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iCAD, a company based in Nashua, New Hampshire, won European CE Mark approval for its ProFound AI for 2D Mammography software system.

The product relies on a “high-functioning, deep learning” artificial intelligence algorithm to analyze 2D mammography scans and point out potential areas of concern. The software package provides “Certainty of Finding” and “Case Scores” for each instance of a suspect lesion that it identifies, helping radiologists better focus on what’s important while quickening and improving the quality of diagnosis.

The system works by noticing slight changes in soft tissue densities and spotting calcifications, and because the company is working on improving the quality of its algorithm, future updates are expected to further benefit physicians and patients.

“ProFound AI for 2D Mammography has the potential to assist radiologists in their interpretation of 2D mammography images, as we have seen with ProFound AI for Digital Breast Tomosynthesis,” said Axel Gräwingholt, MD, Radiologie am Theater, in Paderborn, Germany. “As breast cancer rates continue to rise, it is imperative for radiologists to find cancers sooner, when they may be more easily treated, with fewer callbacks and false positives, which can be inconvenient and stressful for patients.”

Product page: ProFound AI for 2D Mammography

Via: iCAD

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INSIGHTEC, an Israeli firm, and GE Healthcare have won FDA approval and the European CE mark for the Exablate Neuro with the SIGNA Premier MRI.

The Exablate Neuro, made by INSIGHTEC, delivers focused ultrasound into the brain as a treatment option for Parkinson’s, essential tremor, and neuropathic pain (the last indication appropriate only to Europe). This gives clinicians the ability to treat patients without penetrating the scalp and brain.

The SIGNA Premier MRI, a 3.0 Tesla scanner from GE Healthcare, is used prior to the procedure to create an anatomical survey and prepare for treatment, and during treatment to monitor ultrasound delivery by keeping track of the temperature around the target area.

“We’re excited to continue expanding MR-guided focused ultrasound offerings with Insightec,” said Baldev Ahluwalia, MR Beyond Segment General Manager at GE Healthcare. “Now with Exablate Neuro cleared on GE Healthcare’s most powerful wide-bore 3.0T, SIGNA Premier, we’re taking another step forward in our journey together to improve incisionless brain surgery and expand the applications of MRI scanners to help enhance clinical care.”

Flashbacks: INSIGHTEC’s Exablate Neuro MR-Guided Focused Ultrasound Now Approved with 1.5T Scanners; FDA Expands Indication for Insightec’s Uterine Fibroid System; Focused Ultrasound, Guided by MRI, to Treat Alzheimer’s; Exablate Neuro MRI-Guided Focused Ultrasound for Essential Tremor Now Available in U.S; First Alzheimer’s Patient Treated with Focused Ultrasound to Open Blood-Brain Barrier; MRI Guided Focused Ultrasound Shows Promise for Essential Tremor Treatment; Exablate Neuro MRI-Guided Focused Ultrasound: Cleared in EU for Neurological Disorders

Product pages: Exablate Neuro; SIGNA Premier MRI

Via: INSIGHTEC

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The development of new drugs is a long and tedious process. Chemists come up with new libraries of molecules which biologists test to see whether these generate some kind of cellular response. Promising agents become models for further chemical development, and the process continues repeatedly until promising candidates for animal trials are found.

Researchers at the Karlsruhe Institute of Technology in Germany have now developed a chip that allows scientists to perform chemical synthesis and immediately follow up by testing the resulting compounds on live cells. The technology is fast and can be automated. It also requires smaller amounts of chemical solvents, reactants, and cell suspensions.

The new capability should speed up a good portion of the drug development process, allowing for drugs to come to market earlier while lowering the cost required to invent new ones.

From the study abstract in Nature Communications:

The chemBIOS platform is compatible with both organic solvents required for synthesis and aqueous solutions necessary for biological screenings. We used the chemBIOS platform to perform 75 parallel, three-component reactions to synthesize a library of lipidoids, followed by characterization via MALDI-MS, on-chip formation of lipoplexes, and on-chip cell screening. The entire process from the library synthesis to cell screening takes only 3 days and about 1 mL of total solution, demonstrating the potential of the chemBIOS technology to increase efficiency and accelerate screening and drug development.

Study in Nature Communications: Marrying chemistry with biology by combining on-chip solution-based combinatorial synthesis and cellular screening

Image: Array of microdroplets with various reactants on the chemBIOS chip-based synthesis platform. (Credit: Maximilian Benz, KIT)

Via: Karlsruhe Institute of Technology

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Centerline Biomedical, a company based in Cleveland, Ohio, landed FDA clearance for its Intra-Operative Positioning System (IOPS). The product provides physicians with a radiation-free way to navigate through vasculature during minimally invasive procedures.

