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Fujifilm’s Synapse 3D provides clinical decision support, speeds up workflow during COVID-19 emergency at Pisa University Hospital

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Pisa University Hospital has received support from Fujifilm Italia to improve and speed up the analysis of lung CT images which are important for the diagnosis of COVID-19. This has been possible thanks to an update by Fujifilm of the configuration of the Synapse 3D software used by emergency room radiologists.
The hospital says this new technological development has been useful to improving management of patients affected by COVID-19, during the emergency.
Synapse3D is a 3D medical image analysis system that uses Fujifilm’s image recognition technology to construct and analyze highprecision 3D images, compiled from tomographic images from CT and MRI. It delivers 3D visualization of medical images and has applications in image-based diagnosis and surgery simulation.
Synapse 3D delivers clinical value through fast, accurate, efficient and robust image processing for radiology, cardiology and surgical preoperation simulation.
It was developed in Japan (where it is named Synapse VINCENT) and it consists of more than 50 different processing modules.
The Synapse3D Lung Analysis/Airway module enables the analysis of density ranges in the lung in a quick, easy, objective and reproducible way.
At Pisa University Hospital the configuration of Synapse 3D was completed quickly, with the study of density ranges and a feasibility analysis carried out in a few days, meaning that this updated integrated workflow has been possible to use in the hospital since April 1.
The Pisa University Hospital had already set up three levels of assessing Coronavirus patients, and with the support of Synapse 3D software, doctors have had the ability to quickly and easily identify the stage of pneumonia, and therefore hospitalise patients accordingly:

  • normal hospitalisation for patients with mild pneumonia not requiring respiratory support
  • assessment by a pulmonologist or intensive care doctor for patients with moderate pneumonia to plan suitable respiratory support
  • intensive care assessment for patients with severe pneumonia with a view to transferring them to the intensive care unit

The density analysis provided by Synapse 3D has made it is possible to analyse the lung according to the different pixel densities of the CT images. Three groups were therefore defined based on different density ranges that allow the radiologist to evaluate the percentage of lung with lower density (emphysema), higher density (interstitial effort) and normal lung.
Dr. Chiara Romei, MD, PhD, Radiologist at the Pisa University Hospital, explained: “In a time of emergency such as this, it is crucial for us radiologists to detect accurate data as quickly as possible. Synapse 3D has enabled a quantitative analysis that is much faster and more objective than the visual analysis of the radiologist; in a couple of minutes it is possible to obtain data relating to the percentage of lung with greater and lesser density and to have a precise and objective, reproducible and shareable value.”
It is important to note that the data obtained by Synapse 3D does not replace the molecular diagnoses made through the nasopharyngeal swab (RT-PCR) and does not replace the analysis and diagnostic work by the radiologist, but instead it supports the reporting of daily exams to monitor and study the evolution of the disease, thus optimising workflow.
For medical professionals – download the take-away: https://synapse.fujifilm.eu/fujifilm-takeaway/
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Rapid diagnostics from whole blood for bacterial and fungal pathogens

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T2 Biosystems’ T2Bacteria® and T2Candida® Panels are the first and only FDA-cleared and CE-marked tests that identify the most serious bacterial and fungal pathogens directly from blood sample in just three to five hours, without waiting for a positive blood culture —which can take one to six or more days. These capabilities allow for faster species identification, enabling the potential for faster targeted treatment, de-escalation of empiric therapy and improved patient outcomes.
All T2Direct DiagnosticsTM panels are run on the T2Dx® Instrument using a patient’s blood sample with validated clinical sensitivity of 91 to 96% and specificity of 98 to 99%. The direct from blood capability is enabled by the proprietary T2MR-powered T2Dx® Instrument which can detect organisms at concentrations as low as 1 CFU/mL. This represents a thousandfold increase in sensitivity compared to products that detect species from positive blood culture bottles where the number of cells is typically in the range of 10,000 to 10,000,000 CFUs/mL.
T2 Biosystems recently received FDA Breakthrough Designation for the T2ResistanceTM Panel, a diagnostic panel that can detect 13 resistance genes from both gram-positive and gram-negative pathogens from a single patient blood sample in 3 to 5 hours. The T2Resistance Panel is also run on the T2Dx instrument and is expected to be CE-marked and available in Europe by the end of 2019, and offered as a Research Use Only product in the United States before yearend.
T2 Biosystems will showcase its latest innovations at ECCMID at Booth #1.22.

