6 medical device news stories to watch in 2019

Sandra Maddock, president &CEO of IMARC Research With new technology and groundbreaking medical device news making headlines every day, there has never been a more exciting time to be involved in clinical research. So much is changing so fast — faster than at any other time in the history of clinical research. At IMARC Research, we take pride in innovation. We’re constantly monitoring medical device trends and regulatory updates to determine how they might apply to the clinical research teams who enlist our oversight. We know this will be a transformational year, so we’re excited to kick off 2019 with a series that highlights the most important medical device trends you need to know. In this post, we’ll focus on the biggest medical device stories to watch this year, then take a closer look at each in upcoming blog posts. The biggest medical device news stories to watch The use of wearable devices in clinical trials More smart medical devices Medical devices to prevent and treat opioid addiction Stronger regulations in the FDA’s 510(k) program More post-market data collection Less invasive heart surgery 1. The use of wearable devices in clinical trials Globally, more than 325 million people own wearable, connected devices, and more than 2.5 billion own smartphones. The potential of these devices to assist with data collection in clinical trials is huge. Patient-generated data is faster to collect and respond to, allowing ...
Source: Mass Device - Category: Medical Devices Authors: Tags: Blog IMARC Source Type: news

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es DU Abstract Human t-cell lymphotropic virus type 1 (HTLV-1)-associated myelopathy (HAM) is a progressive neurological disease whose diagnosis is defined by clinical manifestations and seropositivity for HTLV-1 infection. Cognitive impairment (CI) is considered to occur after spinal impairment. A 51-year-old HTLV-1-infected man classified as an asymptomatic carrier presented difficulties in listening comprehension and executive memory. He was assessed for central auditory processing (CAP), cognition (event-related auditory evoked potential [P300]), and otoneurological functions (galvanic vestibular-evoked myogen...
Source: The American Journal of Tropical Medicine and Hygiene - Category: Tropical Medicine Authors: Tags: Am J Trop Med Hyg Source Type: research
This study aims, first, to validate a retrospectively-gated implementation of the DENSE method for assessing brain tissue pulsations as a physiological marker, and second, to use the acquired measurements to explore intracranial volume dynamics. We acquired repeated measurements of cerebral volumetric strain in 8 healthy subjects, and internally validated these measurements by comparing them to spinal CSF stroke volumes obtained in the same scan session.Peak volumetric strain was found to be highly repeatable between scan sessions. First/second measured peak volumetric strains were: (6.4 ± 1.7)x10−4/(6.7...
Source: NeuroImage - Category: Neuroscience Source Type: research
In this report we conclude normal inflammatory markers cannot be used as exclusion criteria for the disease. We also review the body of literature to summarise the key features of the condition to assist clinicians in its diagnosis.
Source: Journal of Clinical Neuroscience - Category: Neuroscience Source Type: research
Publication date: January 2020Source: The Annals of Thoracic Surgery, Volume 109, Issue 1Author(s): Naoki Tadokoro, Yosuke Inoue, Kenji Minatoya, Hitoshi MatsudaUtilization of the Gelweave Valsalva graft (Terumo Vascutek, Tokyo, Japan) for David-type valve-sparing aortic root replacement was still controversial because this prosthesis did not completely reproduce the native sinus of Valsalva. We focused on the morphology of pseudo-Valsalva sinus after the reimplantation procedure and evaluated our novel crimp plication stitch from the viewpoint of morphology of Valsalva sinus at midterm follow-up periods.
Source: The Annals of Thoracic Surgery - Category: Cardiovascular & Thoracic Surgery Source Type: research
This report describes a case in which both these anomalies coexisted in an infant who underwent a successful Ross-Konno operation.
Source: The Annals of Thoracic Surgery - Category: Cardiovascular & Thoracic Surgery Source Type: research
Publication date: January 2020Source: The Annals of Thoracic Surgery, Volume 109, Issue 1Author(s): Safak Alpat, Keir A. Forgie, Isabelle VonderMuhll, Darren H. FreedAortico-left ventricular tunnel is a rare congenital anomaly requiring surgical repair early in childhood. After corrective surgery, such patients are at risk of developing aortic insufficiency and aortic root dilatation. Herein, we describe a valve-sparing aortic root replacement 3 decades after the repair of aortico-left ventricular tunnel.
Source: The Annals of Thoracic Surgery - Category: Cardiovascular & Thoracic Surgery Source Type: research
We report a successful percutaneous closure of the aortic valve using an oversized Amplatzer patent foramen ovale multifenestrated device (St Jude Medical, Saint Paul, MN) to treat aortic regurgitation associated with dilated aortic annulus in a patient with a continuous-flow left ventricular assist device.
Source: The Annals of Thoracic Surgery - Category: Cardiovascular & Thoracic Surgery Source Type: research
We present a case of surgical treatment of TAVR-PVE in a 75-year-old patient. The success of the treatment is based on the reduction of the operative trauma and length of the procedure with the use of minimally invasive right-sided thoracotomy and the Perceval sutureless aortic valve prosthesis (LivaNova, London, United Kingdom).
Source: The Annals of Thoracic Surgery - Category: Cardiovascular & Thoracic Surgery Source Type: research
Publication date: January 2020Source: The Annals of Thoracic Surgery, Volume 109, Issue 1Author(s): Husam H. Balkhy, Hiroto KitaharaThis is the first human case of totally endoscopic robotic-assisted aortic valve replacement using a sutureless valve. The patient is a 76-year-old man with symptomatic severe aortic valve insufficiency. A 12-mm robotic camera port and 25-mm working port were placed in the second intercostal space, and two 8-mm arm ports in the first and the third intercostal space with femoro-femoral cardiopulmonary bypass. Aortotomy, leaflet resection, confirmation of intraannular valve position, and aortic ...
Source: The Annals of Thoracic Surgery - Category: Cardiovascular & Thoracic Surgery Source Type: research
Publication date: January 2020Source: The Annals of Thoracic Surgery, Volume 109, Issue 1Author(s): Akiko Tanaka, Zain Al-Rstum, Samuel D. Leonard, Bri’Ana D. Gardiner, Ibrahim Yazij, Harleen K. Sandhu, Charles C. Miller, Hazim J. Safi, Anthony L. EstreraBackgroundWe reviewed the efficacy of intraoperative intercostal nerve cryoanalgesia for pain control in patients undergoing descending and thoracoabdominal aortic aneurysm repairs.MethodsDuring 2013 and 2017, 241 patients underwent descending and thoracoabdominal aortic aneurysm repair. Of those, 38 patients were treated with intraoperative cryoanalgesia to the inte...
Source: The Annals of Thoracic Surgery - Category: Cardiovascular & Thoracic Surgery Source Type: research
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