The FDA-approved EFS trial, led by Drs. Ron Waksman and Lowell Satler, focused on evaluating the J-Valve™ TF system in symptomatic individuals with severe Aortic Regurgitation. The J-Valve™ TF System, developed by JC Medical, has shown promise in treating patients with aortic regurgitation and has been granted Breakthrough Device designation for this indication. Dr. Mark A. Turco, CEO of JC Medical, expressed gratitude to the investigators and research teams involved and anticipates data from the trial to inform the upcoming Pivotal Trial.
Roche Diagnostics’ Elecsys Anti-Müllerian Hormone (AMH) Plus immunoassay has been extended to detect polycystic ovarian morphology (PCOM), aiding in the diagnosis of polycystic ovary syndrome (PCOS). This expansion follows an update to the Rotterdam Criteria, recommending elevated AMH levels as an indicator of PCOM, providing an alternative to transvaginal ultrasounds, which can be discomforting for some patients. The innovation aims to facilitate earlier and more accessible diagnosis of PCOS, addressing the significant portion of undiagnosed cases and reducing the long-term consequences of the condition.
A study led by Wynn Legon and his team at the Fralin Biomedical Research Institute at VTC suggests that low-intensity focused ultrasound targeted at the brain’s insula can reduce pain perception and related physiological responses, as published in the journal PAIN. Using focused ultrasound, the researchers found that participants experienced a significant reduction in pain perception and stress-related physiological changes, indicating a potential non-invasive method for managing pain and reducing the need for opioids.
Tuesday, February 6th
Trelleborg Group is set to acquire Baron Group, a leading Australian-Chinese manufacturer of precision silicone components for medical technology applications, strengthening Trelleborg’s position in healthcare. With the acquisition, Trelleborg aims to enhance its application expertise and manufacturing capacity, expanding its global presence and meeting the growing demand for medical technology products in areas like sleep apnea and respiratory care. The acquisition, valued at USD 300 million, includes potential additional consideration of up to USD 100 million based on performance, and is expected to be finalized in the first half of 2024, pending regulatory approval.
Dexcom launches its latest continuous glucose monitor (CGM) system, the Dexcom ONE+, initially rolling it out in Spain, Belgium, and Poland, with plans for a launch in the Netherlands next week. The system, designed based on user and healthcare professional feedback, aims to provide an easy-to-use and highly effective CGM experience for individuals managing type 1 or type 2 diabetes with insulin, utilizing the latest-generation G7 sensor. CEO Kevin Sayer anticipates completing the transition from the previous G6 sensor during the first quarter of 2024.
US-based medical devices company Procyrion has secured $57.7m in a successful Series E funding round led by Fannin Partners, with contributions from new and existing investors. The funding will support the pivotal DRAIN-HF IDE trial of the Aortix pMCS device designed to aid patients with acute decompensated heart failure (ADHF) who are not responding to standard medical therapy, as well as enhance product manufacturability and facilitate commercialization efforts.
Wednesday, February 7th
A multi-institutional research team led by Dr. Kazuya Nishino analyzed 61 knees with discoid lateral meniscus surgery (symptomatic group) and 35 knees with discoid lateral meniscus detected on MRI (asymptomatic group) to understand why some patients with specific joint deformities are symptomatic while others are not. The study revealed that the symptomatic group had a higher percentage of meniscus covering the tibia and greater meniscal height compared to the asymptomatic group, suggesting that preoperative imaging can help determine the amount of tissue resection required for patients with symptomatic discoid lateral meniscus. Additionally, MRIs of symptomatic patients showed meniscal tears or other evidence of instability, suggesting that these morphological features could contribute to symptoms in symptomatic patients.
Innova Vascular, Inc. has announced the successful early commercial use of its Laguna Thrombectomy System™ at UCLA Medical Center and Providence St. Joseph Hospital in California. Physicians have reported positively on the system’s easy prep, excellent trackability, and highly effective clot extraction, with Dr. Raj Khalsa from Providence St. Joseph Hospital praising its simplicity and efficiency, while Dr. John Moriarty from UCLA David Geffen School of Medicine highlighted its navigability and ease of use, emphasizing its value in treating venous thromboembolism.