Currently, X-ray fluoroscopy is used to track where minimally invasive instruments are in a patient’s body. Danger results from ionizing radiation, but also from the low-resolution 2D grayscale images that clinicians have to work with. These can make it challenging to understand the location and position of instruments, often leading to long procedures, difficulty completing them, or outright disasters.

Clinicians using the IOPS system, the technology behind which was originally developed at Cleveland Clinic’s Heart and Vascular Institute, start with a CT scan of the patient. This is used by the system’s mapping algorithms to create a digital model of the relevant vasculature. An electromagnetic tracking system is attached to the operating table, and a tracking pad is stuck to the patient. The two work together to identify the exact position of the patient, allowing the system to know where inside the patient a catheter or guidewire is.

Clinicians get to use 3D rendered, color images of the patient anatomy and to track their tools as they move through the vessels. Reportedly, understanding what’s going on during a procedure, something that can require a good deal of mental interpretation, is easier and quicker with the IOPs than with current methods.

The result is radiation-free navigation while looking at an attractive, intuitive, and live visualization of the patient anatomy and all the tools within.

Here’s a glance at the technology:

Dr. Matthew Eagleton Describes IOPS Technology - YouTube

Product page: Intra-Operative Positioning System (IOPS)

Via: Centerline Biomedical

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The company received its FDA clearance in 2016 when it transformed the traditional urinary catheter into a smart sensing platform that helps to accurately monitor vital signs in real-time, such as urine output (UO) and intra-abdominal pressure (IAP). Traditional urinary catheters have issues draining urine from the bladder, causing inaccurate UO measurements. Using active drain line clearance, the Accuryn® Monitoring System automatically clears the drainage line as needed.

Hayward, California – July 15, 2019 – Potrero Medical has received CE mark in the European Union for its technology platform, the Accuryn® Monitoring System.

“Urine output monitoring is an important field that has stagnated for decades. Based on my personal experience using Accuryn® in our burn unit, I can say that this device establishes a new state of the art,” said Dr. Bruce Friedman, clinical care co-director of the Joseph M. Still Burn Center. “Accuryn® is able to eliminate the obstruction of urinary outflow that is ubiquitous in current urine drainage systems. Solving this problem significantly improves the accuracy and diagnostic value of urine output monitoring.”

The company is also developing an artificial intelligence platform that would analyze the clinical data to enable interventions hours before the standard of care. One of those interventions is focused on Acute Kidney Injury (AKI). 

Today, almost 50% of all ICU patients suffer from AKI, a devastating condition that is responsible for nearly 300,000 deaths a year in the U.S. alone.1,2

In the United Kingdom, the annual cost of AKI-related inpatient care is estimated at £1.02 billion, just over 1% of the NHS budget.3  However, clinical reports have demonstrated that intensive monitoring of urine output can improve the early detection of AKI and reduce the risk of death.4 “Because Accuryn® finally provides accurate measurement of the kidney’s performance through real-time urine output, it opens up many future opportunities to improve patient care, reduce complications, and save money. Physicians will be able to have more precise fluid management, immediate insight into end-organ response to fluid/diuretic challenges, and quickly identify impending disease patterns such as acute kidney injury and sepsis” explained Dr. Gregory Schears, Professor of Anesthesiology & Critical Care, Mayo Clinic.

“Our mission is to give physicians deeper, scientific knowledge of how these complex fluid systems work in the body, providing hours instead of minutes to respond and prevent life-threatening events. That has the potential to shift paradigms” commented Joe Urban, CEO of Potrero Medical. “We are excited to expand our commercial footprint and bring our technology to European hospitals.”

For more information visit https://potreromed.com/

  1. Case J, Khan S, Khalid R, Khan A. Epidemiology of Acute Kidney Injury in the Intensive Care Unit. Crit Care Res Pract. 2013. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3618922/
  2. JLewington AJ, Cerdá J, Mehta RL. Raising Awareness of Acute Kidney Injury: A Global Perspective of a Silent Killer. Kidney international. 2013;84(3):457-467. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3758780/pdf/nihms463902.pdf.
  3. Kerr M., Bedford M., Matthews B., O’Donoghue D. The economic impact of acute kidney injury in England. Nephrol Dial Transplant. 2014;29(7):1362–1368. https://www.ncbi.nlm.nih.gov/pubmed/24753459
  4. Jin K, Murugan R, Sileanu F et al. Intensive Monitoring of Urine Output Is Associated with Increased Detection of Acute Kidney Injury and Improved Outcomes. Chest Nov 2017;152(5): 972-979. Available at: https://www.sciencedirect.com/science/article/pii/S0012369217309339

About Potrero Medical

Potrero Medical is a predictive health company that is developing the next generation of smart sensors and artificial intelligence.

