Filtered By:
Source: Mass Device
This page shows you your search results in order of relevance. This is page number 12.
Order by Relevance | Date
Total 467 results found since Jan 2013.
Study: Delaying thombectomy, even for minutes, can lead to lifelong consequences
Delaying endovascular thrombectomy treatment for patients with acute ischemic stroke can take time off of patient’s lives and cost hospitals extra, according to a new study reported by Medscape.
Results from the study were presented by Dr. Wolfgang Kunz of Munich, Germany’s Ludwig Maximilian University during the 11th World Stroke Congress.
Every hour of delay within the first six resulted in, on average, a loss of approximately 0.6 quality-adjusted life years, or approximately 7.7 months of disability-free life, according to the report.
Beyond patient outcomes, every hour of delay also reduces the economic value o...
Source: Mass Device - October 25, 2018 Category: Medical Devices Authors: Fink Densford Tags: Blood Management Clinical Trials Vascular Source Type: news
Nico raises $13m Series B for neurosurgery devices
Nico Corp. said today that it raised nearly $13 million in a Series B round from a group of existing backers for its line of neurosurgery devices.
Indianapolis-based Nico said the $12.5 million round is earmarked for new product development and commercialization, clinical and economic studies, growing its sales and clinical teams, and expanding its footprint in Europe.
“Our shareholders have again confirmed their commitment and confidence in the value and outcomes of Nico technologies and our ability to both grow and create new markets in neurosurgery,” president & CEO Jim Pearson said in prepared remarks....
Source: Mass Device - November 19, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Featured Funding Roundup Neurological Surgical Wall Street Beat Nico Corp. Source Type: news
Samsung ’ s NeuroLogica, MaxQ AI ink collab distro deal
Samsung Electronics (LON:BC94) subsidiary NeuroLogica said today that it inked a distribution deal with MaxQ AI to integrate its artificial intelligence software with NeuroLogica’s medical imaging tech in the U.S. and EU’s acute care marketplace.
Through the deal, NeuroLogica said that it will offer MaxQ’s Accipio IX, part of the AI-company’s FDA-cleared and CE Mark approved Accipio Insight intracranial hemorrhage platform intended to support acute care physicians by identifying patients with suspected intracranial hemorrhage using non-contrast head computed tomography imaging.
“We are honore...
Source: Mass Device - November 20, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Distribution Imaging Neurological Software / IT maxqai NeuroLogica Corp. samsung Source Type: news
Corindus asks FDA for expanded neurosurgery indication for CorPath GRX
Corindus Vascular Robotics (OTC:CVRS) said today that it submitted an application seeking FDA premarket clearance to use its CorPath GRX robotic surgical platform in neurovascular interventions.
The Waltham, Mass.-based company has already received FDA clearance for percutaneous coronary interventions, which it won in 2016, and for peripheral vascular interventions, which it won last year.
“The ability to treat neurovascular disease with CorPath GRX is the first step for physicians to gain critical experience with robotics. Applying the benefits of robotic precision to neurovascular intervention, while building a w...
Source: Mass Device - February 14, 2019 Category: Medical Devices Authors: Fink Densford Tags: Featured Food & Drug Administration (FDA) Neurological Regulatory/Compliance Robotics Surgical Corindus Vascular Robotics Source Type: news
TAVI: Claret Medical launches U.S. trial
Claret Medical launches a pivotal U.S. trial for its Sentinel cerebral protection system, which is designed to guard against stroke during transcatheter aortic valve implantation.
Claret Medical said today that the 1st patient has been treated in a U.S. pivotal trial of its Sentinel cerebral protection system, which is designed to guard against stroke during transcatheter aortic valve implantation.
Claret Medical Inc.News Well, Clinical Trials, Replacement Heart Valvesread more
Source: Mass Device - October 6, 2014 Category: Medical Equipment Authors: Alexander Soule Source Type: news
3rd FDA panel barely favors BSX's Watchman | Regulatory news for the week of October 13, 2014
Here's a look at some of the top regulatory stories for medical device companies this week: 3rd FDA panel vote barely favors Boston Scientific's Watchman anti-stroke device; Medtronic launches Verify incontinence device in the U.S.; FDA OKs Integra Lifesciences Puerto Rico plant; FDA approves Bard's Lutonix DEB
UPDATE: 3rd FDA panel vote barely favors Boston Scientific's Watchman anti-stroke device
October 9, 2014 by Brad Perriello
Boston Scientific, C.R. Bard, Food & Drug Administration (FDA), Integra LifeSciences Corp., MedtronicNews Well, Regulatory/Complianceread more
Source: Mass Device - October 14, 2014 Category: Medical Equipment Authors: MassDevice Source Type: news
Infraredx study: NIRS may help assess cardiac risk
Infraredx touts a study in the Journal of the American College of Cardiology showing its coronary imaging technology could help cardiologists assess a patient's risk for suffering a heart attack or stroke.
Infraredx touted a study in the Journal of the American College of Cardiology showing its imaging technology could help cardiologists assess a patient's risk for suffering a heart attack or stroke.
