☑️ FDA issues a Class I recall for Medtronic’s brain surgery software due to potentially misleading text instructions. ☑️ Enspectra Health, Inc. receives breakthrough status for its AI-powered skin imaging platform, VIO Skin, for detecting certain skin cancers. ☑️ Eyebot wins $6 million to deploy rapid eye testing technology, focusing initially on the US market. ☑️ BillionToOne has unveiled results from a comparison study of its tumor profiling test, NorthStar Select, indicating significant benefits for patients with low circulating tumor DNA (ctDNA) levels. ☑️ restor3d secures $70 million to advance the development of 3D-printed implants for ankle and shoulder replacements. #InsightswithSmarteeva #Medtech #complaintmanagement #Pharma #Smarteeva #biotech #medtechtrends #medtechindustry #medicaltechnology #technology #health #medicaldevicediagnostics #ai #mdr #recalls #complaints #mir #fda #cvr
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Patients diagnosed with #heart disease, #cancer and other ailments face myriad decisions: Which drug will be most effective? Will the side effects outweigh the benefits? Will #surgery be enough? Determining the best path forward may be far easier in years to come. Instead of trying a therapy and hoping it works, researchers are creating so-called digital twins to predict how a patient will respond before ever starting treatment. In a Baltimore lab, Natalia Trayanova and her team at The Johns Hopkins University are creating computational models of hearts. Each one mirrors the heart of a real patient with a potentially fatal arrhythmia, an irregular heartbeat that is often a result of scarring from heart attacks or other conditions. The replicas, or “digital twins,” appear as personalized 3-D hearts on computers, with areas of scarring shown in white. The team can use them to model how and where to make new tiny scars through a procedure called ablation to fix the arrhythmia. #healthcare
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We are thrilled to share positive topline results from our pivotal clinical trial evaluating the Perimeter B-Series OCT system, combining #artificialintelligence technology with optical coherence tomography (OCT), for use in breast-conserving surgeries (BCS). https://bit.ly/3OiG6is • B-Series super-superiority based on predefined clinical and statistical significance parameters • Primary endpoint met indicating a statistically significant reduction in patients with residual cancer during surgery (p-value = 0.0050) • Intraoperative margin assessment during BCS using Perimeter B-Series OCT with ImgAssist AI 2.0 enabled surgeons to more effectively address residual cancer at the surgical margin as compared to current standard methods • FDA PMA application for B-Series OCT system with ImgAssist AI expected to be submitted in early 2025 This is a significant milestone, and we sincerely thank the Perimeter Medical Imaging AI team, clinical trial investigators, and most importantly, the patients who helped us get here. $PINK.V $PYNKF #medtech #AI #AIinhealthcare
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Breast surgeons will know its the #DCIS that impacts positive margin rates after #breastconservingsurgery, but here when we evaluated the exact pathological entity causing margin positivity we found DCIS increased the risk x9 !. Incredble effort from Hemali Chauhan and the team. To be effective, #intraoperative #margin #technologies will need to better map the boundaries of DCIS. 👉 https://lnkd.in/ebFhiJpj
Clinicopathological Predictors of Positive Resection Margins in Breast-Conserving Surgery - PubMed
pubmed.ncbi.nlm.nih.gov
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🔍 𝗧𝗵𝗲 𝗥𝗼𝗹𝗲 𝗼𝗳 𝗜𝗺𝗮𝗴𝗶𝗻𝗴 𝗠𝗼𝗱𝗮𝗹𝗶𝘁𝗶𝗲𝘀 𝗶𝗻 𝗕𝗿𝗮𝗶𝗻 𝗧𝘂𝗺𝗼𝗿 𝗦𝘂𝗿𝗴𝗲𝗿𝘆 𝗣𝗹𝗮𝗻𝗻𝗶𝗻𝗴 🧠 At Easiofy Solutions, we understand the critical role of imaging modalities like #MRI, CT, and PET scans in brain tumour surgery planning. These technologies are key in achieving precise tumour characterisation and delineation, essential for effective radiotherapy planning. MRI for brain tumour and #CT for brain tumour provide detailed anatomical insights, while PET scans for brain tumour offer crucial functional imaging. Combining these modalities, known as trimodality imaging or PET/CT/MRI trimodality, revolutionises three-dimensional tumour visualisation. This integrated approach surpasses individual imaging techniques' limitations, enhancing tumour contouring's accuracy. A PET/MRI fusion can be combined with a planning CT, or a PET/CT can be registered to an MRI for a comprehensive view. This trimodal approach ensures optimal imaging in the treatment position, often utilising a patient transfer system to minimise movement. With MRI compatible equipment and high-performance MRI coils, we can maximise the synergistic effects of these technologies. The impact of this advanced imaging is profound, especially for brain tumour imaging. The precision and inter-observer agreement achieved through trimodality imaging is transforming clinical routines and outcomes. #BrainTumorSurgeryPlanning #ImagingModalities #MRIForBrainTumor #CTForBrainTumor #PETScansForBrainTumor #TumorCharacterization #TumorDelineation #TrimodalityImaging #RadiotherapyPlanning #ThreeDimensionalVisualization #FunctionalImaging #AnatomicalImaging #PETMRIFusion #PlanningCT #PseudoCT #PatientTransferSystem #MRICoils #HeadAndNeckCancerImaging #BrainTumorImaging
