CompuFlo Epidural Anesthesia System Measures Pressure at Needle’s Tip, Cleared by FDA

CompuFlo Epidural Anesthesia System Measures Pressure at Needle’s Tip, Cleared by FDA

Milestone Scientific, Inc., a company out of Livingston, New Jersey, achieved FDA clearance for its CompuFlo Epidural Computer Controlled Anesthesia System. Milestone’s DPS Dynamic Pressure Sensing Technology is able to provide precise and continuous measurement of the pressure at the tip of the syringe, both helping to guide anesthesiologists when accessing the epidural space and recording the procedure for any post-op review. As the needle is advanced, the device provides both visual and audio feedback regarding the pressure levels being detected. Here’s a bit of detail about the study that has helped to result in the FDA clearance, according to Milestone Scientific: This clearance was supported by the COMPASS Study (CompuFlo® Assessment Study), which was a prospective, randomized, controlled, parallel group, multicenter, pivotal study to assess the safety and effectiveness of epidural space verification with the CompuFlo® Epidural Instrument. The primary objective of the COMPASS study was to determine whether the success rate of performance of lumbar epidural anesthesia with the CompuFlo Epidural to identify the epidural space is equivalent to performance of lumbar epidural anesthesia with the LOR technique. The clinical study enrolled 400 patients, of which two-hundred-forty subjects (240) required epidural procedure as part of the chronic pain management and one-hundred-sixty (160) required epidural procedure for acute pain management during labor and delivery. The CompuFlo® Epidural with Dynamic Pressure Sensing Technology resulted in the anesthesiologists objectively identifying the epidural space with 99% success on the first attempt. The COMPASS study involved use of the CompuFlo Epidural in 21 obese subjects (BMI > 31), with performance in this group found to be comparable to the performance seen in patients with lower BMIs....

Deep Learning Algorithm Diagnoses Schizophrenia from fMRI Scans

A scientific collaboration between researchers at IBM and the University of Alberta in Canada has come up with a software tool that analyzes functional magnetic resonance imaging (fMRI) scans of patient brains and with 74% accuracy diagnoses schizophrenia. Moreover, the software’s algorithms were also able to reasonably estimate how bad the symptoms of the disease were in individual patients. The team used fMRI data from the Function Biomedical Informatics Research Network that contains a large number and variety of imaging scans of brains of different patients. The investigators took 95 scans from a collection of schizophrenia patients and used them as input to a deep learning algorithm that found correlations in the scans to develop an understanding of what schizophrenia looks like. They then ran the algorithm against a set of scans of patients with the disease and without, demonstrating that the software is able to spot three quarters of the scans showing the disease. The team published their findings in journal Schizophrenia Research. Here’s a bit from the abstract: Whole-brain link-weight features achieved 74% accuracy in identifying patients and were more stable than voxel-wise node-degrees. Link-weight features predicted severity of several negative and positive symptom scales, including inattentiveness and bizarre behavior. The most-significant, stable and discriminative functional connectivity changes involved increased correlations between thalamus and primary motor/primary sensory cortex, and between precuneus (BA7) and thalamus, putamen, and Brodmann areas BA9 and BA44. Precuneus, along with BA6 and primary sensory cortex, was also involved in predicting severity of several symptoms. Overall, the proposed multi-step methodology may help identify more reliable multivariate patterns allowing for accurate prediction of schizophrenia and its symptoms...

New, More Effective Flu Vaccine Delivered Using Dissolvable Microneedle Patch

Researchers at Georgia State University have developed a more effective way of delivering influenza vaccines thanks to a dissolvable microneedle array and a special formulation of the vaccine. The microneedle device is made of a biocompatible polymer, the needles of which are tightly packed with the vaccine. The vaccine works well thanks to a novel fusion protein (4M2e-tFliC) that includes four versions of M2e, a peptide produced by the influenza virus. Each of the four versions come from different strains of the virus, making the protection broader than typical. But, to boost the immune system’s response to the vaccine, the fusion protein also has flagellin, a peptide that appears in most bacteria, that causes an alarm in the immune system and motivates it to engage more forcefully. In a laboratory study, the researchers showed that the new vaccine, via its delivery system that releases the vaccine into the dermis and epidermis, was able to achieve a more sustained and broader resistance to influenza in mice models. “Our study demonstrates that M2e-based vaccines greatly improve immune responses and strengthen protective functions against influenza virus infection,” said Wang, associate professor in the Institute for Biomedical Sciences at Georgia State. “We found that a skin-applied 4M2e-tFliC microneedle patch boosted immunization to seasonal vaccine recipients and may be a rapid approach to increasing the protective efficacy of seasonal vaccines in response to influenza virus challenges. Thus, the M2e antigen is a promising candidate for the development of universal influenza vaccines.” Some details from the study in Journal of Controlled Release: Compared with an intramuscular injection boost, mice receiving the MNP boost showed significantly enhanced...

New Way to Reprogram Macrophages Helps Immune System Kill Tumors

Macrophages, as their greek-derived name implies, are hungry white blood cells that consume all kinds of foreign and unwanted objects within the body. They are one of the primary methods that the immune system uses to fight off disease, and they work by checking the protein content on the exterior of cells to identify whether the cells are native or are invaders. In terms of cancer, macrophages, unlike T-cells, are able to penetrate solid tissue but are often a long way from being effective, ignoring diseased cells because the proteins on their outer layer match the ones found on healthy cells. At the University of Pennsylvania researchers have now come up with a strategy to modify macrophages so that they are able to spot cancerous cells. This may open a new front against solid tumors, as previously developed immunotherapy methods to fight cancer have been mostly effective against so-called “liquid” tumors that are hematologic in origin. The team modified the nature of macrophages to remove a mechanism that cancer cells use to pretend that they’re healthy. Specifically, they removed a protein on the surface of macrophages called SIRPA that interacts with a protein called CD47 that native cells use to tell the macrophages they’re on the same team. Since tumor cells exhibit the same CD47 protein in many cases, macrophages are fooled into ignoring them. In addition to the macrophages, the team also introduced antibodies via an injection that seek out tumor cells and help to alert the immune system. The combination of a warning mechanism by the antibodies and an ability to distinguish the cancerous cells by the macrophages made...

Embrace Neonatal MRI System Cleared to Stay Inside Neonatal ICUs

The FDA has just cleared Aspect Imaging‘s Embrace Neonatal MRI System, the first dedicated neonatal MRI system to receive a regulatory green light in the U.S. It’s intended to be used to image the head and brain, and to remain inside of neonatal intensive care units (NICU). Currently, these fragile little patients have to be moved to a distant MRI machine in the hospital, complicating the process and creating unneeded risks. Having the scanner nearby should help simplify imaging and being inside the NICU already can help address any emergencies that may arise. Because it’s a fully contained system, unlike traditional MRIs it does not require an exclusion zone nor is there a need to have additional walls shielding the radiofrequency signal. As such, MR Conditional and MR Safe implanted devices can be used by anyone in proximity to the scanner. Neonates with metal implants, on the other hand, are contraindicated from being imaged by the Embrace scanner. The Embrace features a temperature regulated incubator that moves in and out of the scanner with the baby inside. This helps to prevent the child from moving too much during scanning, while allowing clinicians to extricate the child out of the machine in less than 30 seconds if necessary. The device is indicated for neonates with a head circumference no larger than 38 centimeters and weight between 1 and 4.5 kilograms Here’s a promo video for the Embrace Neonatal MRI: Product page: Embrace Neonatal MRI System… Via:...