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Source: Mass Device
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Total 467 results found since Jan 2013.
FDA warns on stents associated with stent-assisted neurovascular coiling procedures
The FDA today warned about risks associated with the use of neurovascular stents used in stent-assisted coiling procedures after receiving a number of reports that suggest possible associations between peri-procedural stroke or death with the use of the devices.
The federal watchdog warned of procedural risks or patient selection related health factors associated with the use of the neurovascular stents, including the use of such devices with patients who have serious co-morbidities which can result in reduced life expectancy, or patients who are intolerant to required anti-coagulant or anti-platelet therapy.
To avoid even...
Source: Mass Device - May 14, 2018 Category: Medical Devices Authors: Fink Densford Tags: Food & Drug Administration (FDA) Neurological Stents Vascular Source Type: news
HRS 2018: Device-related blood clots with Boston Scientific ’ s Watchman implant
Data from a study of device-related blood clots and the Watchman cardiac implant made by Boston Scientific (NYSE:BSX), presented today at the annual meeting of the Heart Rhythm Society in Boston, indicate the need for aggressive management of patients at risk for device-related thrombosis.
There were 74 incidences of DRT in 65 of the 1,739 Watchman patients examined in the study, or 3.7%; eight of those patients had multiple DRTs and two experienced embolic events (0.45%). There was no significant difference in mortality between patients with DRT and those without, according to the study.
Lead author Dr. Vivek Reddy, of N...
Source: Mass Device - May 11, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Cardiovascular Boston Scientific HRS 2018 Source Type: news
HRS 2018 Roundup: Device-related blood clots with Boston Scientific ’ s Watchman implant
Data from a study of device-related blood clots and the Watchman cardiac implant made by Boston Scientific (NYSE:BSX), presented today at the annual meeting of the Heart Rhythm Society in Boston, indicate the need for aggressive management of patients at risk for device-related thrombosis.
There were 74 incidences of DRT in 65 of the 1,739 Watchman patients examined in the study, or 3.7%; eight of those patients had multiple DRTs and two experienced embolic events (0.45%). There was no significant difference in mortality between patients with DRT and those without, according to the study.
Lead author Dr. Vivek Reddy, of N...
Source: Mass Device - May 11, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Cardiovascular Apple Bardy Diagnostics Boston Scientific Fitbit HRS 2018 Impulse Dynamics Imricor Medical Systems Inc. medicalgorithmics Medtronic Preventice samsung Source Type: news
HRS 2018: Study questions benefit of ablation over drug therapy for atrial fibrillation
Long-awaited data released today from a large clinical trial comparing catheter ablation with drug therapy in treating atrial fibrillation showed no significant benefit for ablation, according to Dr. Douglas Packer, who presented the findings today at the annual meeting of the Heart Rhythm Society in Boston.
The 2,204-patient trial, sponsored by the National Institutes of Health and industry players Medtronic (NYSE:MDT), Boston Scientific (NYSE:BSX), Abbott (NYSE:ABT) and Johnson & Johnson (NYSE:JNJ) unit BioSense Webster, focused on a primary composite endpoint of total mortality, disabling stroke, bleeding an...
Source: Mass Device - May 10, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Cardiovascular Wall Street Beat Cardiac Rhythm Management HRS 2018 Source Type: news
Penumbra shares rise on Q1 beat, growing sales
Shares in Penumbra (NYSE:PEN) rose today after the medical device maker topped expectations on Wall Street with its first quarter 2018 earnings results.
The Alameda, Calif.-based company posted profits of $5.5 million, or 15¢ per share, on sales of $102.7 million for the three months ended March 31, seeing a swing from the red on the bottom line while sales grew 40.3% compared with the same period during the previous year.
Earnings per share were well ahead of the 2¢ loss-per-share expectations on Wall Street, where analysts expected to see sales of $91.7 million, which the company also topped.
Penumbra lifted its sales...
Source: Mass Device - May 9, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News MassDevice Earnings Roundup Wall Street Beat Penumbra Inc. 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
Viz.ai wins FDA nod automated CT perfusion software
Artificial Intelligence healthcare developer Viz.ai said yesterday it won FDA 510(k) clearance for its Viz CTP computed tomography perfusion image processing and analysis software.
The San Francisco-based company said that the software compliments its current offerings, which include automated large vessel occlusion stroke identification, stroke triage and LVO notification, patient selection, medical image viewing, transport coordination and HIPAA-compliant communications..
“In stroke, good patient outcomes can come down to a matter of minutes. We are proud to offer hospital systems a comprehensive solution that ca...
