Medical Device Developments’ Post

👨💻 Medtronic gets FDA nod for expanded MRI labelling for DBS systems The US FDA has approved expanded MRI labelling for Medtronic Percept PC and Percept RC, as well as Medtronic Activa PC, RC and SC. The MRI labelling approval, which applies exclusively to Medtronic DBS systems, permits extended active scan time for scans within specified B1+rms limits. The approval enhances diagnostic and functional assessment options. Medtronic is claimed to be the first in the US to provide full-body MR Conditional DBS systems that enable patients to undergo scans anywhere on the body under specific conditions safely. Read more online: https://lnkd.in/eKQdZrfG 📰 Follow Medical Device Developments to receive the latest medical device news daily and to subscribe to our weekly newsletter #MedicalDeviceDevelopments #medicaldevices #medicalmanufacturing

The recall includes specific lots of five different medical devices used during neurovascular procedures.

🤖 Avicenna.AI secures FDA approval for AI-based VCF detection tool CINA-VCF is designed to detect unsuspected vertebral compression fractures (VCFs) in patients who are undergoing chest or abdomen CT scans. Its algorithm identifies and prioritises VCFs detected during routine CT scans for patients undergoing medical imaging for different health conditions and informs clinicians immediately. The medical AI company validated the tool on 474 CT scans, performed for other clinical indications than for VCF, on 38 different scanner models from four different manufacturers. Read more online: https://lnkd.in/e3tz7NCh 📰 Follow Medical Device Developments to receive the latest medical device news daily and to subscribe to our weekly newsletter #MedicalDeviceDevelopments #medicaldevices #medicalmanufacturing

💗 iRhythm Technologies, Inc. gets FDA 510(k) approval for design updates to Zio AT device The Zio AT device is a prescription-only outpatient cardiac telemetry device, commonly known as a mobile cardiac telemetry device, used for mobile cardiac telemetry (MCT) services. The system contains the Zio AT patch, an ECG monitor that continuously records ECG data for up to 14 days, and the company’s Zio ECG Utilization Software (ZEUS). It also includes a wireless gateway that provides connectivity between the Zio AT patch and ZEUS to transmit data during the wear period. Read more online: https://lnkd.in/evNqeh79 📰 Follow Medical Device Developments to receive the latest medical device news daily and to subscribe to our weekly newsletter #MedicalDeviceDevelopments #medicaldevices #medicalmanufacturing

SciChart’s charting software is used by 90% of top medical device companies globally. Whether you’re looking to pioneer a life-changing medical device, push the boundaries of research or enhance your healthcare service, with SciChart, you can. In this case study, learn how Avicena LLC used SciChart for Android to plot, in real time, their multi-series Cardiovascular Data for Medical Diagnostics. #medicaldevices #cardiovascular #medicaldata #chartlibrary #bigdata #datavisualization #casestudy

Convergence Medical received FDA Breakthrough Device designation in November 2023. This significant step brings us closer to achieving our goal of providing the V01 robot to hospitals across the USA. The FDA's Breakthrough Devices Program is a voluntary initiative for certain medical devices and device-led combination products that offer more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions. This designation not only underscores the potential impact of the V01 robot on improving surgical outcomes but also provides Convergence Medical with a unique opportunity to collaborate more closely with the FDA. By participating in the Breakthrough Devices Program, we can benefit from prioritised review and a more efficient regulatory process, which accelerates the pathway to market entry. This enables us to bring our innovative technology to healthcare providers and patients more quickly, ensuring that cutting-edge surgical solutions are available to those who need them most. To see more of our journey, visit us at convergenceortho.com and on LinkedIn, Facebook, and Instagram. #fdabreakthrough #convergencemedical #v01 #surgicalrobot #medicaldevices #arthroscopy

💗 Johnson & Johnson MedTech’s Impella ECP shows safety and efficacy in IDE study The IDE study is the first clinical trial completed on patients supported with Impella ECP, a novel transvalvular axial flow pump with compressible pump architecture. Impella ECP technology is developed by Abiomed, a company of Johnson & Johnson MedTech. The IDE study established the safety and efficacy of Impella ECP in high-risk percutaneous coronary intervention (PCI), with a major adverse cardiac and cerebrovascular events (MACCE) rate of 6.3%. Read more online: https://lnkd.in/e9_MiTst 📰 Follow Medical Device Developments to receive the latest medical device news daily and to subscribe to our weekly newsletter #MedicalDeviceDevelopments #medicaldevices #medicalmanufacturing

🔬 Breaking: FDA Approves Boston Scientific's Navigation-Enhanced PFA Catheter TL;DR: Boston Scientific secures FDA approval for their groundnavigation-equipped pulsed field ablation catheter. 🌟 Why This Matters: This milestone represents a major leap forward in atrial fibrillation treatment, combining precision navigation with advanced ablation technology. The approval signals a shift toward more sophisticated, minimally invasive cardiac solutions. 💡 Strategic Takeaways: • Navigation-integrated medical devices are gaining momentum • Precision technology is reshaping cardiac care standards • Market opportunities are expanding in smart medical devices 📈 Executive Action Items: 1. Evaluate partnerships with navigation tech developers 2. Monitor regulatory landscape for similar innovations 3. Assess portfolio alignment with this emerging trend What's your take on navigation-integrated medical devices? Share your thoughts on how this approval might influence the future of cardiac care. #BiotechInnovation #MedicalDevices #Healthcare #FDA #CardiacCare

Explore the “5 Benefits of Automated Ultrasound Probe Disinfection” in the current post to the CME Insider’s Blog. With the growing use and application of ultrasound imaging technology, the FDA, CDC, federal and international organizations, and TJC all utilize Spaulding Classification to determine appropriate levels of disinfection for reusable medical devices. A probe contacting non-intact skin, mucous membrane, sterile tissue, or bloodstream requires high level disinfection (HLD), making automated disinfection a healthcare facility essential. https://lnkd.in/ecfgpsRV #cmecorp

💓 New data demonstrates Vektor Medical, Inc.’s AI-powered vMap algorithm achieves 91% accuracy in distinguishing epicardial and endocardial ventricular tachycardia Vektor Medical, a leader in non-invasive arrhythmia analysis and localization, announced today the presentation of new data showcasing the significant capabilities of vMap, its AI-powered solution for enhancing cardiac arrhythmia treatment. To be presented on November 17 at the American Heart Association (AHA) Scientific Sessions 2024, this data highlights vMap’s impressive 91.1% accuracy rate in differentiating epicardial from endocardial ventricular tachycardia, outperforming traditional visual ECG analysis, which achieved only 62.5% accuracy. The vMap algorithm demonstrated 91.1% accuracy and an impressive sensitivity of 97.1%, significantly outmatching the top-performing visual ECG methods. Read more online: https://lnkd.in/gcNABR_E 📰 Follow Medical Device Developments to receive the latest medical device news daily and to subscribe to our weekly newsletter #MedicalDeviceDevelopments #medicaldevices #medicalmanufacturing