Researchers at Johns Hopkins University have developed a new algorithm, called DeepSTI, that enhances magnetic resonance imaging (MRI) by providing a “super-scan” with precise brain tissue susceptibility information. This algorithm, based on susceptibility tensor imaging (STI), requires fewer scans and positions compared to traditional STI, making the process faster and more patient-friendly, with potential applications in understanding and diagnosing neurological diseases like multiple sclerosis (MS) and Alzheimer’s. The algorithm’s machine learning capabilities, utilizing regularization techniques, enable it to reconstruct high-resolution 3D maps of magnetic susceptibility in the brain, potentially making STI more affordable and accessible while enhancing image quality for clinical and research purposes.
Thursday, February 8th
University of Washington researchers have developed the Thermal Earring, a wireless wearable that continuously monitors earlobe temperature and outperforms smartwatches at sensing skin temperature during rest periods. The earring, which is about the size of a small paperclip and has a 28-day battery life, can be personalized with fashion designs and gemstones while accurately monitoring signs of stress, eating, exercise, and ovulation, potentially offering a more fashionable and effective alternative to traditional health-tracking wearables. While the device’s potential applications show promise, further research and testing are needed before it becomes commercially available.
Confluent Medical Technologies and ATI are partnering to invest over $50 million in expanding ATI’s Nitinol melt and materials conversion infrastructure, aiming to triple its medical Nitinol melt capacity. The investment addresses the increasing demand for Nitinol in neurovascular, electrophysiology, structural heart, peripheral vascular, and orthopedic device markets, ensuring a reliable supply chain for life-saving medical devices while positioning Confluent as ATI’s fulfillment partner and provider of value-add services.
Fresenius Medical Care has received FDA clearance for its 5008X hemodialysis system, paving the way for U.S.-based clinical evaluations and user studies ahead of a planned broad launch in 2025. The system offers high-volume hemodiafiltration therapy, incorporating advanced device engineering and membrane technologies to enable efficient removal of larger molecules and fluid replacement, potentially reducing mortality rates by 23% compared to traditional methods. Helen Giza, CEO of Fresenius Medical Care AG, emphasized the company’s commitment to innovation and improving the lives of patients with kidney diseases, marking the clearance as a significant step toward introducing a new standard of dialysis care in the U.S.
Friday, February 9th
GE HealthCare has embarked on a three-year collaboration with MedQuest Associates, aiming to enhance outpatient imaging centers with new medical device technology and digital tools. Through this partnership, GE HealthCare’s advanced technologies will be integrated with MedQuest’s infrastructure to optimize multi-site imaging networks, introduce Theranostics solutions, and improve patient care quality in ambulatory settings. This strategic move aligns with GE HealthCare’s commitment to providing intelligent data and smart devices to enable clinicians to make faster, more informed decisions and improve patient outcomes, while positioning MedQuest at the forefront of innovative care delivery.
Viz.ai has obtained FDA 510(k) clearance for its Viz ICH Plus algorithm, designed to automate the measurement of brain bleeds on non-contrast computed tomography (NCCT) images. This algorithm aids clinicians in swiftly assessing the severity of intracerebral hemorrhage cases, enabling timely treatment decisions and potentially transforming the approach to such cases. Dr. Peter Kan from the University of Texas Medical Branch noted that the algorithm’s precision and AI capabilities significantly enhance decision-making in neurosurgery, highlighting its potential to improve patient outcomes.
RaySearch (publ) has acquired DrugLog™ from Pharmacolog AB for SEK 7 million, aiming to enhance cancer treatment verification processes. DrugLog’s quick and reliable measuring device verifies cytostatic compounds, ensuring correct drug concentration for chemotherapy, with plans to integrate it into RaySearch’s oncology software portfolio, promising improved care for cancer patients globally.
ThinkMedTek 
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