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Source: Mass Device
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Total 467 results found since Jan 2013.
Brainomix raises $10m for AI stroke imaging tech
Brainomix said today that it raised nearly $10 million for the e-ASPECTS stroke imaging technology it’s developing using artificial intelligence.
The £7 million round was led by Parkwalk Advisors, joined by existing backers Chimera Partners and Oxford University Innovation Fund and the venture arm of pharma giant Boehringer Ingelheim.
Oxford, England-based Brainomix said its tech is designed to automate the evaluation of stroke patients using CT scan data and the Alberta Stroke Program Early CT Score method. The funds are earmarked for commercializing e-ASPECT, the company said.
“We welcome Boehringer Ingelhe...
Source: Mass Device - April 3, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Diagnostics Funding Roundup Imaging Neurological Boehringer Ingelheim Pharmaceuticals Brainomix Stroke Source Type: news
Medtronic launches Arc stroke catheter in the U.S.
Medtronic (NYSE:MDT) said today that it expanded its thrombectomy offering in the U.S. with the Arc catheter, designed for use with its Solitaire stent retriever in treating acute ischemic stroke.
Fridley, Minn.-based Medtronic said the Arc catheter won 510(k) clearance from the FDA in July.
“The Arc support catheter will complement our Solitaire stent retriever and demonstrates our organization’s focus on the treatment of stroke,” neurovascular president Brett Wall said in prepared remarks. “The device also represents our organization’s ability to continue to deliver innovative technology.&...
Source: Mass Device - September 17, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Catheters Neurological Medtronic Stroke Source Type: news
FDA warns on SentreHeart’s Lariat anti-stroke device
The FDA today warned healthcare providers about the possibility of potentially deadly adverse effects from the Lariat anti-stroke device made by SentreHeart, saying a review of its adverse events database turned up 45 incidents involving Lariat, including 6 deaths.
The Lariat device is designed to close off the heart’s left atrial appendage, to prevent blood clots from forming there that could later cause stroke in patients with atrial fibrillation. The FDA said the reports from its Manufacturer & User Facility Device Experience database included complications from the Lariat procedures that included lacerati...
Source: Mass Device - July 13, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Regulatory/Compliance SentreHeart Stroke Source Type: news
Boston Scientific dips on Medicare reimbursement hit for Watchman anti-stroke device
Boston Scientific (NYSE:BSX) shares took a hit yesterday after a Centers for Medicare & Medicaid Services proposal that would limit coverage for the Watchman anti-stroke device. Investors also likely reacted to a pair of Class II recalls from the FDA, sending BSX shares down -4.2% to $18.01 apiece yesterday.
Watchman, a transcatheter implant designed to seal off the left atrial appendage to prevent the formation of blood clots that could cause stroke, was approved by the FDA in March and asked for a CMS coverage decision in May. The federal health insurer proposed to limit coverage for Watchman to patients in approv...
Source: Mass Device - November 12, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiac Implants Cardiovascular Recalls Boston Scientific Cardiac Rhythm Management Stroke Source Type: news
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
Perfuze raises $3m seed round for Millipede stroke catheter
Perfuze said today that it raised more than $3 million for the Millipede catheter it’s developing to treat ischemic stroke.
Although not quite in stealth mode, the Galway, Ireland-based firm is close-mouthed about its technology. CEO Wayne Allen and CTO Liam Mullins (who co-founded Embo Medical before its in 2015, $YY acquisition by C.R. Bard in 2015) founded Perfuze last year.
The €3 million ($3.4 million) seed round, earmarked for Millipede development, was led by European VC shop Earlybird. MedFocus, Enterprise Ireland and an Irish syndicate of medtech veterans and stroke physicians also participated, Pe...
Source: Mass Device - January 29, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Catheters Featured Funding Roundup Neurological Perfuze Stroke Source Type: news
Analysts: Worst case unlikely in Medicare call on Boston Scientific’s Watchman anti-stroke device
The worst-case Medicare reimbursement scenario for Boston Scientific‘s (NYSE:BSX) Watchman anti-stroke device is unlikely to play out, according to a pair of analysts.
Boston Scientific shares took a hit earlier this month after the Centers for Medicare & Medicaid Services proposed to limit coverage for the Watchman device, a transcatheter implant designed to seal off the left atrial appendage to prevent the formation of blood clots that could cause stroke. The FDA approved Watchman in March.
The federal health insurer proposed to limit coverage for Watchman to patients in approved clinical trials who can&#...
Source: Mass Device - November 23, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiac Implants Wall Street Beat Boston Scientific Centers for Medicare and Medicaid Services (CMS) Reimbursement Stroke 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.
