TÜV SÜD - Healthcare & Medical Devices’ Post

🏥 Imperative Care gets FDA approval for Zoom 6F Insert Catheters According to Imperative Care, Zoom 6F represents the first insert catheter portfolio specifically developed for ischemic stroke procedures, based on physician feedback. The portfolio includes the Zoom SIM, Zoom VRT, and Zoom VTK technologies, with unique shapes, construction, and length, to help physicians achieve faster intracranial access. Imperative Care said that its catheters are designed to be more supportive, more torque-able and longer than current vessel selection devices. Read more online: https://lnkd.in/eJ22TBhM 📰 Follow Medical Device Developments to receive the latest medical device news daily and to subscribe to our weekly newsletter #MedicalDeviceDevelopments #medicaldevices #medicalmanufacturing

WorldThrombosisDay may have passed, but the mission to raise awareness about thrombosis continues. At Argon Medical Devices, we understand the importance of innovation in the treatment of this condition. That’s why we have launched the CLEANER Vac™ Thrombectomy System—a tool designed to quickly and effectively remove thrombus. By providing efficient and total control throughout peripheral venous thrombectomy procedures, CLEANER Vac offers a new option for physicians targeting shorter procedure times, lower costs, and minimized blood loss. Let’s keep working together to combat thrombosis and support those affected by this condition. Learn more: https://lnkd.in/gyF5A4A4 Rx only

#medicaldevices #caediovascuarimplans #endovasculardevices #iso25539 #biocompatibilitytests 🫀List of Biocompatibility tests as per ISO 25539 for implantable devices and it's importance 👉ISO 25539 is a standard for cardiovascular implants, including endovascular devices. Biocompatibility tests required by ISO 25539 include: 🌱Cytotoxicity testing 🌱Sensitization testing 🌱Irritation or intracutaneous reactivity testing 🌱Systemic toxicity testing 🌱Subchronic toxicity testing 🌱Genotoxicity testing Carcinogenicity testing 🌱Implantation testing 🎯The importance of these tests lies in ensuring that implantable devices are safe for use within the human body. They assess the potential risks associated with the materials used in the devices, ensuring they do not cause adverse reactions such as inflammation, toxicity, or immune responses when implanted. These tests are critical for regulatory approval and ultimately for ensuring patient safety and wellbeing.

In our quest for excellence in #MedicalDevice development, the concept of indirect contact as defined by ISO 10993-1 is pivotal. It describes a scenario where a device or component allows the passage of fluids or gases to body tissues without direct contact. To gauge our collective understanding, I pose the following multiple-choice question: 🔍 Which of these medical devices typically operates based on the principle of indirect contact? A) Stethoscope B) Heart valve C) Intravenous (IV) set D) Pacemaker Drop your selection in comments below! #Biocompatibility #RiskManagement #ISOStandards #HealthcareQuality #QualityAssurance

Penumbra, Inc. Revolutionizes Clot Removal with Lightning Flash 2.0 Exciting news in the world of cardiovascular care! Penumbra, a leading medical device company, has announced the FDA approval and commercialization of its latest innovation, the Lightning Flash 2.0 system. Lightning Flash 2.0 is the next-generation computer-assisted vacuum thrombectomy (CAVT) system designed to rapidly remove venous thrombus and treat pulmonary emboli (PE). Featuring advanced algorithms for increased speed and sensitivity, this system, combined with Penumbra's novel catheter technology, empowers physicians to navigate complex anatomy and deliver superior clot removal with minimal blood loss. According to Penumbra's FSIR chief medical officer, James F. Benenati, M.D., FSIR, "Lightning Flash 2.0 has significantly improved procedure time by shortening the aspiration time and shown reductions in blood removed during aspiration. These advantages can improve patient safety, provide better outcomes, and streamline efficiency for physicians."As the only computer-assisted mechanical thrombectomy systems currently available in the US, Penumbra's Lightning family of products continues to push the boundaries of cardiovascular care. With the launch of Lightning Flash 2.0, the company reaffirms its commitment to advancing patient care and ensuring more individuals can benefit from this transformative technology. https://lnkd.in/eAKaenfB Be sure to follow Practical Patient Care on LinkedIn for more industry news and insights. #PracticalPatientCare #MedicalDevices #CardiovascularCare #ThrombectomyInnovation

