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Source: Mass Device
Management: Hospitals
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Total 94 results found since Jan 2013.
This visor-like device could be a defibrillator for stroke
[Image from Cerebrotech Medical Systems]A portable, visor-like device has shown potential for detecting emergent large-vessel occlusion with 92% accuracy in patients who may have had a stroke. The researchers suggest that the diagnostic device could be readily accessible to emergency personnel and in public spaces in the same way a defibrillator is available for treating heart attacks.
Researchers and clinical investigators Medical University of South Carolina (MUSC), Mount Sinai and the University of Tennessee Health Sciences Center reported that patients who had a large-vessel occlusion and used the device could be sent ...
Source: Mass Device - April 10, 2018 Category: Medical Devices Authors: Danielle Kirsh Tags: Diagnostics Hospital Care mHealth (Mobile Health) Research & Development Cerebrotech Medical Systems Medical University of South Carolina (MUSC) MedTech Mount Sinai Stroke University of Tennessee Health Sciences Center Source Type: news
MedyMatch looks to future of stroke detection with AI platform launch
Artificial intelligence healthcare startup MedyMatch Technology said late last month its AI platform designed to detect intracranial hemorrhage or brain bleeds is now available for research.
The development is a milestone for the company, but is only the 1st stop for the platform, CEO Gene Saragnese told MassDevice.com in an interview.
“What we’ve done at MedyMatch is develop not just an algorithm, but an AI platform which looks at the entire patient – that is to say, the full richness of 3D imaging plus other patient attributes – to allow us, firstly, to understand whether that person is hemorrhagic st...
Source: Mass Device - December 5, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Imaging Software / IT MedyMatch 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
Stryker wins expanded CE Mark for Trevo stent retriever
Stryker (NYSE:SYK) said today that it won an expanded CE Mark indication in the European Union for its Trevo thrombectomy device as a front-line treatment for acute ischemic stroke patients for up to 24 hours from symptom onset.
The expanded indication lifts the previously cleared treatment window by 18 hours, according to the Kalamazoo, Mich.-based company, and follows a similar move in February by the FDA.
“Along with the expanded indication in the U.S., this expanded indication for Trevo in Europe marks a significant milestone in the treatment of stroke patients who suffer from this disease,” neurovascular...
Source: Mass Device - May 7, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Neurological Regulatory/Compliance Stroke Stryker Source Type: news
Silk Road touts low stroke rate in 2 studies of Enroute TCAR system
Silk Road Medical yesterday released data from 2 studies of its Enroute transcarotid neuroprotection and stent system, including 1-year data from a pivotal trial of the device and an interim analysis of a post-approval study of the Enroute.
Data from the studies was presented last month at the 44th annual Veith Symposium in New York.
The Sunnyvale, Calif.-based company touts the Enroute system and stent as the 1st and only devices currently approved for transcarotid artery revascularization procedures by the FDA.
Silk Road presented data from the Roadster 1 pivotal trial of the TCAR system, which examined the use of ...
Source: Mass Device - December 13, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Clinical Trials Vascular Silk Road Medical Inc. Source Type: news
Stryker halts enrollment early in Trevo study on high probability of success
Stryker (NYSE:SYK) said today that it’s putting an early stop to enrollment in a clinical trial of its Trevo anti-stroke device after a review board decided there’s a high probability of success for the study.
Kalamazoo, Mich.-based Stryker paid $135 million for Concentric Medical and its Trevo clot retriever back in 2011. The device is designed to remove the blood clots that cause ischemic stroke. Stryker said it’s halting enrollment in the 500-patient Dawn trial after signing on just 200 patients after a scheduled review by the study’s independent Data Safety Monitoring Board.
The Dawn trial is c...
Source: Mass Device - March 8, 2017 Category: Medical Equipment Authors: Brad Perriello Tags: Clinical Trials Vascular Stroke Stryker Source Type: news
Boston Scientific touts 1-year stroke reduction results in Watchman non-valvular AF trial
Boston Scientific (NYSE:BSX) today released 1-year results from the Ewolution registry study of its Watchman left atrial appendage closure device, touting a high implant success rate and stroke reduction in patients with non-valvular atrial fibrillation patients.
Data was presented today at the Heart Rhythm Society’s 39th Annual Scientific Sessions in Chicago.
“We are pleased to see that these ‘real-world’ results reinforce the positive outcomes observed in our clinical trial program, despite the registry patients being older and sicker than those enrolled in our previous trials,” rhythm man...
