LivaNova’s Seizure Fighting Vagus Nerve Stimulators Approved for MRI

LivaNova’s Seizure Fighting Vagus Nerve Stimulators Approved for MRI

LivaNova, a company with offices in Texas and Belgium that makes vagus nerve stimulation (VNS) systems that help to prevent the onset of epileptic seizures, received FDA approval for patients with the implants to be free to undergo MRI scans. While some precautions are still necessary, the previous MRI related approval required special equipment to be used during scans that is rarely available. The new approval essentially means that patients should be able to safely receive MRI scans at any imaging facility, greatly expanding the diagnostic options for people that have a high chance of requiring imaging in the future. “The FDA’s approval to expand our MRI labeling changes the landscape for device-based epilepsy therapies,” in a statement said Jason Richey, LivaNova’s President of North America & General Manager of the Neuromodulation franchise. “This further differentiates our technology from other epilepsy treatment options and adds a new dimension in our ability to support patients’ long-term treatment plans.” Flashback: AspireHC Vagus Nerve Stimulator Cleared in U.S. Market… Link: LivaNova VNS Therapy info page… Via:...

Computer Vision Algorithm Studies Laparoscopic Procedures to Understand What’s Going On

Laparoscopic surgeries are often automatically recorded from the point of view of the endoscope’s lens. This is thanks to built-in recording equipment that accompanies many commercial endoscopic systems. What isn’t easy is reviewing all those hours of footage to find something that may be useful for training clinicians or that may be used to improve laparoscopy-related equipment. Now researchers at MIT have reported at the International Conference on Robotics and Automation in Singapore on a new video processing system that can, on its own, identify different stages of laparoscopic surgeries, potentially allowing researchers to quickly find relevant scenes that they can easily study. The computer vision algorithm powering the system can spot when a biopsy is performed, a wound irrigated, or tissue stapled, among other activities. Moreover, other actions can also be programmed into the system for it to find among recordings. While initially developed to analyze pre-recorded video, the same software may one day help surgeons intraoperatively, by recognizing what steps are being taken and warning when something doesn’t look normal. It may also help suggest when and which instruments to use and generally serve as an additional vigilant eye over the course of the procedure. “Surgeons are thrilled by all the features that our work enables,” in an MIT announcement said Daniela Rus, Professor of Electrical Engineering and Computer Science and senior author on the paper. “They are thrilled to have the surgical tapes automatically segmented and indexed, because now those tapes can be used for training. If we want to learn about phase two of a surgery, we know exactly where to go to look for that segment. We...

HxRefactored 2017 Day 1: Purpose Driven Design, Health Equity, and the Clinician Experience

Welcome to Medgadget‘s coverage of HxRefactored taking place this week in Cambridge, Massachusetts. Now in its seventh year, HxRefactored, a Health 2.o and Mad*Pow event collaboration, brings together healthcare designers, practitioners, and technologists to learn about and discuss opportunities to improve health experiences through human centered design and technology. Over the event’s couple of days, HxRefactored is bringing together a combination of keynote speakers and breakout sessions to dive into the creative intersection of healthcare and design thinking. Matthew Holt Earlier this morning, prior to the formal event kickoff, attendees had a chance to hit the ground running by participating in pre-conference workshops on topics such as Behavior Change Design for Healthy Aging and Discovering Unmet Needs and New Solutions through Participatory Design. Amy Cueva, Founder and CEO of Mad*Pow, and Matthew Holt, Co-Chairman of Health 2.0, launched HxRefactored from the main stage with a sampling of what attendees will be exposed to over the next couple days. Additionally, for all of those who missed the announcement, Matthew reminded attendees of Health 2.0’s recent acquisition by HIMSS while Amy spoke about Mad*Pow’s Center for Health Experience Design, which is currently in the process of onboarding new individual and organization members to the group. Amy Cueva With the scene set, Amy gave the first keynote of the event on purpose driven design. While human centered design is important and appropriate in the context of healthcare where the patient should be the center of clinical systems and workflows, Amy believes that, by itself, human centered design is insufficient to achieve better outcomes. Purpose driven design is also necessary as a complement to human centered strategies and...

Cloud Tech for Life Sciences Research: Interview with Kara Dennis, Managing Director of mHealth at Medidata Solutions

Medidata Solutions is a global provider of cloud-based technology and data analytics for clinical research. They work with a variety of life sciences clients who conduct studies to gather, store and analyze data to help assess the safety and efficacy of their products before bringing them to market. Amassing and securely storing the enormous amounts of data generated in clinical research can be challenging, as can handling and analyzing these datasets. Medidata aims to provide a platform to help streamline this process and overcome regulatory hurdles. One focus for the company is helping sponsors who are interested in leveraging wearable devices in their clinical R&D programs, which are becoming more popular. However, there are still some challenges to overcome before the trend is fully adopted. Medgadget had the opportunity to ask Medidata’s Managing Director of Mobile Health (mHealth), Kara Dennis, some questions about their business and how the organization is helping move clinical research forward through the use of wearable devices.   Conn Hastings, Medgadget: What is Medidata’s role in alleviating some of the frustrations that come with collecting large amounts of data from clinical research, particularly when it comes to wearables? Kara Dennis, Medidata Solutions: The heart of Medidata’s business is improving the way clinical research is designed, conducted and analyzed through integrated technologies and data analytics. The emergence of mobile health is enabling sponsors to capture a richer, more complete dataset directly from patients, gain unprecedented visibility into the patient journey, and provide researchers with a more objective, nuanced picture of a therapy’s safety and efficacy. However, working in mobile health often means ingesting large amounts of...

Newly Designed Nanorods Act as Dual Imaging Agents for Improved Diagnostics and Surgical Use

Scientists at the PNG College of Technology have developed new nanoscale rods that may be an effective dual-mode imaging agent for detecting cancer. The nanorods can be seen using both magnetic resonance and optical imaging techniques. Combining the two offers potentially better localization results during pre-op imaging, but can also allow for easy to use optical intraoperative identification of tumor tissue that was originally spotted using MRI. The nanorods are made of gadolinium oxide doped with the element europium. They are also coated in a layer of silica so that the potentially toxic material they’re made of doesn’t make direct contact with the body. The performed in vitro cytotoxicity study that showed low levels of toxicity at reasonable concentration levels. These are still early developments for this technology and the nanorods may be more finely tuned to create a more powerful signal. This would further reduce the required concentration levels, potentially one day leading their introduction into clinical practice. According to Dr. R. Arun Kumar, Associate Professor, PSG College of Technology, “The developed nano-contrast serves for both MRI and optical imaging. Therefore, the imaging of cancer with higher sensitivity and spatial resolution is possible. The mortality rate can also be reduced.” Study in journal Nano: Silica-Coated Europium-Doped Gadolinium Oxide Nanorods for Dual-Modal Imaging of Cancer Cells… Via: World Scientific...