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Total 21 results found since Jan 2013.
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
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
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
FDA clears software using AI to evaluate CT scans for stroke
Artificial Intelligence healthcare developer Viz.ai said this week it won approval from the FDA for its LVO Stroke platform designed to analyze computed tomography results and notify providers of potential strokes, touting it as the first such system to win FDA clearance.
The company’s LVO Stroke platform is designed using deep learning and connects to a hospital CT scanner to alert stroke specialists that a suspected LVO stroke has been identified, with the ability to send radiological images directly to the physician’s phones.
“Timely LVO stroke identification and transfer to a specialist hospital that ...
Source: Mass Device - February 16, 2018 Category: Medical Devices Authors: Fink Densford Tags: Food & Drug Administration (FDA) Regulatory/Compliance Software / IT vizai Source Type: news
FDA clears AliveCor ’ s KardiaBand ECG for Apple Watch
AliveCor said today that the FDA cleared its KardioBand electrocardiogram device for the Apple Watch, designed to monitor for early signs of atrial fibrillation.
First introduced in March 2016, KardiaBand is the first medical device accessory to be cleared by the federal safety watchdog for the Apple Watch, Mountain View, Calif.-based AliveCor said. It’s designed to display and record clinical-grade cardiac rhythm readings in real time in about 30 seconds, the company said.
AliveCor also said it launched the SmartRhythm artificial intelligence app for the Apple Watch, which is designed to continuously evaluate the ...
Source: Mass Device - November 30, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Patient Monitoring Wall Street Beat AliveCor Cardiac Rhythm Management Source Type: news
Edwards Lifesciences has ‘ key events ’ around TAVR this week
Edwards Lifesciences is planning some important TAVR reveals during the PCR London Valves 2017 course that is underway.
The Irvine, Calif.–based cardio devices company said yesterday that it plans to introduce the new Sapien 3 Ultra valve during the event, which runs until tomorrow.
Edwards officials expect the Sapien 3 Ultra to receive CE Mark by the end of the year, with plans for a U.S. introduction in late 2018. For the Ultra, they’ve added a taller skirt to the Sapien 3 design to improve TAVR outcomes, according to the company.
Edwards has incorporated the taller skirt initially with sizes 20, 23 and 26 mm. A...
Source: Mass Device - September 25, 2017 Category: Medical Devices Authors: Chris Newmarker Tags: Business/Financial News Cardiac Assist Devices Cardiac Implants Cardiovascular Catheters Clinical Trials Edwards Lifesciences tavr Source Type: news
MassDevice Q & A: Claret Medical ’ s Azin Parhizgar on trying to make TAVR safer
Cerebral protection developer Claret Medical recently won FDA de novo clearance for its Sentinel device designed to trap blood clots and prevent stroke during heart valve replacement procedures.
The Sentinel uses a pair of filters, 1 in the brachiocephalic artery another in the left common carotid artery, to trap debris released during transcatheter aortic valve replacement that could cause a cerebral embolism.
The device has seen a rough road to approval, however, after missing the primary efficacy endpoint in its pivotal trial. Despite that, the device saw nearly unanimous support from an FDA advisory panel and was c...
Source: Mass Device - June 12, 2017 Category: Medical Devices Authors: Fink Densford Tags: Neurological Surgical Vascular Claret Medical Inc. Source Type: news
7 medtech stories we missed this week: June 2, 2017
[Photo from unsplash.com]From Implandata receiving CE Marking to Inolife eyeing up-listing, here are 7 medtech stories we missed this week but thought were still worth mentioning.
1. Dextera seeks expanded indications for MicroCutter 5/80 stapler
Dextera Surgical announced in a June 1 press release that it has filed a 510(k) with the FDA for its MicroCutter 5/80 stapler. The company wants to expand the indications of the MicroCutter 5/80 for use in liver, pancreas, kidney and spleen surgeries. Currently, the staplers are used for transection and resection in multiple open minimally-invasive urologic, thoracic and pediatr...
Source: Mass Device - June 2, 2017 Category: Medical Devices Authors: Danielle Kirsh Tags: Business/Financial News Clinical Trials News Well Regulatory/Compliance Research & Development c2 Therapeutics Dextera Surgical DreaMed Diabetes EndoGastric Solutions Inc. Implandata Inolife MicroTransponder Inc. Source Type: news
Medical imaging AI dev Viz raises $8m in seed round
Medical imaging artificial intelligence company Viz said today it closed a $7.5 million seed round of financing to support the development of its AI platform.