Source: Mass Device - May 12, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Boston Scientific 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
SynCardia responds to FDA note warning of high rates of stroke, mortality risk with TAH-t C2 Driver
SynCardia Systems this week responded to an FDA notice warning about a higher mortality risk and stroke rate with the company’s Temporary Total Artificial Heart Companion 2 Driver System noted as part of a post-approval study of the device.
In its response, the Tucson, Ariz.-based company said that the FDA letter, which warned of risks associated with the next-gen C2 driver, was not a recall notice, and that hospitals should continue to use the C2 driver without restriction.
SynCardia also said that the C2 Driver had not been identified as the root cause of the issues, which included higher rates of mortality and cerebr...
Source: Mass Device - August 29, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Clinical Trials Food & Drug Administration (FDA) SynCardia Source Type: news
ACC 2019: Abbott touts reduced stroke, bleeding and pump-clotting in HeartMate 3 trial
Abbott (NYSE:ABT) yesterday presented data from a new trial of its HeartMate 3 left ventricular assist device, touting a reduced rate of strokes, pump-related blood clots and bleeding episodes at two years as compared with the previous generation HeartMate II.
Data in the trial was presented at the American College of Cardiology’s 68th Annual Scientific Session 2019 in New Orleans and published simultaneously in the New England Journal of Medicine, the Chicago-area medical device company said.
Abbott touted its HeartMate 3 as the first implantable mechanical pump using fully magnetic levitation technology, making it fri...
Source: Mass Device - March 18, 2019 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Featured Abbott Source Type: news
ACC 2019: Medtronic, Edwards low-risk TAVR trial data could pave way to new indications
Results from trials of both Medtronic‘s (NYSE:MDT) and Edwards Lifesciences‘ (NYSE:EW) transcatheter aortic valve replacement systems exploring their use in low-risk patients indicated that the devices were as safe as open surgery, paving the way for possible new indications for TAVR technology.
Data from the trials were presented over the weekend at the American College of Cardiology 68th Annual Scientific Session 2019 in New Orleans and simultaneously published in the New England Journal of Medicine.
Currently, TAVR devices are only approved by the FDA for treating severe aortic valve stenosis in patients at inte...
Source: Mass Device - March 18, 2019 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Featured Replacement Heart Valves Edwards Lifesciences Medtronic Source Type: news
Neuravi launches clinical trial of Embotrap stent retriever
Neuravi said today it enrolled the 1st patient in a clinical trial of its novel EmboTrap revascularization stent retriever device for treating acute ischemic stroke.
Data from the study will be submitted as part of Neuravi’s FDA premarket approval application, the Ireland-based company said.
“Working to improve clinical outcomes in stroke is central to Neuravi’s mission, and we are committed to investing in clinical research in order to deliver advanced technologies and new clinical tools to physicians. We are honored to be working with an esteemed group of global leaders in stroke treatment as part of the A...
Source: Mass Device - November 5, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Clinical Trials Surgical Vascular Neuravi Limited 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
Edwards Lifesciences touts intermediate-risk data for Sapien devices | ACC 2016
Data from a large trial of the Sapien line of replacement heart valves made by Edwards Lifesciences (NYSE:EW) are slated to be used to back bids for expanded indications in intermediate-risk patients.
Presented over the weekend at the American College of Cardiology’s annual meeting in Chicago, results from the Partner II trial involving the Sapien XT and Sapien 3 transcatheter aortic valve replacements compared the TAVR treatments with traditional open surgery in the intermediate-risk cohort (both of the Edwards valves are already approved in the U.S. for high-risk patients).
Sapien XT non-inferior to surgery at 2...
Source: Mass Device - April 4, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiovascular Clinical Trials Replacement Heart Valves American College of Cardiology Conference (ACC) Edwards Lifesciences Source Type: news
J & J ’ s Cerenovus launches Galaxy G3 mini embolic coil, touts Arise II Embotrap study data
Johnson & Johnson‘s (NYSE:JNJ) Cerenovus division this week announced the launch of its Galaxy G3 Mini embolic coil and released data from a study of its Embotrap device designed to remove clots from the brain following ischemic stroke.
The Galaxy G3 Mini coils are designed to be approximately 25% softer than the Galaxy G3 xsft coils, with an ultra-low coil profile and a primary wind diameter of 0.009 inches, which Cerenovus said is the lowest profile available in its Spectra line.
The newly launched coil is designed to have a random complex shape to make it comformable and enable the device to seek and fill open...
Source: Mass Device - January 26, 2018 Category: Medical Devices Authors: Fink Densford Tags: Blood Management Business/Financial News Catheters Clinical Trials Neurological Vascular cerenovus johnsonandjohnson Source Type: news
