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Total 48 results found since Jan 2013.

Appropriate Use Criteria of Left Atrial Appendage Closure Devices: Latest Evidences
Expert Rev Med Devices. 2023 May 1. doi: 10.1080/17434440.2023.2208748. Online ahead of print.ABSTRACTAtrial fibrillation is the most common arrythmia and it is linked to an increased risk of stroke. Even if anticoagulation therapy reduces the rate of stroke the benefits of this therapy have to been balanced with the increased risk of hemorrhagic event. Left atrial appendage closure is a valid alternative to long term anticoagulation in patients with atrial fibrillation and high hemorrhagic risk. Actually new devices with different features have been tested and introduced progressively in the clinical practice. Improvement...
Source: Expert Review of Medical Devices - May 2, 2023 Category: Medical Devices Authors: Fabrizio Guarracini Eleonora Bonvicini Alberto Preda Marta Martin Simone Muraglia Giulia Casagranda Marianna Mochen Alessio Coser Silvia Quintarelli Stefano Branzoli Roberto Bonmassari Massimiliano Marini Patrizio Mazzone Source Type: research

Sequentially applied myoelectrically controlled FES in a task-oriented approach and robotic therapy for the recovery of upper limb in post-stroke patients: A randomized controlled pilot study.
CONCLUSIONS: Preliminary findings indicate that a combination of MeCFES and robotic treatment may be more effective than standard care for recovery of the plegic arm in persons > 3 months after stroke. The mix of motor learning techniques may be important for successful rehabilitation of arm function. PMID: 33386831 [PubMed - as supplied by publisher]
Source: Technology and Health Care - December 25, 2020 Category: Medical Devices Authors: Perini G, Bertoni R, Thorsen R, Carpinella I, Lencioni T, Ferrarin M, Jonsdottir J Tags: Technol Health Care Source Type: research

Consider the Promises and Challenges of Medical Image Analyses Using Machine Learning
Medical imaging saves millions of lives each year, helping doctors detect and diagnose a wide range of diseases, from cancer and appendicitis to stroke and heart disease. Because non-invasive early disease detection saves so many lives, scientific investment continues to increase. Artifical intelligence (AI) has the potential to revolutionize the medical imaging industry by sifting through mountains of scans quickly and offering providers and patients with life-changing insights into a variety of diseases, injuries, and conditions that may be hard to detect without the supplemental technology. Images are the largest source...
Source: MDDI - June 2, 2020 Category: Medical Devices Authors: Partha S. Anbil and Michael T. Ricci Tags: Imaging Source Type: news

Neurologic Outcomes in a Two-Center Cohort of Neonatal and Pediatric Patients Supported on Extracorporeal Membrane Oxygenation
Contemporary studies of long-term outcomes in children supported on extracorporeal membrane oxygenation (ECMO) in the United States are limited. We enrolled 99 ECMO patients between July 2010 and June 2015 in a two-center prospective observational study that included neurologic and neuropsychologic evaluation at 6 and 12 months, using standardized outcome measures. Pre-ECMO, 20 (20%) had a pre-existing neurologic diagnosis, 40 (40%) had cardiac arrest, and 10 of 47 (21%) children with neuroimaging had acute abnormal findings. Of 50 children eligible for follow-up at 6 or 12 months, 40 (80%) returned for at least one visit....
Source: ASAIO Journal - December 22, 2019 Category: Medical Devices Tags: Pediatric Circulatory Support Source Type: research

What ’s the Big Deal about Data in Medtech?
Discussion, “Top 5 Things You Need to Know about the Implantable Internet of Things." Brian Chapman, partner and leader of ZS’s medtech practice of ZS, attributes today’s focus on data to the intersection of two important things: "A general recognition that understanding more and connecting actions with outcomes will provide feedback and understanding that will drive standards of care. This is not new, but as capabilities rise in data collection, aggregation, and synthesize rise, and coupled with machine learning, the promise of data in healthcare is becoming even more ...
Source: MDDI - December 20, 2019 Category: Medical Devices Authors: Daphne Allen Tags: Digital Health Source Type: news

Facebook Makes Its Healthcare Debut
Cristin Moran, CEO of Growth Science, said it best last week at MD&M Minneapolis when she said almost every industry is interested in healthcare. We've already seen Apple, Amazon, Microsoft, and Google make power moves in healthcare, so it should come as no surprise that Facebook has now made its healthcare debut. The social media giant announced this week that it is developing products and partnerships aimed at connecting people with healthcare resources, starting with a new Preventive Health tool for U.S. consumers. Facebook said it is working with U.S. health organizations to offer the new tool, which is...
Source: MDDI - October 30, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Digital Health Source Type: news

Forest Devices Is Crushing It This Year
Forest Devices added another feather to its cap at The MedTech Conference in Boston, MA where the startup won the MedTech Innovator 2019 Showcase and received a $350,000 grand prize award. Forest is developing AlphaStroke, the first device designed to detect a stroke in any environment. The portable device uses electroencephalogram monitoring and machine learning to diagnose large vessel occlusions and other stroke subtypes, enabling first responders to triage patients to proper stroke centers. In 2018, the Pittsburgh, PA-based company closed an oversubscribed see...
Source: MDDI - October 7, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news