Source: Mass Device - April 24, 2018 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Food & Drug Administration (FDA) Imaging Regulatory/Compliance Software / IT vizai Source Type: news
Emboline raises $10m Series B for TAVR embolism filter
Emboline said today that it pulled in a $10 million Series B round for the namesake embolic protector it’s developing for heart valve replacement procedures.
The Emboliner catheter is designed to prevent blood clots from passing into the cerebral vasculature during transcatheter aortic valve replacements. Santa Cruz, Calif.-based Emboline said the round includes $3 million from a consortium led by SV Tech Ventures and Shangbay Capital and $7 million in already-issued convertible notes. The cash is earmarked for Emboline’s SafePass clinical trial, submission for CE Mark approval and initial commercialization, ...
Source: Mass Device - April 19, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Funding Roundup Replacement Heart Valves Vascular Wall Street Beat Emboline Source Type: news
Bioelectronic Medicine: Targeting Inflammatory Disease with Electricity
We presented positive initial results in Crohn’s disease at the 2016 United European Gastroenterology meeting: six of the eight patients had seen a substantial reduction in their disease activity index scores, and three were in remission from the disease.
As SetPoint looks ahead, several chronic disease areas are emerging as key bioelectronic medicine therapy targets, and our company is exploring a number of these. One of our preclinical programs explores bioelectronic medicine’s potential role as a treatment for MS.
New Target: Multiple Sclerosis
In late 2017, SetPoint presented positive data from a study exp...
Source: Mass Device - April 17, 2018 Category: Medical Devices Authors: Anthony Arnold Tags: Bioelectronic Medicine Clinical Trials Neuromodulation/Neurostimulation SetPoint Medical Sponsored Content Source Type: news
Jan Medical begins coop BrainPulse testing with the US Army
Jan Medical said today that it has launched a cooperative research and development deal with the US Army Medical Materiel Agency to evaluate its BrainPulse device.
Jan Medical’s BrainPulse device is designed to non-invasively capture novel physiological signals through a patient’s cardiac output, used to measure vascular and brain tissue conditions, the company said. The data can be used as an ‘aid to diagnoses’ for multiple indications, including concussion and stroke.
Initial testing as part of the R&D program was completed on March 9, with the first user feedback session conducted today, the Mountain View, ...
Source: Mass Device - April 10, 2018 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Neurological Research & Development Jan Medical 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
Gore wins expanded indications for Cardioform septal occluder
W.L. Gore & Associates said today it won expanded FDA indications for its Cardioform septal occluder, now cleared for the closure of patent foramen ovale to reduce the risk of recurrent ischemic stroke in certain patients.
The expanded application was supported by results from the Reduce study, which the Newark, Del.-based company said showed that closure of PFOs could significantly prevent recurrent ischemic stroke regardless of PFO anatomy.
“With the FDA approval of the Gore Cardioform septal occluder for PFO closure, we can now provide physicians with one device that can be used for both ASDs and PFOs. The val...
Source: Mass Device - April 3, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance W.L. Gore & Associates Source Type: news
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 touts reduced AF, improved activity in AdaptivCRT studies
Medtronic (NYSE:MDT) today released results from two real-world analyses of its AdaptivCRT algorithm, touting that its use was linked to a reduction in atrial fibrillation episodes and higher patient activity levels.
Results from the analyses, which involved a total of 408 patients at 26 centers in Italy, were presented at the European Heart Rhythm Association’s Scientific Sessions 2018 in Barcelona, Spain, the company said.
Medtronic’s AdaptivCRT algorithm is designed to adjust pacing to the heart dependent upon evaluations of heart rhythm made every minute, the company said. The program has been shown to in...
Source: Mass Device - March 20, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Assist Devices Cardiac Implants Cardiovascular Clinical Trials Software / IT Medtronic Source Type: news
ACC ’ 18 Roundup: Abbott releases long-term HeartMate 3 data
Abbott (NYSE:ABT) touted two-year data yesterday from its trial designed to compare the company’s HeartMate 3 left ventricular assist device to its HeartMate 2 device in patients with advanced heart failure.
Data from the study were published in The New England Journal of Medicine and presented at the American College of Cardiology’s 67th Annual Scientific Session.
More than 1,000 patients participated in the study. Researchers assessed the trial’s participants for a short-term endpoint of six months and long-term endpoint of two years.
The two-year cohort met its primary endpoint, achieving 77.9% event...
Source: Mass Device - March 12, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Cardiac Assist Devices Cardiac Implants Cardiovascular Clinical Trials Diagnostics Food & Drug Administration (FDA) Regulatory/Compliance Research & Development Wall Street Beat Abbott Aetna AliveCor iRhythm Technologies Inc. Jan Source Type: news
