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Total 11 results found since Jan 2013.
Korean JLK Inspection launches AI-powered imaging diag system
Korean JLK Inspection said yesterday that it launched its AIHub artificial intelligence-powered medical image diagnostics platform.
The newly launched AIHub system is designed to analyze images from a number of different imaging modalities, including magnetic resonance imaging, computed tomography, X-ray and mammography, the Seoul-based company said.
JLK Inspection claims the system can detect and monitor for more than 30 medical conditions in 14 regions of the body. The company added that the system is focused on brain diseases and conditions including ischemic stroke, hemorrhagic stroke, brain aneurysm and Alzheimer̵...
Source: Mass Device - December 27, 2018 Category: Medical Devices Authors: Fink Densford Tags: Diagnostics Imaging Software / IT jlkinspection Source Type: news
Neural Analytics launches study of transcranial doppler for evaluating mild-TBI
Neural Analytics said today it enrolled the 1st patient in a 2-year study exploring the use of its Lucid M1 transcranial doppler ultrasound system to evaluate cerebral blood flow in patients with mild traumatic brain injuries.
The Lucid M1 system is a portable all-in-one ultrasound system designed for measuring and displaying cerebral blood flow velocities in patients with brain disorders, the Los Angeles, Calif.-based company said.
In the 240-patient trial, researchers at the University of California Los Angeles will examine high school and college age enrollees in 3 separate groups, including those who have been affected...
Source: Mass Device - August 10, 2017 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Diagnostics Neurological Neural Analytics Source Type: news
UPDATE: Aspect Imaging wins FDA 510(k) for Embrace neonatal MRI
Updated to include comment from Aspect Imaging
The FDA today granted 510(k) clearance to Aspect Imaging‘s Embrace Neonatal magnetic resonance imaging device, which it touted as the 1st MRI device specifically designed for neonatal brain and head imaging.
The Embrace Neonatal MRI system is designed specifically for imaging neonatal heads, and can be used on nenonates with a head circumference of up to 38 cm and a weight between 1 and 4.5 kg, according to an FDA release. The system includes a temperature-controlled incubator which can be placed directly into the MRI system to reduce movement.
“The vision of Aspec...
Source: Mass Device - July 27, 2017 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Food & Drug Administration (FDA) Imaging Regulatory/Compliance Aspect Imaging Source Type: news
Aspect Imaging wins FDA 510(k) for Embrace neonatal MRI
The FDA today granted 510(k) clearance to Aspect Imaging‘s Embrace Neonatal magnetic resonance imaging device, which it touted as the 1st MRI device specifically designed for neonatal brain and head imaging.
The Embrace Neonatal MRI system is designed specifically for imaging neonatal heads, and can be used on nenonates with a head circumference of up to 38 cm and a weight between 1 and 4.5 kg, according to an FDA release. The system includes a temperature-controlled incubator which can be placed directly into the MRI system to reduce movement.
The system allows for urgent access to the neonates if necessary, with th...
Source: Mass Device - July 20, 2017 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Food & Drug Administration (FDA) Imaging Regulatory/Compliance Aspect Imaging Source Type: news
Siemens Healthineers inks deal with N.Y. provider Northwell Health
Siemens Healthineers (NYSE:SI) said today it inked a 4-year research deal with N.Y. state healthcare provider Northwell Health.
The 2 parties aim to develop research projects evaluating clinical effectiveness and outcomes using data analytics-based population health evidence. As part of the 4-year partnership deal, Siemens Healthineers will also provide full-time employees who will work jointly with Northwell Health.
“This partnership is first-of-its-kind for both Siemens Healthineers and Northwell Health to collaborate on research that could potentially define care pathways for various populations in the future. We...