The Accuryn® Monitoring System transforms the traditional indwelling urinary catheter (IUC) into a next-generation diagnostic tool for precise, real-time measurement of intra-abdominal pressure (IAP), urine output (UO) and core body temperature to help guide care.  Currently, Potrero Medical is developing a predictive health platform to help medical teams better predict adverse outcomes in critical care settings. The Accuryn® Monitoring System is not cleared for prediction of disease states or clinical conditions.

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Researchers at Tufts University and the Chinese Academy of Sciences have developed a new lipid nanoparticle which can deliver CRISPR/Cas9 gene editing tools into organs with high efficiency, suggesting that the system is promising for clinical applications.

The CRISPR/Cas9 system is currently being investigated as a way to treat a variety of diseases with a genetic basis, including Duchenne muscular dystrophy, Huntington’s, and sickle cell disease. While the system has significant promise, there are some issues that need to be resolved before it can be used clinically. CRISPR/Cas9 is a large complex, and it is difficult to get it inside cell nuclei where it is needed for gene editing.

Scientists have tried a variety of delivery vehicles for CRISPR/Cas, which are intended to carry the gene editing tools to their location and help them enter the cell and nucleus. These have included viruses and various types of nanoparticle. However, to date, these have suffered from low efficiency, whereby very little of the delivered agent reaches the cells or organs where it is needed.

The team’s new nanoparticles consist of a synthetic lipid layer which is broken down once the nanoparticles enter a cell, releasing the contents of the particles. The particles include messenger RNA versions of the gene editing tools, which the targeted cell then translates into a protein by itself using its own cellular machinery, meaning that the bulky proteins do not need to be directly transported into the cell.  

The nanoparticles demonstrated over 90% efficiency in affecting gene expression in treated kidney cells. When the researchers tested them in mice, they were able to significantly reduce the expression of a gene called PCSK9, which is linked to cardiovascular disease and levels of cholesterol, suggesting that the technique could be useful in humans.

“The lipid nanoparticles are one of the most efficient CRISPR/Cas9 carriers we have seen,” said Ming Wang, a researcher involved in the study. “We can actually knock down PCSK9 expression in mice with 80 percent efficiency in the liver, suggesting a real promise for therapeutic applications.”

Study in Advanced Materials: Fast and Efficient CRISPR/Cas9 Genome Editing In Vivo Enabled by Bioreducible Lipid and Messenger RNA Nanoparticles

Via: Tufts

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Researchers from Ecole Polytechnique Fédérale de Lausanne in Switzerland have developed new nanoparticles for theranostic (therapeutic and diagnostic) applications. Their work describes the synthesis of these particles and demonstrates that by stimulating at a long, safe wavelength, the nanoparticles can cleave bonds that hold onto drugs and release them into the body. This is an exciting development for the field of nanomedicine, and may one day lead to improved detection and treatment of many diseases, including cancer.

Nanoparticles have been developed in the past for theranostic applications, but they tended to rely on UV light, which is potentially dangerous and does not penetrate far into the body. To overcome this, the researchers utilized a new class of nanoparticles, called “harmonic nanoparticles,” which are sensitive to UV as well as safer, longer wavelength light, such as red and near infrared.

The way the technology works is the near infrared light stimulates the harmonic nanoparticle, which produces light at shorter wavelengths. The shorter wavelength can then break photo-sensitive bonds, which keep drugs attached to the particle. When those bonds are broken, the drugs are released.

In a proof of concept study, the authors synthesized bismuth ferrite harmonic nanoparticles (BFO HNPs). The HNPs were stimulated with light at 790 nm wavelength, which resulted in a release of light at 395 nm. That light then caused at photosensitive bond to be cleaved, releasing a molecule from the nanoparticles. The team quantified nanoparticle release using ultrahigh-performance liquid chromatography-mass spectrometry (UHPLC-MS). They found that without near-infrared stimulation the drug was not released, but upon stimulation the drug was released over time, demonstrating the particle behaves as desired.

