a manufacturing flaw that can cause serious harm or death. The recall affects a wide range of models distributed across the United States and is classified as Class I by the FDA. The defect can result in inadequate ventilation for patients, leading to conditions such as hypoxia or hypoventilation. There have been 37 reported incidents, including two deaths and injuries. The recall covers an estimated 6.6 million devices with specific product codes and manufacturing dates before 2017. Healthcare providers are urged to remove affected devices from their inventory. Vyaire has advised disposing of the defective resuscitators. For more details please click the link! https://lnkd.in/dsKCw98p #marketaccess #reimbursement #pricing #hta #heor #healtheconomics #medicaldevices #pharmaceutical

Struggling with precise and safe radiopharmaceutical dosing while dealing with limited space and strict regulations? Improving your processes help to cut costs, enhance dosing accuracy, and significantly boost patient safety. This is where traditional manual methods are often inefficient and prone to errors. Join us at EANM in Hamburg to see how our solution, the OVD-system, tackles your challenges head-on. Want to learn more about how and why we developed the OVD system? Follow the link to our Blog and understand our way from concept to a product that solves global challenges. https://ow.ly/Ribz50TNibA #ctsgroup #innovation #radiopharmacy #eanm2024

https://lnkd.in/gZgS2MSY #BIGNEWS Following recent FDA clearance of the INSPIRA ART100 via 510(k) medical device regulatory pathway as Westchester Medical Center Health Network in collaboration with Inspira Technologies ( Nasdaq : IINN) plans to introduce the INSPIRA ART100 at their flagship hospital Westchester Medical Center to evaluate the performance and effectiveness of the device in various real world scenarios. Learn more from today's news linked below or visit the video link to see more about the company and other novel devices in their pipeline working towards future regulatory submission. This post is for informational purposes and in no way represents a solicitation for investment. Poster is engaged in a compensated marketing effort. Clearance of a medical device via a 510(k) regulatory pathway with the FDA does not represent an endorsement of any kind. https://lnkd.in/d7YVhnds #medicaldevice #biotech #stocks #technology #innovation

👍 enVVeno Medical announced positive data from a trial examining its VenoValve, a first-in-class surgical replacement venous valve, demonstrating that 94% of patients using the valve showed clinical improvement. CEO Robert Berman said: "We are hopeful and determined to bring relief with the VenoValve to the millions of patients suffering from severe deep venous CVI, who have no effective treatment options.” 👏 🔎 Full story: https://lnkd.in/eFZWFpTr 📰 Follow Guided Solutions to receive the latest #MedTech news daily and subscribe to our weekly newsletter: https://lnkd.in/eCCzKfHT #MedicalDevices #MedicalDevice #MedicalEquipment #Medicine #Surgeons #MedTech #GuidedSolutions

Infusion Pump Market worth $26.2 billion by 2029 Download PDF Brochure:-https://lnkd.in/dEY9Nd7F The infusion pump market size is projected to reach USD 26.2 billion by 2029 from USD 17.1 billion in 2023, at a CAGR of 7.3% during the forecast period. 𝐓𝐡𝐞 𝐜𝐨𝐦𝐩𝐚𝐧𝐢𝐞𝐬 𝐟𝐞𝐚𝐭𝐮𝐫𝐞𝐝 𝐢𝐧 𝐭𝐡𝐢𝐬 𝐫𝐞𝐩𝐨𝐫𝐭 𝐢𝐧𝐜𝐥𝐮𝐝𝐞 Becton, Dickinson and Company (US), Baxter International, Inc. (US), and B. Braun Melsungen AG (Germany). 𝐎𝐭𝐡𝐞𝐫 𝐜𝐨𝐦𝐩𝐚𝐧𝐢𝐞𝐬 𝐭𝐡𝐚𝐭 𝐚𝐫𝐞 𝐨𝐩𝐞𝐫𝐚𝐭𝐢𝐧𝐠 𝐢𝐧 𝐭𝐡𝐢𝐬 𝐦𝐚𝐫𝐤𝐞𝐭 𝐠𝐥𝐨𝐛𝐚𝐥𝐥𝐲 ICU Medical, Medtronic Smiths Medical Fresenius Kabi Terumo Medical Corporation Nipro Medical Corporation Micrel Medical Devices Insulet Corporation Abbott Roche Diagnostics UK & Ireland KARL STORZ CME Corp. Avanos Medical, OMRON Healthcare, Inc. Ambu A/S CODAN Medizinische Geräte GmbH Flowonix Medical, Advanced Infusion Solutions (AIS) Q Core Medical Ltd. Alaris Medical Systems ZEUS Scientific, PharMEDium Services, Tandem Diabetes Care, Epic Medical Baxter International Inc. ICU Medical, Ivenix Infusion System #infusionpump #medicaldevices #healthcaretechnology #patientsafety #medtech

ExoStat Medical Receives FDA Clearance For Novel, Real-Time, Oral Tissue Perfusion Sensor System ExoStat Medical, Inc. announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance to market its MicroTREND System, the culmination of decades of research and development. It is the world’s first and only real-time, bedside, non-invasive disposable sensor system approved for identifying and monitoring microcirculatory tissue hypoperfusion resulting from low blood flow. The MicroTREND was designed to directly detect and monitor tissue hypoperfusion at the microcirculatory hemodynamic level as it manifests into a dangerous medical emergency. The MicroTREND incorporates an electro-conductance platform with a disposable sensor that is seated non-invasively in the oral mucosal tissue of a patient, a convenient and accessible site from which to measure pCO2. Jim Hays, CEO of ExoStat Medical, Inc., stated that “the 510(k) clearance of the MicroTREND marks an important commercial milestone for ExoStat, and we look forward to working with key strategic partners to advance the next steps of the journey to improve patient care.” For more information, see the below press release. https://lnkd.in/gW6_F3Ex