InfraReDx Inc., Journal of the American College of CardiologyNews Well, Clinical Trials, Cardiovascular, Imagingread more
Source: Mass Device - December 16, 2014 Category: Medical Equipment Authors: Val Kennedy Source Type: news
AHA, Medtronic team up to reduce recurrent strokes
Medtronic will work with the American Heart Association/American Stroke Association to reduce repeat strokes for which a cause isn’t known.
Medtronic (NYSE:MDT) and the American Heart Association/American Stroke Association will ally on a project focused on reducing repeat strokes for which a cause isn’t known.
Medtronic, American Heart Assn.News Well, Strokeread more
Source: Mass Device - February 18, 2015 Category: Medical Equipment Authors: Mark Hollmer Source Type: news
Boston Scientific's Mahoney is bullish on Watchman
Boston Scientific CEO Mike Mahoney is bullish on the company's Watchman anti-stroke device, saying he wants to double the number of hospitals offering the treatment beginning in the 3rd quarter.
Boston ScientificNews Well, Stroke, Wall Street Beatread more
Source: Mass Device - April 29, 2015 Category: Medical Equipment Authors: MassDevice Source Type: news
UPDATE: Baxter recalls Vascu-Guard patches in FDA Class I recall
UPDATED June 5, 2015, with details from the FDA.
Baxter (NYSE:BAX) said this week that it’s recalling its Vascu-Guard peripheral vascular patches packaged under 4 specific product codes. The company began notifying customers May 2.
The FDA has labeled it as a Class I recall, the most serious type of recall issued by the federal watch dog, which indicates that “there is a reasonable probability that use of these products will cause serious adverse health consequences or death.”
Deerfield Park, Ill.-based Baxter said it received complaints over the patches from customers who were unable to disting...
Source: Mass Device - June 4, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Food & Drug Administration (FDA) Recalls Vascular Baxter International Source Type: news
HeartWare completes enrollment in Endurance2 HVAD trial
HeartWare International (NSDQ:HTWR) said today it completed enrollment of its Endurance 2 destination therapy trial of its HeartWare ventricular assist system.
The trial seeks to examine the rate of stroke in patients treated with HeartWare’s HVAD device as well as optimal blood pressure management, the company said.
Data from the 465-patient supplemental cohort trial will be used to support pre-market approval for the HeartWare HVAD as a destination therapy system intended for long term use, according to the Framingham, Mass.-based company.
The device is currently FDA approved for bridge-to-transplant applications....
Source: Mass Device - August 10, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Assist Devices Cardiac Implants Cardiovascular Clinical Trials Regulatory/Compliance Surgical HeartWare International Inc. Source Type: news
CerebroTech wins CE Mark for non-invasive brain monitor
Non-invasive brain monitor company Cerebrotech Medical Systems said it won CE Mark approval for its intracranial fluids monitor.
The technology, developed at the University of California at Berkeley, detects changes in electrical proprties of tissues as a result of small changes in fluid, according to the Pleasanton, Calif.-based company’s site.
“We are very pleased to receive this validation of our technology. With clearance to commercialize in Europe, the company is moving into the next stage of its mission to significantly improve the clinical pathway and standard of care for patients with brain injuries,” sai...
Source: Mass Device - August 28, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Diagnostics Imaging Regulatory/Compliance Cerebrotech Medical Systems Source Type: news
HeartStitch touts new PFO closure method
Structural heart focused HeartStitch said today its NobleStitch EL device was used to repair 3 patients with patent forman ovale heart defects in Astana, Kazakhstan.
A patent foramen ovale is a congenital heart disease in which hole in the heart that normally seals at birth remains open, and can lead to severe migraines, visual auras and stroke, the company said.
The procedures were performed by Dr. Michael Mullen and guided by Anthony Nobles at the National Research Cardiac Surgery Center in Astana, according to the company.
“We are gratified that our colleagues from abroad have brought this technology to Kazakhstan...
Source: Mass Device - September 11, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Implants Cardiovascular HeartStitch Source Type: news
MassDevice.com +3 | The top 3 medtech stories for September 17, 2015
Say hello to MassDevice +3, a bite-sized view of the top three medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 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.
3. Battelle unveils new WayFinder hospital dashboard
Battelle said today it launched its WayFinder QI Dashboard advanced analytics tool designed to track and analyze internal data and metrics.
The Wayfinder uses statistical models to analyze pools of patient data data from hospitals and health sy...
Source: Mass Device - September 17, 2015 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 3 Source Type: news
Thoratec HeartMate 3 CE trial meets primary endpoint
Thoratec (NSDQ:THOR) said today the CE Mark trial of its HeartMate 3 left ventricular assist device has met its primary endpoint and reported a 92% rate of survival at 6 months. Data from the trial was presented at the Heart Failure Society of America’s annual meeting in Washington D.C.
The HeartMate 3 is a centrifugal-flow chronic left ventricular assist system which uses magnetically levitated technology and a reduced size for easier placement, the Pleasanton, Calif.-company said.
“The CE Mark trial data represents a very positive initial experience with HeartMate 3, including high survival rates, material i...
Source: Mass Device - September 28, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Assist Devices Cardiac Implants Cardiovascular Clinical Trials Thoratec Corp. Source Type: news
