CMR Surgical’s Post

As 2024 draws to a close, we're taking the time to look back at the moments and memories that shaped our year. In October, we were excited to announce that CMR Surgical was granted U.S. FDA Marketing Authorization for the use of #Versius in Cholecystectomy. The FDA marketing authorization of #Versius is a significant milestone, with Versius being the first multi-port, soft tissue general surgical Robotic Assisted Surgical Device (RASD) to successfully be authorized through FDA’s De Novo application process. Versius is a RASD intended to assist in the precise and accurate control of Versius Surgical endoscopic instruments and is indicated in the U.S. for adult patients 22 years of age and older, eligible for soft tissue minimal access surgery, for cholecystectomy. Find out more about our FDA approval: https://lnkd.in/eKWPjD4Y #CMRSurgical #TransformingSurgery

Paragon 28’s CEO, Albert DaCosta commented, “At Paragon 28, we have always been focused on matching solutions to the needs of the patient, and each patient is unique. We are adding a great new option to our suite of Bunion solutions with the launch of our PRECISION® MIS System that will help Paragon 28 and surgeons treat a broader array of patients with Hallux Valgus. I am proud of what our design surgeons and engineering team achieved in developing this system, which will bring benefits associated with minimally invasive surgery to our patients and surgeons in a reproducible way.” The Precision® MIS Bunion System is used to complete a distal metatarsal osteotomy through the use of a minimally invasive surgical technique. The system features an outrigger designed for controlled tri-planar correction including translation and derotation of the metatarsal head and adjustment of the distal metatarsal articular angle. Instrumentation is also provided to facilitate a free-hand technique. The PRECISION® MIS Bunion System includes cannulated chamfer screws for fixation that allow alignment of the metatarsal head near the cortex of the first metatarsal. This minimally invasive technique is joint preserving, and screw placement is designed to reduce the chance of soft tissue irritation. Learn more about this novel bunion solution to treat your patients with Hallux Valgus - https://lnkd.in/gHjEfRSJ #paragon28 #P28 #footandankle #FNA #improvingpatientlives #dedicatedtofootandankle #precision #precisionguided #MIS #bunion #osteotomy

Why do doctors free-hand MIS Bunions? Because poorly engineered instrumentation on early launches delivered suspect results and doctors had to pivot...not ideal! Solution: P28 Precision MIS System - the free-hand fix!

🩺 "Basil's Regulatory Roundup: Annual Insights Across Panels" presents an incisive look at the General & Plastic Surgery panel's review outcomes from the past year. The panel has evaluated and cleared 387 new 510(k) submissions, alongside 6 De Novo clearances and 2 PMA approvals, showcasing a spectrum of innovation aimed at enhancing surgical care. Furthermore, the diligent improvements to existing devices are evident from 154 PMA supplements, reflecting the commitment to progressive healthcare solutions. 🔎 Surgical precision at the forefront: Electrosurgical cutting tools and powered laser surgical instruments have dominated the clearances with 85 and 75 approvals respectively, emphasizing the technological strides in operative precision and efficiency. General laparoscopes also made a significant mark with 41 clearances, highlighting a shift towards minimally invasive techniques. With each approval, the General & Plastic Surgery panel continues to shape the contours of surgical practice, ensuring better outcomes and transforming patient experiences. Stay tuned as we dissect more data and share pivotal insights from other panels in our "Basil's Regulatory Roundup" series. #GeneralSurgery #PlasticSurgery #MedicalDevices #FDAApproval #MedTech #SurgicalInnovation #RegulatoryAffairs #fdacleared #BasilSystems #FDA

Enhancing Surgical Precision with IMAGE1 S™ Rubina® - 4K imaging and NIR/ICG Technology As we continue to embrace technological advancements in the medical field, the importance of 4K technology coupled with NIR/ICG in surgical procedures cannot be overstated. This combination is revolutionizing how surgeons perform operations, enhancing both safety and outcomes. IMAGE1 S™ Rubina® 1.     Improved Visualization - NIR/ICG technology allows surgeons to see beyond the visible spectrum, providing real-time, enhanced images of blood flow and tissue health. 2.     Reduced Risk of Complications - With better visualization, surgeons can more easily avoid critical structures and ensure proper blood flow, significantly reducing the risk of postoperative complications. 3.     Faster Recovery - Accurate targeting might lead to less tissue damage, which again can lead to quicker patient recovery and shorter hospital stays. KARL STORZ IMAGE1 S™ Rubina® is not just a tool; it's a paradigm shift in surgical care. As we integrate 4K imaging and NIR/ICG into more procedures, we are setting new standards for safety, precision, and patient care. KARL STORZ – Shaping the future of surgery! Contact us for more information or to book a demo - post-no.karlstorz.com #karlstorz #rubina #icg

Philips has announced its latest strategic alignment with BD Advanced Patient Monitoring (APM) to allow the integration of trusted FloTrac™ hemodynamic monitoring technology (formerly from Edwards Lifesciences) into Philips bedside patient monitors. This interoperability helps to streamline point-of-care decisions by offering clinicians quick access to the insights they need to help enhance the quality of patient care. Integrating BD’s minimally-invasive FloTrac ™ technology – easily placed on any existing arterial line – into Philips patient monitors offers continuous clarity and proactive decision support to help efficiently manage hemodynamic instability during surgery and post-operative care. FloTrac is compatible with Philips IntelliVue monitors MX500, MX550, MX750, MX850, PM6000 series, the integration has received CE Mark and is now available in Europe. Read more here in Dutch: https://lnkd.in/e2sSD7ZM

