Medical Device Developments的动态

Good News ??: Fresenius Medical Care has achieved a growth milestone of more than 14,000 U.S.-based patients using the Company’s NxStage Medical, Inc. systems to perform Home Hemodialysis (HHD) therapy through both Fresenius Kidney Care clinics and other providers. The company has launched in parallel the newest version of its home dialysis machine, the NxStage? Versi?HD with GuideMe Software, featuring enhancements designed to simplify treatment, increase ease of learning, and improve user experience. These achievements highlight the efficacy and reliability of the NxStage system in delivering safe, high-quality care to patients in the comfort of their homes. "We are proud to announce these achievements in our Home Therapies division," said Joe Turk, Executive Vice President and Global Head of Home Therapies at Fresenius Medical Care. "These accomplishments underscore our relentless commitment to continuous innovations that enable us to improve the lives of patients seeking the safety, convenience, and flexibility of home dialysis." Read more in the press release here: https://lnkd.in/db6wttYi Disclaimer: Intended for U.S. audiences only. #HomeDialysis #InnovationInHealthcare #NxStage #ProudToBeFME

Application season is here again! It's time to start thinking about your applications for NUB adjustments in 2025! ???? ? ??? The NUB application window for hospitals ends on October 31st, so don't miss your chance to prepare your NUB #reimbursement for innovative #medicaldevices. ? ??Now is the perfect moment to consider if it makes sense to go for an NUB and start on the steps to make sure the applications are successful.? ? ?? If you need help determining if an NUB is right for your medical device or technology or help with preparing your #NUB hospital applications for 2025, don't hesitate to book a consultation with AiM. #medtech #marketaccess

Did you know that even a minor deviation in IV infusion flow can significantly impact patient outcomes? Medical professionals depend on precise and reliable IV systems, as this allows them to focus more on patient care rather than constant equipment monitoring. Here’s how our Dynaflo 6000 Series micro pump addresses this challenge:?? - Short bursts of pneumatic pressure (up to 27 psi and 27 inHg) combat the challenges of long tubing and varied elevations, ensuring a consistent and reliable flow. - A max flow rate of 9.5 lpm (0.3 cfm) ensures the drug infusion system delivers medicine quickly and efficiently. Why does this matter? Pump precision directly supports medical professionals, minimizing the risk of complications and enhancing patient treatment outcomes. For medical device manufacturers, focusing on the mechanical specifics—like pressure capabilities and flow rates—translates to creating devices that not only meet but exceed clinical needs. How have precision and accuracy impacted your medical devices’ performance and patient care? We’d love to hear your stories. #Dynaflo #MicroPump #MedicalDevices #Engineering #PatientCare

Watch the video to discover how the CONOX 2D Monitor can enhance patient monitoring! At Fresenius Kabi MedTech, we're proud to introduce the CONOX 2D monitor—the only device on the market that exclusively uses EEG to monitor both the patient’s hypnotic state (qCON index) and the probability of response to nociceptive stimuli (qNOX index). Key Features: ?? Advanced spectrogram ?? Large touch screen with configurable modes ?? SEF trend display ?? Pediatric use ...and more benefits for your daily clinical practice! Ready to elevate your clinical practice? Connect with our team! #CONOXweek #Delirium #EEGMonitoring #Conox #CommittedToLife *Not all products listed or shown are available in all countries. Check with your Fresenius Kabi representative for availability. Refer to the Conox Operator’s Manual for a complete list of warnings and precautions associated with the use of these products???

?? RedDrop Dx wins FDA approval for RedDrop One blood collection device RedDrop Dx One, the company’s first product, is a prescription-use whole blood and plasma collection device for delivering whole blood and plasma. It is a virtually pain-free, low-cost, easy-to-use, whole blood and plasma collection and dispensing system for home health, point-of-care, centralised, and remote clinical trials. Unlike traditional blood collection methods, the device offers several key advantages including the ability to collect a large blood volume, enhanced reliability, and reduced user discomfort. RedDrop Dx CEO and co-founder Kris Buchanan said: “Receiving FDA Class II medical device clearance for RedDrop One, our industry-leading solution, allows us to play a crucial role in improving patient care by making blood collection more accessible, reliable, less painful, and with the highest quality. “This is particularly important for supporting decentralized clinical trials and a variety of testing applications, where our technology can help overcome common obstacles related to phlebotomy and ensure timely access to essential tests. “Demand for RedDrop One has never been higher as the industry has become more aware of our breakthrough technology. We look forward to leading the industry and realizing the potential of remote testing.” Read more online: https://lnkd.in/eNuJ6rsS ?? Follow?Medical Device Developments?to receive the latest medical device news daily and to subscribe to our weekly newsletter #MedicalDeviceDevelopments #reddropdx #bloodcollection