Age Well with Smart HealthTech
America is going gray. According to U.S. Census data, in 2030 even the youngest Baby Boomers will have reached 65, and older Americans will make up 21 percent of the population. That’s up from 15 percent today. By 2060, nearly a quarter of Americans will be at least 65 and a half million will reach age 100. These changing demographics give urgency to the concept of “aging in place.” Nobody wants to lose their independence, but that’s the reality for many who are forced from their homes by cardiovascular disease, stroke, cancer, diabetes or other chron...
Source: MDDI - August 19, 2019 Category: Medical Devices Authors: Stephanie Van Ness Tags: Digital Health Source Type: news

Japan approves iSchemaView ’ s Rapid stroke imaging device
iSchemaView today announced that it received registration approval in Japan for its Rapid imaging platform. The company received registration approval through the Japanese Pharmaceutical Affairs Law and through a third party review by the Japanese Assn. for the Advancement of Medical Equipment for the Rapid imaging platform. Rapid is designed to give physicians a fast, fully automated and easy-to-interpret imaging system that can help doctors make clinical decisions about stroke. “Stroke remains the fourth most common cause of death in Japan, and as the population ages, stroke is likely to become an increasing health...
Source: Mass Device - July 8, 2019 Category: Medical Devices Authors: Danielle Kirsh Tags: Cardiovascular Hospital Care Imaging ischemaview Source Type: news

Published Study Supports MyoKardia ’s Wrist-Worn Biosensor
MyoKardia’s said data on its wrist-worn digital health device was published in an article titled, “Machine Learning Detection of Obstructive Hypertrophic Cardiomyopathy (oHCM) Using a Wearable Biosensor,” in the Nature Partner Journal, Digital Medicine. The South San Francisco-based company said results from an exploratory study provided encouraging evidence of the potential for a wrist-worn biosensor to screen for obstructive hypertrophic cardiomyopathy. The study demonstrated that continuous monitoring using a wrist-worn photoplethysmography (PPG) digital health devic...
Source: MDDI - June 24, 2019 Category: Medical Devices Authors: MDDI Staff Tags: Business Cardiovascular Source Type: news

AI-Based Stroke Rehab System Shown to Be as Effective as One-on-One Therapy
The idea that the brain is capable of rewiring after a stroke is not new, but the therapy needed to achieve this is cumbersome at best. “Studies show that neuroplasticity requires hundreds to thousands of hours of repetition of focused, concentrated training to get the brain to have those functional changes,” said David Wu, Motus Nova’s CEO, in an interview with MD+DI. But he explained that those many hours of therapy with a clinician are not always feasible for patients, because of concerns about time and logistics, cost, and sometimes even a lack of motivation. So, Mo...
Source: MDDI - June 1, 2019 Category: Medical Devices Authors: Susan Shepard Tags: Digital Health Source Type: news

Learning to Walk Again
When someone suffers a stroke, he or she often loses some mobility, and some 60 percent of survivors are left with lower-limb deficits. “They usually have one leg that's more impaired than the other leg, and then they undergo rehabilitation and physical therapy. And often they don't fully recover,” said Conor Walsh, professor of engineering and applied sciences at the John A. Paulson Harvard School of Engineering and Applied Sciences and a core faculty member at the Wyss Institute for Biologically Inspired Engineering, in an interview with MD+DI. But a new device called ReSto...
Source: MDDI - April 17, 2019 Category: Medical Devices Authors: Susan Shepard Tags: Design Source Type: news

FDA Eyes Tailored Approach to Regulating AI-Based Medical Devices
FDA Commissioner Scott Gottlieb is making the most of his final week at the agency. In the month that has passed since Gottlieb rattled the medical device industry with news of his impending resignation, the commissioner has issued 18 public statements pertaining to nearly all corners of the agency's realm, from food, tobacco, and cosmetics to drugs and devices. Friday is Gottlieb's last day on the job. On Tuesday, Gottlieb said the agency will consider a new regulatory framework for reviewing medical devices that use advanced artificial intelligence algorithms. AI has been making headlines in medtech for a whi...
Source: MDDI - April 3, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Regulatory and Compliance Software Source Type: news

Using wearable devices in clinical trials
Brandy Chittester, chief of clinical operations, IMARC Globally, more than 325 million people own wearable, connected devices, and more than 2.5 billion own smartphones. Using wearable devices in clinical trials can bring huge benefits, however, there are also concerns. Here’s a look at how researchers are using wearable devices — and what you should consider before using them in your own research. How wearable devices are advancing medicine Right now, ClinicalTrials.gov, a global database of clinical trials, lists nearly 200 trials with “wearable devices” or “wearable technology” in the description. This in...
Source: Mass Device - March 12, 2019 Category: Medical Devices Authors: Danielle Kirsh Tags: Blog IMARC Source Type: news