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Compact refrigerators for secure and sustainable clinical storage

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A new series of compact refrigerators has been specifically developed to address the need of clinical laboratories and patient care facilities for cold storage equipment that enable secure and energy-efficient storage of vaccines, medicines, lab kits and breast milk, while offering quiet operation and a small footprint. Powered by Phononic’s solid state cooling technology, the new TSG refrigerators have been designed to provide uninterrupted temperature stability and cleanroom-compatible readiness for reliable storage of the most sensitive materials. Furthermore, the systems offer quiet operation at less than 35 dbA, meaning they can be placed in clinical laboratories, nurse’s stations, and even patient rooms and intensive care units, without disrupting the work environment and patient comfort. With ENERGY STAR-rated performance, the TSG Series refrigerators consume significantly less energy than similar models, meeting clinical settings’ sustainability objectives and reducing operating costs. In addition, as they feature fewer refrigeration components compared to other available units, they require only minimal maintenance and offer increased storage capacity. The solid state technology used in the TSG Series allows for minimal impact on the clinical environment through reduced operational noise and heat output, while the systems’ small size maximizes working space. As with the Thermo Scientific TSX Series of freezers and refrigerators, the new TSG Series uses environmentally-friendly refrigerants in line with global initiatives aimed at minimizing greenhouse gas emissions. Additionally, the systems feature an alarm capability, notifying users of temperature fluctuations, door ajar and power failure, enabling for corrective action to ensure ideal storage conditions are always maintained throughout the internal chamber. The TSG Series refrigerators are available in undercounter (TSG505) and countertop (TSG205) configurations to suit varying application needs.
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Abbott receives CE Mark for TriClip, world’s first minimally invasive, clip-based tricuspid valve repair device

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Abbott has received the CE Mark for TriClip™ Transcatheter Tricuspid Valve Repair System which is now approved for use in Europe and other countries that recognize CE Mark. The device is used as a non-surgical treatment for people with a leaky tricuspid valve, a condition known as tricuspid regurgitation (TR).
With the CE Mark designation, Abbott’s TriClip device is the first minimally invasive, clip-based tricuspid valve repair device to be commercially available in the world.
Abbott is a global leader in developing transcatheter treatments for heart valve disorders and has brought to market three first-in-class therapies for structural heart disease: MitraClip for mitral valve repair, Tendyne™ for mitral valve replacement, and now TriClip to treat the tricuspid valve.
The tricuspid valve, often referred to as the “forgotten heart valve”, has three leaflets that control the flow of blood between the two chambers on the right side of the heart. When those leaflets do not close properly, blood can flow in the reverse direction – known as regurgitation – forcing the heart to work harder. When left untreated, TR can lead to conditions such as atrial fibrillation, heart failure, and ultimately, death. The condition is difficult to treat, however, and options for patients have historically been extremely limited. People with TR are typically older and suffer from multiple co-morbidities, making open-heart surgery a high-risk procedure.
The TriClip procedure repairs the tricuspid valve without the need for open-heart surgery. The device is delivered to the heart through the femoral vein in the leg and works by clipping together a portion of the leaflets of the tricuspid valve to reduce the backflow of blood. This approach allows the heart to pump blood more efficiently, relieving symptoms of TR and improving a person’s quality of life.
“Patients suffering from severe tricuspid regurgitation are extremely ill and have very few treatment options,” said Georg Nickenig, M.D., Ph.D., professor and chief, Department of Cardiology, University Hospital, Bonn, Germany, and lead investigator of the TRILUMINATE trial, which generated strong data that helped lead to the CE Mark of TriClip. “Abbott’s TriClip could profoundly impact how physicians treat these patients. The therapy is backed by data proving safety and performance, durability, and improved patient quality of life.”
The CE Mark for TriClip follows positive six-month data from Abbott’s pivotal TRILUMINATE study examining edge-to-edge repair technique using TriClip, which was published in The Lancet in November 2019. The study demonstrated that TriClip reduced severity of TR and was associated with strong improvement in functional capacity and in quality of life at six months.
TriClip builds upon the proven success of Abbott’s MitraClip device, which treats people with leaky mitral valves, or mitral regurgitation (MR). TriClip leverages the same clip-based technology as MitraClip but has a differentiated delivery system designed specifically for delivery to the tricuspid valve. A new, steerable guiding catheter system adapts to the right side of the heart, where the tricuspid valve resides, enabling the physician to effectively grasp and clip the leaflets of the tricuspid valve. Additionally, the TriClip device is available in two different sizes (NT and XT) to accommodate different patient anatomies.
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Breast biopsy system with real-time imaging