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There are around 14,300 cases of spinal cord tumour*, 28,000 cases of brain tumors reported in India** and also high occurrence of Intracranial aneurysm which is 3% -5% of general population in India each year#. The complexity of their treatment has been the most pronounced challenge. With Intraoperative ultrasound (IOUS), surgeons are now able to localize deep-seated lesions under a real-time ultrasonic image display without dissection. Committed to empowering surgeons to make critical decisions that allow for better care, faster procedures, and reduced complications, GE HealthCare introduces bkActiv for neurosurgeons. The bkActiv Ultrasound system brings state-of-the-art capabilities of intraoperative, real-time, high-resolution imaging enabling precision-led effective surgeries. *Source: https://lnkd.in/g3HKRNmm **Source: https://lnkd.in/gQax3Mh7 #Source: https://lnkd.in/gEPe8vrF Chaitanya Sarawate, AnupKumar Ramachandran, Gourav Bakshi, Aishwarya Rao, Geet Kalra, Jayanta Shaw, Gurusamy Murugan #Healthcare #Medtech #Ultrasound
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Advancements in Navigational Bronchoscopy with Cios Spin 3D CBCT As I prepare for an upcoming meeting with a customer, I've encountered an insightful article that I believe will be of great interest to you. The article highlights the advantages of utilizing the Cios Spin 3D CBCT technology during navigational bronchoscopy procedures. Cios Spin enhances the procedure by ensuring 100% tool-in-lesion confirmation during lung biopsies. We recognize that physicians are mission-driven, and as a dedicated vendor, our goal is to equip them with the tools necessary for success, offering reassurance throughout and following the procedure. I would like to pose a question for reflection: Which is more paramount—the duration of the procedure or the confirmation of reaching the targeted lesion? The consensus often points to both. However, without definitive knowledge of the tissue sampled, a physician may continually question the procedure's accuracy. "Did I reach the lesion?" This concern is precisely what Cios Spin addresses, both today and in the future. Furthermore, we actively engage with healthcare executives, aiming to surpass their expectations as a vendor. Cios Spin not only underscores the potential for downstream revenue (ROI) but also emphasizes robust cybersecurity measures to ensure data remains secure and encrypted. As long as there’s breath in our lungs our story is still being written.” — Bart Millard Read article: https://lnkd.in/gn9rQVPN #kentucky #spin #3dimaging #CBCT #pulmonology #surgery #radiology #imaging #roboticsurgery #medicaldevice #siemens
Combining Shape-Sensing Robotic Bronchoscopy With Mobile Three-Dimensional Imaging to Verify Tool-in-Lesion and Overcome Divergence: A Pilot Study
ncbi.nlm.nih.gov
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You have choices when it comes to tumor localization. Explore replacing tumor localization with Surgical Marker Navigation. Visit Sirius Medical #ASBrS24, Booth 117. The American Society of Breast Surgeons, TME Breast Care Network, Learn Look Locate, #breastcancerawareness, #Pintuition, #innovation
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🤖 Medical Microinstruments, Inc. announced the Symani surgical robotics platform’s first clinical cases in the U.S, which were reconstructive extremity microsurgeries. 🎉MMI CEO Mark Toland called the first U.S. cases “a paramount milestone in the global expansion of the Symani Surgical System." He added: "Today marks the beginning of a new era in surgical innovation, as patients across the country with conditions that require complex microsurgical techniques, such as extremity reconstruction, autologous breast reconstruction post cancer resection and lymphedema repair, will now have expanded access to treatment options." 👉Read more: https://lnkd.in/dPBUktas 📰 Follow Guided Solutions to receive the latest #MedTech news daily and subscribe to our weekly newsletter: https://lnkd.in/dakx4h67 #MedicalDevices #MedicalDevice #MedicalEquipment #Medicine #Surgeons #GuidedSolutions
MMI’s Symani surgical robot used in first U.S. clinical cases
https://news.gsmedtech.com
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Happy to share our latest paper titled “Stereotactic Navigation-Assisted Laparoscopic Resection of Challenging Low Pelvic Tumors: A Case Series” #StereotacticNavigation is a real-time image guidance technique that optimizes #safety, #accuracy, and #precision when dissecting challenging low pelvic tumors We describe the step by step technique using the StealthStation™ S8 surgical navigation system (Medtronic) 1) Preoperative CT with 8 skin-fixed fiducials 2) Loading images on a navigation system 3) Patient tracker and patient-to-image paired point registration 4) Instrument tracker mounted on a laparoscopic instrument and calibrated for instrument tracking We report 3 cases that benefit from this technique - Bulky retro rectal cancer abutting the sacral nerve - Pelvic lateral recurrence - Advanced anal cancer for S4 identification during ELAPE Originating from neurosurgery, #SterotacticNavigation proves the need to interact between different surgical oncology specialists to optimize our outcomes Can’t wait to see its development in robotics! Link to free paper: https://lnkd.in/edMqXFMZ Jim Khan Korea University Anam Hospital Portsmouth Hospitals University NHS Trust Sam Atallah Michele Diana Theo Ruers Shan Li SEUNG JOON IM Tim Grage Intuitive Medtronic Robotic-Assisted Surgery MediThinQ Publication #64
Stereotactic Navigation-Assisted Laparoscopic Resection of Challenging Low Pelvic Tumors: A Case Series
mdpi.com
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