We are proud to highlight the successful completion of a tonsillectomy procedure using the advanced RF Plasma System. This cutting-edge technology is transforming ENT surgeries by providing: ✅ Precision – Targeted tissue removal with minimal damage to surrounding areas. ✅ Reduced Pain – Lower thermal damage leads to better post-op comfort for patients. ✅ Faster Recovery – Minimizing downtime and enhancing healing outcomes. At LithosMed, our goal is to empower healthcare professionals with tools that improve patient care and surgical outcomes. With innovations like the RF Plasma System, we’re driving the future of surgery one step closer to perfection. #HealthcareInnovation #ENTsurgery #Tonsillectomy #RFPlasmaSystem #PatientCare

The ConMed ClearGuard LE™ Endoscopic Soft Tissue Release System is a medical device designed for minimally invasive procedures, specifically in soft tissue release surgeries. Its primary use is to aid surgeons in performing precise and controlled soft tissue releases, commonly in areas such as tendons or ligaments, while minimizing damage to surrounding structures. Key Uses: 1. Minimally Invasive Soft Tissue Release: - Used for procedures like releasing tight or restricted soft tissues that can cause pain or functional limitations. - Common applications include treating conditions like carpal tunnel syndrome, plantar fasciitis, or other areas requiring tendon or ligament releases. 2. Enhanced Visualization: - The system incorporates endoscopic technology, providing real-time, clear visualization of the surgical site, allowing surgeons to work with greater accuracy. 3. Precision Cutting: - It includes specialized cutting tools and blades designed for controlled, safe incisions. This helps reduce the risk of accidental damage to surrounding tissues. 4. Improved Patient Outcomes: - The minimally invasive approach often leads to reduced postoperative pain, faster recovery times, and smaller scars compared to traditional open surgery. Why It's Beneficial: Efficiency: Streamlines the procedure by combining visualization and precise instrumentation in one system. Safety: Reduces the risk of complications by allowing for targeted tissue release. Patient Comfort: Minimally invasive techniques typically result in quicker recovery and less downtime. To know more, visit mediquinmedical.com. #OrthopedicCare #SurgicalInnovation #FastRecovery #PrecisionMedicine

🚶♀️ Exactech rolls out new balancing software for its Newton Knee System The technology enables patient-centric planning and modern alignment philosophies for total knee replacement surgery using intra-operative ligament laxity and alignment data. The new software will upgrade its unique Newton Knee balancing technique to enable simultaneous planning of the femur and tibia resections, said the medical technology company. Exactech knee and AST senior marketing director Peter Cipolletti said: “The evolution of our digital knee platform demonstrates Exactech’s dedication to providing our surgeon partners with advanced technology for ligament-driven, personalized knee surgery. “With over 3,000 cases completed to date, the Newton Knee technique has rapidly become the favored method for GPS-guided knee replacements, confirming our conviction that embracing the principles of modern alignment is essential to enhancing patient satisfaction in total knee replacement.” Exactech said that the new software is the latest offering in its high-technology knee system, to meet the needs of younger, more active patients. The system features transformative innovations, including 3D-printed Truliant cementless components and advanced Activit-E polyethylene inserts. Read more online: https://lnkd.in/ejC52niD 📰 Follow Medical Device Developments to receive the latest medical device news daily and to subscribe to our weekly newsletter #MedicalDeviceDevelopments #medicaldevices #medicalmanufacturing

Astura Medical is pleased to announce the FDA 510(k) approval for the Masada Modular MIS Spinal Fixation System!   Masada MIS is designed to empower surgeons by delivering greater intraoperative flexibility, efficiency, and precision, ultimately redefining the standard for minimally invasive spine surgery.    Key features include: Versatile tulip options: Choose from standard or high-strength configurations, with polyaxial or favored angle (M/L or C/C) options to address a wide range of surgical needs. Precision-engineered screw shanks: Available in diameters from 4.5mm to 9.5mm and lengths from 25mm to 100mm, featuring a rigid closed-top structure for advanced control and up to 20mm of built-in threaded reduction for seamless alignment. Advanced rod options: Select from 5.5mm or 6.0mm diameters in titanium or cobalt chrome, with lordotic, kyphotic, or straight profiles. Self-dissecting bullet tips and in-situ rod manipulation features simplify implantation and enhance surgical efficiency. Intraoperative flexibility: Customizable workflows with multiple technique options to accommodate surgeon preferences and case-specific needs.   Astura Medical is advancing MIS solutions that prioritize both patient and surgeon needs. If you’re interested in learning more about how this system or other aspects of our portfolio could enhance things for you, please visit our website at: asturamedical.com   #qualitydriven #surgeoninspired #spine #spinesurgeon #spinesurgeory Joel Gambrell | Thomas Purcell | Steve Haayen | Brett Heim | Matthew Twite | Blake Heim