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Product Names: HeartMate Touch Communication System? Product Codes: See Recall Database Entry? Distribution Dates: May 7, 2020 to December 18, 2023? Devices Recalled in the U.S.: 1,560? Date Initiated by Firm: January 3, 2024 Who May be Affected? People who have the implantable HeartMate 3 Left Ventricular Assist Device. Health care providers who use the HeartMate Touch Communication System to monitor patients with HeartMate 3 Left Ventricular Assist Devices. FDA Medical device recall: https://lnkd.in/g6a3X2FY HeartMate 3 LVAD: https://lnkd.in/gm5trhWQ

Tips of the week: stay tuned on Fresenius Kabi MedTech Europe. The #CONOXweek will provide you with a lot of insight about qCON and qNOX index with #Conox 2D monitor! #CommittedToLife

Innovation in motion: Manner's Twist medical castors At Manner, we understand that precision, reliability, and ease of use are essential in medical environments. That's why our Twist-series medical castors are designed to meet the highest standards for demanding healthcare applications. Key features: ? Effortless maneuverability with a twin-wheel design. ? Easy-to-use brake pedal, enabling secure positioning. Applications in action: ? mobile operating chairs – foot-activated locking ensures stability during procedures ? doctor’s chairs – enhances efficiency with smooth, controlled movement ? radiopharmaceutical devices – used in multidose injectors for diagnosing and treating diseases like cancer With Manner’s Twist castors, we bring mobility and precision to healthcare professionals, helping them focus on what truly matters – patient care. #MannerCastors #MedicalInnovation #HealthcareMobility #PrecisionEngineering #ColsonGroup #Twistcastors #medicalcastors #Healthcaretechnology

A Pioneer In Development The story of Shockwave Medical is nothing short of a love affair with innovation. ??2019: A pivotal moment unfolded as the FDA granted Shockwave Coronary IVL system with a Breakthrough ?Device Designation (BDD). A testament to our commitment to pushing the boundaries. ??2020: Building on the momentum, CMS granted new codes for Shockwave’s peripheral IVL, solidifying our presence in the evolving landscape of medical advancements. ??2021: A year of significant milestones as CMS grants Out-patient Transitional Pass-Through (TPT) and In-patient New Technology Add-on Payment (NTAP) reimbursement. A nod to the economic viability and clinical value we bring to the healthcare community. ??2022: Establishing our mark with the creation of a Category III CPT code, showcasing our dedication to setting industry standards and defining excellence. ??2023: CMS took another bold step by introducing new hospital in-patient payment for Coronary IVL, reinforcing our role in reshaping the future of medical solutions. ??2024: A crowning achievement as CMS established a new Category I CPT add-on code for Coronary IVL, a recognition of our continuous commitment to excellence and innovation. I’m so honored to be apart of an innovative company who successfully united clinical value with economic value in such a short period of time. I am so impressed, yet not surprised at the same time.???

ZenFlex? CM taper .04, Gutta Percha ZenFlex. Canals Mesials until 20/.04, Canal Distal until 30/.04 “I liked that the pre-curving of the files prior to introducing into the canal was much easier and I believe it can be used on all kinds of canals.”- Dr. Rodrigo Vargas Contact a rep today to learn more: https://hubs.ly/Q02KwcyS0 Images provided by Dr. Rodrigo Vargas. Dr. Vargas is a not paid consultant of Kerr. The opinions expressed in this article are those of Dr. Vargas. Kerr is a medical device manufacture and does not dispense medical advice. Clinicians should use their own professional judgment in treating their patients. #Envista #kerr #zenflexcm