Source: Mass Device - December 1, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Clinical Trials Research & Development Siemens Healthineers Source Type: news
MassDevice.com +5 | The top 5 medtech stories for November 14, 2016
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
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5. Final FDA rules clarify adverse event reporting for contract manufacturers
The FDA last week issued final guidance for medical device companies on the requirements for reporting adverse events that walked back much of the burde...
Source: Mass Device - November 14, 2016 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news
Study is 1st to quantify ‘ brain hacking ’ tDCS fields
Researchers have successfully visualized the field of effect of transcranial direct current stimulation using a novel magnetic resonance imaging technique, according to a new study.
Results from the study were published in the journal Nature last month.
Therapeutic procedures with tDCS are used to apply sustained changes in motor evoked potentials, and the technique has been shown to improve symptoms of neurologic and psychiatric disorders including epilepsy, Parkinson’s, depression, stroke and chronic pain.
The use of tDCS has even been shown to improve learning, modulate working memory and invoke other cognitive benefi...
Source: Mass Device - October 4, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Clinical Trials Neurological Neuromodulation/Neurostimulation Source Type: news
FDA clears icometrix ’ MRI quantification software
Health tech software developer icometrix said today it won FDA 510(k) clearance for its icobrain image quantification software.
The company’s icobrain software is designed to quantify key features of clinical magnetic resonance imaging brain scans to allow clinicians to monitor changes in their patient’s brains over time.
“MRI biomarkers are becoming of vital importance in the clinical care path for various pathologies including neurological disorders such as multiple sclerosis, traumatic brain injury and stroke. It is of paramount importance that the biomarker measurements are extremely reproducible and ...
Source: Mass Device - September 9, 2016 Category: Medical Equipment Authors: Fink Densford Tags: 510(k) Food & Drug Administration (FDA) Imaging Regulatory/Compliance Software / IT icometrix Source Type: news
Biotronik wins FDA nod for BioMonitor 2
Biotronik said today it won FDA premarket approval for its BioMonitor 2 magnetic resonance imaging-compatible insertable cardiac remote monitor.
The BioMonitor 2 device is designed for remote monitoring of patients with atrial fibrillation, syncope, bradycardia and tachychardia, Biotronik said. The device uses Biotronik’s ProMRI technology and is approved for full-body MRI scans at 1.5 and 3 tesla strength.
“Accurate diagnosis is the first step towards saving and improving patient lives. Too many patients suffer from undiagnosed heart conditions that lead to traumatic events including stroke and heart attack. BioMo...
Source: Mass Device - April 12, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Cardiovascular Food & Drug Administration (FDA) Pre-Market Approval (PMA) Regulatory/Compliance Biotronik Source Type: news
VasSol touts data on MRI-based blood flow measurement
VasSol said last week that results from a trial of its Nova non-invasive optimal vessel analysis showed that the device was able to identify critical trial patients at higher risk of recurrent stroke. The results from the study were published in the JAMA Neurology journal.
Results from the 6-year, multi-center Veritas trial indicated that patients who experience a stroke in the back of their brain, and continue to have reduced blood flow to the area, have a higher risk of having another stroke within 2 years.
“Nova is the only technology that can visualize and quantify the volume, speed and direction of blood flow...
Source: Mass Device - January 20, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Blood Management Clinical Trials Diagnostics Software / IT VasSol Source Type: news
TCT 2015: Thrombectomy no benefit in Medtronic’s Export studies
Thrombus aspiration in heart attack patients showed no benefit and raised the risk of stroke, according to a pair of studies of percutaneous coronary interventions using Medtronic‘s (NYSE:MDT) Export aspiration catheter, presented today at the annual Transcatheter Cardiovascular Therapies conference in San Francisco.
Early thrombectomy’s promise Totaled?
The 10,064-patient Total study compared PCI alone and PCI with thrombectomy in ST-elevated myocardial infarctions within 12 hours of onset. The primary endpoint (a composite of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or class...
Source: Mass Device - October 13, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiovascular Clinical Trials Medtronic TCT 2015 Source Type: news
