Medical Device Developments

😎 The 5G future Technological advancements are radically changing how surgeons can conduct surgeries remotely in new and exciting ways. They also have the potential to free up staff time – and slash waiting lists for treatments. But can 5G connectivity keep up to deliver this new world of medicine, and what is still needed to unlock these new opportunities? Lauren Hurrell talks to Mischa Dohler, VP of emerging technology at Ericsson, to learn more. Over the past half-decade, 5G has become ubiquitous. That’s clear enough if you examine the statistics, with 5G subscriptions set to soar globally over the years ahead. During the third quarter of 2023, to give one example, 163 million global 5G subscriptions were added – pushing the total to 1.4 billion, even as users are forecasted to exceed 5.3 billion in 2029. Read more online: https://lnkd.in/ginS2M6g 📰 Follow Medical Device Developments to receive the latest medical device news daily and to subscribe to our weekly newsletter

🫘 Paragonix Technologies, Inc., Vanderbilt Health achieve kidney transplant milestone with KidneyVault system The system, which has received clearance from the FDA, is a portable hypothermic perfusion technology intended for the preservation and transportation of donor kidneys. Vanderbilt Health is the first facility in Tennessee and among the initial adopters in the Southeast to implement this system for kidney transportation, said Paragonix. The integration of the KidneyVault system marks a significant step in Vanderbilt’s strategy to incorporate advanced technology within the organ transplantation process. This approach enables Vanderbilt to treat a broader range of patients, including those considered high-risk who might not qualify for transplants at other medical institutions. Read more online: https://lnkd.in/gB_Ea9Au 📰 Follow Medical Device Developments to receive the latest medical device news daily and to subscribe to our weekly newsletter

🩸 Surmodics, Inc. launches Pounce XL System for non-surgical clot removal The system is designed for rapid endovascular removal of thrombi and emboli from arteries with diameters of 5.5-10 mm, complementing existing systems for smaller vessel sizes. It is intended for use in iliac and femoral arteries, enhancing the Pounce Thrombectomy Platform’s capability to address vessel diameters ranging from 2–10 mm. The fully mechanical system provides a standalone solution for removing peripheral arterial thrombi and emboli in both the lower and upper extremities. Read more online: https://lnkd.in/gyHTgavE 📰 Follow Medical Device Developments to receive the latest medical device news daily and to subscribe to our weekly newsletter

🍁 Guardant Health, Bayshore HealthCare partner to expand oncology testing in Canada The collaboration aims to enhance cancer care by offering advanced testing through Bayshore’s extensive network of clinics. It will focus on improving the quality of life for Canadians by providing access to advanced cancer diagnostics. Bayshore HealthCare offers home and community healthcare services to more than 350,000 clients through its 80+ home care offices, 11 pharmacies, and 100+ community care clinics. The partnership will allow Bayshore to offer advanced cancer testing tools, significantly expanding access for its healthcare providers and patients. Bayshore clinics will offer Guardant360 tests for therapy selection in advanced cancer. Read more online: https://lnkd.in/g5K3b4nH 📰 Follow Medical Device Developments to receive the latest medical device news daily and to subscribe to our weekly newsletter

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🧬 GeneDx expands into genetic testing for Inborn Errors of Immunity The expansion aligns with GeneDx’s mission to enhance patient outcomes by offering exome and genome testing solutions to a broader patient base, now including those with inherited immunological disorders. The focus on IEIs allows GeneDx to improve patient care by implementing exome and genome testing. This approach provides clinicians with precise and comprehensive genetic insights, aiding in the treatment of patients with these conditions. Clinicians dealing with IEIs are increasingly acknowledging the significance of genetic testing. With the rapid advancements in gene-disease discovery within the IEI domain, exome and genome sequencing are proving more effective than panel-based testing in keeping pace with new developments, said GeneDx. Read more online: https://lnkd.in/eqTqkX4y 📰 Follow Medical Device Developments to receive the latest medical device news daily and to subscribe to our weekly newsletter

🫁 Makani Science gets FDA 510(k) clearance for wearable respiratory monitor The company’s respiratory monitor is designed to track breathing rate continuously in real time through a lightweight, wireless form factor. Unlike conventional respiratory monitors that rely on wired connections and provide delayed data, the Makani Science device transmits information directly to iOS-compatible platforms, making it accessible to both patients and healthcare providers. Makani Science stated that the device had undergone extensive clinical and technical testing prior to regulatory approval. These evaluations demonstrated its operational accuracy and reliability in both clinical environments and real-world conditions. Read more online: https://lnkd.in/eKQCvk9g Video courtesy of Makani Science 📰 Follow Medical Device Developments to receive the latest medical device news daily and to subscribe to our weekly newsletter

🧭 Medivis secures FDA approval for Spine Navigation platform The Spine Navigation platform leverages augmented reality (AR) and artificial intelligence (AI) and can be used in both neurosurgery and orthopaedic surgery. It provides surgeons with holographic navigation for both open and minimally invasive spine procedures. The platform features surgical intelligence that combines proprietary computer vision algorithms, AI segmentation, real-time data analysis, and advanced image processing. The elements work together to deliver precise, context-aware insights throughout the surgical workflow, enhancing the overall surgical experience. Video Courtesy of Medivis Read more online: https://lnkd.in/eu96nNnM 📰 Follow Medical Device Developments to receive the latest medical device news daily and to subscribe to our weekly newsletter

🦿 restor3d receives FDA clearance for cementless 3D-printed personalised knee implant system The 510(k) authorisation allows the orthopaedic technology company to proceed with a limited commercial release of the device in Q3 2025. The newly approved implant is designed as a fully personalised total knee replacement system and includes cementless femoral, tibial, and patellar components. Developed using 3D-printed porous technology, the system is intended to support osseointegration and load-bearing capability without requiring cement-based fixation. This product represents the first cementless implant offering in Restor3d’s Identity knee platform. Read more online: https://lnkd.in/gGGcyngy 📰 Follow Medical Device Developments to receive the latest medical device news daily and to subscribe to our weekly newsletter

🦟QIAGEN launches QIAprep Plasmodium Kit to enhance malaria research QIAprep Plasmodium Kit combines sample preparation and quantitative PCR (qPCR) into a single workflow, providing a quick method to detect malaria parasites from blood samples. The advanced solution simplifies malaria research by enabling the detection of all five Plasmodium species in human samples. Qiagen’s QIAprep technology, initially developed for Covid-19 research, integrates liquid-based sample preparation with qPCR into a streamlined and cost-efficient workflow. It offers high sensitivity, detecting as little as one parasite per microlitre, and is compatible with both liquid and dried blood samples, including QIAcard FTA cards. Read more online: https://lnkd.in/g82_qFut 📰 Follow Medical Device Developments to receive the latest medical device news daily and to subscribe to our weekly newsletter