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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
Boston Scientific halts EU sales of next-gen Watchman FLX anti-stroke device
Boston Scientific (NYSE:BSX) reportedly halted European sales of its the next generation of its anti-stroke device, the Watchman FLX, after receiving reports of device embolization.
Spokeswoman Trish Backes told TCTMD that there were 6 device embolizations in 207 (2.9%) European implantations of the Watchman FLX, an implant that designed to occlude the heart’s left atrial appendage. One of those patients died from complications related to an infection suffered after the device was retrieved.
The 1st-generation Watchman device showed a 30-day embolization rate of 0 to 0.7% in trials, and a post-approval registry calle...
Source: Mass Device - April 5, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiac Implants Cardiovascular American College of Cardiology Conference (ACC) Boston Scientific Stroke Source Type: news
Boston Scientific wins CE Mark for Watchman FLX anti-stroke implant
Boston Scientific (NYSE:BSX) said today that it won CE Mark approval in the European Union for the next iteration of its Watchman anti-stroke heart implant.
The Marlborough, Mass.-based medical device maker said the Watchman FLX is designed to be easier to implant during procedures to occlude the left atrial appendage and is re-capturable and re-positionable intraprocedurally.
Watchman FLX is under limited release in Europe, with more sites slated to come on line during the second half of the year, Boston Scientific said. A European post-market registry study is also planned, the company said.
“The Watchman device h...
Source: Mass Device - March 13, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Cardiac Implants Featured Wall Street Beat Boston Scientific Stroke Source Type: news
Studies support anti-stroke PFO closure devices from Abbott, Gore
Sykes and Clark; licensee BioMed Central Ltd.
A trio of studies published this week in the New England Journal of Medicine showed that devices from Abbott (NYSE:ABT) and W.L. Gore & Assoc. designed to close a heart defect lowered the risk of a recurring episode in certain cryptogenic stroke patients.
Long-term results from the 980-patient Respect trial of the Amplatzer device Abbott acquired along with St. Jude Medical this year, along with data from the Reduce study of Gore’s Helex and Cardioform and the French Close study of PFO closure devices with CE Mark approval, showed that they reduced the risk of recurr...
Source: Mass Device - September 15, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Cardiovascular Clinical Trials Surgical Abbott Structural heart W.L. Gore & Associates Source Type: news
Medtronic touts stroke data for HeartWare LVAD
A retrospective analysis of two studies involved the HeartWare left-ventricular assist device Medtronic (NYSE:MDT) acquired in 2016 showed that managing blood pressure reduced the severity of strokes in patients implanted with the HVAD pump.
The analysis, of “destination therapy” patients who are not candidates for a heart transplant, took data from the Endurance and Endurance Supplemental studies. Results were presented this week at the annual meeting of the International Society for Heart & Lung Transplantation in London, Medtronic said.
The 465-patient Endurance Supplemental study compared 308 patients i...
Source: Mass Device - April 5, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Cardiac Assist Devices Clinical Trials Featured Abbott HeartWare International Inc. Medtronic stjudemedical Thoratec Corp. Source Type: news
TCT 2017: Boston Scientific touts lowered hemorrhagic stroke rate, cost for patients in Watchman studies
Boston Scientific (NYSE:BSX) today released combined 5-year outcomes data from both the Prevail and Protect-AF study of its Watchman left atrial appendage closure device, touting it as a safe and effective an alternative to long-term warfarin therapy for patients with non-valvular atrial fibrillation.
Five-year data from the Prevail study was published online today in the Journal of the American College of Cardiology.
In both trials, the Marlborough, Mass.-based company compared the Watchman device to warfarin treatment for stroke prevention in patients with non-valvular AF with follow-ups out to five years. A combined an...
Source: Mass Device - November 2, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Boston Scientific Source Type: news
UPDATE: Medical societies update stroke guidelines
A bevy of cardiac medical societies updated their guidelines for stroke treatment yesterday to take into account new devices and technology, including left atrial appendage occlusion devices, stent retrievers and thrombectomy devices.
The American College of Cardiology, Heart Rhythm Society and Society for Cardiovascular Angiography and Interventions have updated their guidelines to include the benefits of left atrial appendage occlusion for patients with atrial fibrillation.
The groups suggests that the use of LAA occlusion devices, such as Medtronic‘s (NYSE:MDT) Watchman device, may lower the risk of stroke in se...
Source: Mass Device - June 30, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials American College of Cardiology American Heart Assn. Heart Rhythm Society Society for Cardiovascular Angiography & Intervention 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