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The Brevera breast biopsy system with CorLumina imaging technology combines tissue acquisition, real-time imaging, verification and advanced tissue handling for an optimal patient and physician experience. Before this innovation, radiologists performing stereotactic breast biopsy procedures to diagnose breast cancer were often required to leave the patient under compression while they moved to another room to image and verify tissue samples. This leads to lengthy procedure times and anxious, uncomfortable patients, and can interrupt facility screening schedules. With the Brevera system, radiologists are able to obtain and image tissue samples in the procedure room in just a few seconds, potentially saving up to 10 minutes per patient and cutting the procedure time by up to 25 percent according to the 2015 Kadence International survey of 200 healthcare professionals. In addition to saving facility resources and clinician time during a breast biopsy procedure, the Brevera system’s proprietary CorLumina imaging technology helps enhance workflow across multiple departments within a health system. The technology automates the tissue sample collection and separation process, which allows patient tissue to be sent to pathology with little or no manual handling, and also protects the integrity of samples. The system also features PACS integration for advanced image sharing and transfer of patient records.

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Optional metal artifact reduction software for OnSight 3D extremity system

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Carestream Health has introduced a new optional advanced metal artifact reduction software for its OnSight 3D Extremity System which captures high-quality, low-dose 3D extremity exams. This second generation of software provides enhanced flexibility depending on the metal content present and reduces the visual distortion caused by screws, implants, rods and other metal objects to create improved visibility. Image processing can be adjusted and optimized according to the amount of metal present. The software uses information from the original scan to eliminate the need for additional imaging studies, which reduces costs and lowers radiation exposure for patients. An intuitive touch screen interface allows technologists to adjust for either moderate or complex metal content. The metal artifact reduction software can be activated prior to the scan or it can be applied after the original reconstruction is complete. Both the original and corrected images are always available to view and compare. The OnSight 3D Extremity System also assists surgeons in detecting occult and non-union bone fractures. Unlike traditional CT systems, this cone beam CT system has a large-area detector that captures a 3D image of the extremity in a single rotation, which takes only 25 seconds. A patient simply places the injured extremity into a donut-shaped opening in the system. Since the patient’s head and body are not confined, patients do not experience the claustrophobia that often occurs with traditional CT systems. Dose is significantly reduced because only the affected body part is imaged. The compact extremity system can be installed in an exam room and plugs into a standard wall outlet.
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Point-of-care blood gas system

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Siemens Healthineers recently announced the new RAPIDPoint 500e blood gas system, their latest solution in critical point-of-care testing. The new system generates blood gas, electrolyte and metabolyte results used to diagnose and monitor critically ill patients typically in the intensive care unit, operating room or emergency room. The RAPIDPoint 500e blood gas system is available now in all countries requiring the CE mark. Developed with extensive customer feedback, the system is designed to elevate confidence in patient results with Integri-sense technology, streamline workflow with improved simplicity and raise the bar in data security. Cybersecurity is becoming a key operational factor. Healthcare providers must protect confidential operator and patient information.
The RAPIDPoint 500e blood gas system incorporates Integri-sense technology, a comprehensive series of automated functional checks designed to deliver accurate test results at the point-of-care. Integri-sense technology combines three levels of automatic quality control (AutomaticQC), multiple calibration routines and advanced software algorithms to generate reliable and clinically actionable test results. It also integrates seamlessly into hospital networks with the Siemens Healthineers Point of Care Ecosystem which offers convenient, remote management of operators and devices located across multiple sites.

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POC hematology analyser successfully evaluated

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Two studies have been published that successfully evaluate the use of its Yumizen H500 hematology analyser for point-of-care testing (POCT) to enhance the care of oncology patients. With near-patient, full blood count results, patients undergoing chemotherapy can receive treatment without delay and greatly reduce their hospital/clinic exposure times. Both UK-based studies were presented at the recent ISLH 2018 (International Symposium on Technical Innovations in Laboratory Hematology) in Brussels.
The evaluation studies were performed by the Cardiff and Vale Health Board (CAVHB), University Hospital of Wales [1] and the Spire Bushey Laboratory, London [2] and can be viewed on the HORIBA Medical global website. Both studies demonstrated that the compact, easy-to-use analyser delivered at the POC clinically key parameters that showed exceptional correlation with larger laboratory-based hematology analysers. Blood samples from oncology patients may be abnormal, having low counts and atypical blood cells, therefore it is essential that near-patient testing does not compromise the clinical integrity of results.
The studies both found that in addition to speed and ease of use, the Yumizen H500’s functionality and audit systems fully adhere to ISO standards (both 15189:2012 and 22870:2016) with the same internal quality controls as larger analysers. This in turn ensured detailed, accurate results for timely and sound clinical decision making.
For example, the Cardiff study concluded that by using the Yumizen H500, “In CAVHB the potential for clinical improvement is potentially vast, average TAT (vein to report) for FBC is ~4 hours, this could be reduced to <15 minutes. This would mean that in certain patient groups (thrombocytopenic and anemic) they can request blood components earlier and be transfused more quickly, this in turn would reduce hospital stays. In neutropenic patients their treatment options could be considered more readily and reduce hospital/clinic exposure time in those that would not be appropriate for chemotherapy.”  With just three reagents and an intuitive touch screen user interface, HORIBA Medical’s Yumizen H500 compact hematology analyser is designed for ease of use; yet it offers a range of clinically key parameters, including: 5-population WBC differential, red blood cell parameters and platelet count. This makes the Yumizen H500 most suitable for rapid blood counting for use in POC settings for pediatric care and chemotherapy patients, as well as from emergency care to the routine laboratory.
The two POCT studies presented at ISLH 2018 can be viewed at:
https://www.horiba.com/en_en/products/by-segment/medical/