Viz is developing an AI-equipped medical imaging platform with an initial focus on stroke, looking to improve outcomes and treatment of stroke patients by shortening the time between seeking and receiving treatment.
The company’s AI platform is being developed to compare patient scans to thousands of other scans to determine patterns within them, and aid in treatment accuracy and speed.
“As doctors, there is nothing more important to us than improving pat...
Source: Mass Device - May 25, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Imaging Software / IT viz Source Type: news
Artificial intelligence accurately predicts stroke risk
[Image from unsplash.com]Machine-learning algorithms, a form of artificial intelligence, accurately predicted people’s risk of heart disease and stroke, according to new research from the University of Nottingham.
Researchers and computer scientists compared the risk guidelines for heart disease and stroke from the American College of Cardiology with 4 machine-learning algorithms to analyze the risk of a patient having each. The results showed that the artificially intelligent algorithms were significantly more accurate at predicting cardiovascular disease than the regular medical models.
Get the full story on our sister...
Source: Mass Device - May 25, 2017 Category: Medical Devices Authors: Danielle Kirsh Tags: Cardiovascular Research & Development AI artificial intelligence cardiovascular disease heart disease machine learning algorithms Stroke University of Nottingham Source Type: news
Japanese automakers get in on health robotics
ReWalk Robotics
Japanese automakers, including Toyota (NSDQ:ADR), are reportedly turning their focus to robots to help the country’s rapidly aging society.
Japan faces dwindling demand for cars and its falling population has yielded labor shortages and pension squeezes. Toyota today launched a rental service for its walk assist system, which helps stroke survivors learn how to walk again.
Get the full story at our sister site, Medical Design & Outsourcing.
The post Japanese automakers get in on health robotics appeared first on MassDevice.
Source: Mass Device - April 12, 2017 Category: Medical Equipment Authors: Sarah Faulkner Tags: Robotics Toyota Source Type: news
4 Key Insights When Raising Money for Your Medtech Startup: Interview with Bruce Shook, CEO of Intact Vascular
Welcome to the Medsider interview series, a regular feature at MassDevice. All interviews are conducted by Scott Nelson, Founder of Medsider and Group Director for WCG. We hope you enjoy them!
Bruce Shook joined Intact Vascular in 2014 as President and CEO. A highly-experienced, medical device executive with more than 30 years of industry experience, Bruce was previously Co-founder, Director, President, and CEO of Neuronetics, which is a privately held medical device company that markets a non-invasive brain stimulation technology for the treatment of depression.
Previously, Shook was Co-founder, Director, President, an...
Source: Mass Device - February 27, 2017 Category: Medical Equipment Authors: Danielle Kirsh Tags: Blog medsider Source Type: news
Philips launches Intellispace Portal 9.0 radiological visual analysis & quantification platform
Royal Philips (NYSE:PHG) said today it launched its IntelliSpace Portal 9.0, the most recent iteration of its radiological visual analysis and quantification platform.
The new version of the platform utilizes machine learning to aid operating radiologists in detecting, diagnosing and following-up on treatment for diseases and traumas, such as brain juries and neurological disorders including dementia, stroke, amyotrophic lateral sclerosis and multiple sclerosis.
“As the rates of dementia and neurodegeneration rise, neuroradiologists need advanced tools to help referring physicians treat these challenging cases. Inte...
Source: Mass Device - November 29, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Imaging Software / IT Royal Philips 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
Event Cardio’s NowCardio remote cardiac monitor wins Health Canada OK
Heart monitoring system developer Event Cardio said today it won Health Canada approval for its NowCardio heart monitoring system, and will begin distribution in Canada this month.
The NowCardio device is a non-invasive, wireless continuous heart monitoring device which allows for Holter monitoring, automatic arrhythmia detection, patient triggered alarms and real-time streaming of all ECG data, the New York-based company said.
“After nearly 5 years of hard work and dedication, we have achieved a key milestone in our commercialization strategy for NowCardio with the issuance of this Health Canada medical device licen...
Source: Mass Device - July 6, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Cardiovascular Patient Monitoring Regulatory/Compliance Event Cardio Group Source Type: news