As someone who's lived more than half my life with extensive, permanently-implanted surgical hardware, I was shocked and scared when I first learned just how little clinical evidence goes into most medical device authorizations from the FDA. Adding to the issue: A new analysis of the most serious, potentially life-threatening recalls of cardiovascular devices shows that the vast majority weren't tested on patients before authorization — they were "moderate risk" devices, cleared through the more lenient 510(k) process. Maybe all those safety recalls, one researcher said, mean those devices weren't "moderate risk" in the first place. Read more in STAT:

🔦 Strata Skin Sciences secures Japan’s MHLW approval for XTRAC Momentum device XTRAC Momentum is the next-generation excimer laser system that facilitates the precise delivery of targeted UVB light to treat specific areas on the skin. The excimer laser can be used for both adult and paediatric patients suffering from inflammatory skin conditions such as psoriasis, atopic dermatitis, and vitiligo. The medical device company plans to commercially launch the device in Japan through JMEC, its established strategic partner and distributor in Japan. Read more online: https://lnkd.in/eT3Nqnyk 📰 Follow Medical Device Developments to receive the latest medical device news daily and to subscribe to our weekly newsletter #MedicalDeviceDevelopments #medicaldevices #medicalmanufacturing

💉Penumbra, Inc. launches latest CAVT technology to rapidly remove blood clots Lightning Flash 2.0 is the next-generation computer-assisted vacuum thrombectomy (CAVT) system to remove venous thrombus and treat pulmonary emboli (PE). The next-gen CAVT system features advanced Lightning Flash algorithms designed for increased speed and sensitivity to thrombus and blood flow. Together with Penumbra, Inc.’s novel catheter technology, the system will help physicians better navigate through complex anatomy and deliver superior clot removal with minimal blood loss. Penumbra, Inc. FSIR chief medical officer James F. Benenati, M.D., FSIR said: “Based on what we’ve seen in the initial launch, Lightning Flash 2.0 has significantly improved procedure time by shortening the aspiration time. It has also shown reductions in blood removed during aspiration. “These advantages can improve patient safety, provide better outcomes for the patients and streamline efficiency for physicians treating the patients. “As adoption of thrombectomy becomes more widespread, Lightning Flash 2.0 will provide physicians with the confidence that CAVT is a valuable frontline option.” Read more online: https://lnkd.in/eAKaenfB 📰 Follow Medical Device Developments to receive the latest medical device news daily and to subscribe to our weekly newsletter #MedicalDeviceDevelopments #penumbra #bloodclots

💓 Reflow Medical recruits first patient in Spur Elute trial for in-stent restenosis The study, known as DEEPER CORONARY, will recruit 10 patients at up to three centres in New Zealand. New Zealand’s Wellington Hospital interventional cardiologist and trial principal investigator Scott Harding said: “It’s exciting to take part in the study of this novel platform, which has the potential to successfully treat patients suffering from in-stent restenosis.” Spur Elute addresses coronary ISR in patients by delivering a proprietary sirolimus drug formulation directly to the affected lesion without the use of a permanent metallic implant. Read more online: https://lnkd.in/ebBpZ3y4 📰 Follow Medical Device Developments to receive the latest medical device news daily and to subscribe to our weekly newsletter #MedicalDeviceDevelopments #medicaldevices #medicalmanufacturing

The 𝗠𝗖𝗧 𝗞𝗶𝘁® is a class IIa medical device produced in Spain and designed with the highest standards of quality and safety. Each MCT Kit® comes 𝘀𝘁𝗲𝗿𝗶𝗹𝗶𝘇𝗲𝗱 and is conveniently 𝗽𝗮𝗰𝗸𝗮𝗴𝗲𝗱 in an envelope. The 𝗹𝗮𝗯𝗲𝗹 on the package provides crucial information, including: - Expiration date of the cassette - Batch number - Medical Device (MD) designation - CE marking - Important safety notes: Not to be reused or resterilized to avoid the risk of infection At Meta Cell Technology we are committed to delivering innovative solutions that prioritize patient safety. Meta Cell Technology🧬, Breaking PRP and Exosomes limits. 📩 info@metacelltech.com 🔗 www.metacelltech.com #MCT #MCTKit #MedicalDevice #PatientSafety #BreakingPRPlimits #AutologousExosomes #RegenerativeMedecine