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Patient-controlled mammography system

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Senographe Pristina features an option to use a first-in-industry patient-assisted compression remote control to enable the patient, with the help of a technologist, to set the compression that feels right for her.
The handheld wireless remote control, called Pristina Dueta, allows patients to adjust the compression force after breast positioning. The technologist then guides the patient while she operates the remote control to adjust compression until she reaches an adequate compression level. The design strives to minimize women’s perceived pain and discomfort by giving them an active role in the application of compression.
In a patient survey conducted with 160 patients in two sites in Europe, 4 out of 5 patients who received their mammogram on the Pristina coupled with Pristina Dueta found it improved the comfort of their exam. Pristina has other design enhancements to improve exam comfort. The gentle, rounded corners of the image receptor or “bucky”, where the woman places her breasts, helps reduce discomfort and anxiety. It is also thinner so there’s less hard metal pushing into the patients’ ribs. The design also changes the way the patient is standing: Instead of requiring patients to grab conventional handgrips, which may cause tensing of pectoral muscles and therefore make it harder for the technologist to acquire clear images, patients can instead lean comfortably on armrests and relax their muscles to simplify positioning, compression and image acquisition.
By improving patient comfort, technologists can focus on precise positioning, potentially making the exam easier and faster. Poor positioning is a leading cause of retakes, and the lack of proper positioning may decrease mammography sensitivity. Pristina also includes the latest in 3D digital mammography technology, also known as digital breast tomosynthesis, which delivers superior diagnostic accuracy at the same low dose as a 2D mammography exam – and the lowest patient dose of all FDA-approved 3D mammography systems.
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Medtronic’s MiniMed 780G closed loop system for Type 1 diabetes management receives CE Mark

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Medtronic received CE Marking of its MiniMed™ 780G system, a next generation closed loop insulin pump system for the treatment of type 1 diabetes in people age 7 to 80 years.Leveraging the company’s advanced SmartGuard™ algorithm, the system automates the delivery of both basal insulin and correction boluses every five minutes to help people with diabetes avoid highs and lows with greater ease.
The MiniMed 780G system enables the personalization of glucose goals with an adjustable target setting as low as 100 mg/dL (5.5 mmol/L) – lower than any other advanced hybrid closed loop system – and is designed to help stabilize blood sugar levels and further improve glucose control.
“We wanted to design a system that further simplifies diabetes management and adapts to people’s life with the goal of enhancing their experience in a seamless way,” said Sean Salmon, Executive Vice President and President of the Diabetes Group at Medtronic. “We know it can be challenging to have to calculate carbohydrate intake before every snack or meal on a daily basis to ensure the right amount of insulin is dosed. With this system, users will have an extra layer of coverage for those times they miscalculate their carbs or forget to pre-bolus with an algorithm that automatically corrects for high glucose when needed. We want to help people spend more time living their life and less time worrying about their diabetes management – we’re confident this system delivers on that important goal.”
In addition to the automated algorithm which includes technology from DreaMed Diabetes, the MiniMed 780G system is easy to use with little input from the user. With the addition of Bluetooth connectivity, the MiniMed 780G system will enable users and their care partners to see real-time glucose data and trends on compatible iOS and Android smartphones via apps. Additionally, healthcare providers will find that managing patients on the system is simple as there are only a few settings that need adjustment to enable optimal use of the technology.
The system is expected to begin shipping this Autumn in select countries in Europe. In the United States, the MiniMed 780G system is investigational use only and not approved for sale.
For more information, visit: www.medtronicdiabetes.com
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