The authors state that “this work is an important step in the development of nanocarrier platforms allowing decoupled imaging in tissue depth and on-demand release of therapeutics.”

The publication in ACS Applied Materials and Interfaces: Two-photon triggered photorelease of caged compounds from multifunctional harmonic nanoparticles

Via: Ecole Polytechnique Fédérale de Lausanne

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Undergraduate researchers at John Hopkins University have developed a cryoablation probe for breast cancer, which uses carbon dioxide instead of argon, making it more affordable and accessible for use in low resource regions.  

Treatments for women with breast cancer are scarce in poorer places. In fact, survival rates can be as low as 12% for breast cancer patients in places such as The Gambia, compared with 90% in the United States. Treatments that are commonly used in wealthier countries, such as surgery or chemotherapy, are either too expensive or impractical in poorer and more remote regions, where women frequently have to travel long distances to find a regional hospital that can offer help.

There is a clear need for an inexpensive solution, which can be applied in local clinics in such regions. To address this, a group of undergraduate researchers set out to adapt an existing cancer treatment, cryotherapy, to make it more suitable for a low resource context. Cryoablation does not require a sterile surgical suite or anesthesia, meaning that it would be suitable for use in local clinics, but traditional cryoablation can be very expensive, often costing upward of $10,000 for one treatment. Moreover, it typically requires a source of argon gas, which is difficult to find in low-resource areas.

The John Hopkins researchers turned to a readily available and inexpensive gas to power their new cryoablation system. Carbon dioxide is widely available, as it is used in carbonated soft drinks and as a cheap way of keeping things frozen worldwide. “When we started the project, experts in the area told us it was impossible to ablate meaningful tissue volumes with carbon dioxide,” said Nicholas Durr, a researcher involved in the project. “This mindset may have come from both the momentum of the field and also from not thinking about the importance of driving down the cost of this treatment.”

The researchers tested their carbon dioxide-powered cryoablation device in rats with mammary tumors, and found that it could kill a minimum of 85% of the tumor tissue, suggesting that it has significant potential in treating human breast cancers. While these initial results are promising, the device will need to be optimized further before it can proceed to clinical use.

Here’s a short video the Hopkins team released:

Cancer Cryoablation Probe - YouTube

Study in PLoS ONE: Validation of a low-cost, carbon dioxide-based cryoablation system for percutaneous tumor ablation

Via: Johns Hopkins

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A two-year-old girl has received a deep brain stimulation (DBS) device to treat her dystonia. The condition, which results in painful random muscle movements, spasms, and the like, can lead to severe limitations on a child’s development and overall quality of life.

A team at the Evelina London Children’s Hospital worked together to develop the necessary anesthesia protocols and surgical procedure.

One of the issues that the team had to consider was that DBS systems are made for much larger patients, and so the device had to be positioned and the procedure implemented accordingly. Another is that the implanted electrodes will eventually shift in relation to where they are now as the child grows, so the team planned for that by making sure they can make future corrections relatively easily.

One major hope for all of this is that manufacturers of DBS devices will realize that there’s a large enough market for pediatric patients out there. This will hopefully spur them to develop new devices that are specifically designed for use in young children.

Here’s a video report from the BBC about this latest achievement:

Images credit: Evelina London

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Scientists at MIT have taken inspiration from cucumber tendrils, the helical offshoots that grab onto fences and anything else they can, to create artificial muscle-like fibers. The new fibers can quickly contract and expand, and can lift objects many times their weight. The hope is that these may one day find their way into medical devices to help power ailing hearts, to give arm and leg prostheses more strength and agility, and to restore injured muscle tissue.

Using a fiber-drawing technique, these mini muscles are created with different polymers, each with its own thermal expansion characteristics. As the fiber is slightly heated, one material can bend better than the other, and if they’re intertwined just right inside the fiber, the whole fiber bends and turns into a helix.

As the fiber goes from straight to highly wound, it creates a strong pull on the tip. What’s interesting is that slight changes in temperature produce differences in the strength of the pull, allowing for careful control of the force that the fiber generates. By tweaking how the fiber is stretched during manufacturing, one can also control how responsive it will be to different temperature changes. The researchers had their fibers go through tens of thousands of contractions and they remained viable and in great working condition after all that.

Here are a few videos of examples of the new “muscles” being put to work:

Study in Science: Strain-programmable fiber-based artificial muscle

Via: MIT

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