Filtered By:
Source: Mass Device
This page shows you your search results in order of date. This is page number 18.
Order by Relevance | Date
Total 467 results found since Jan 2013.
Siemens Healthineers inks deal with N.Y. provider Northwell Health
Siemens Healthineers (NYSE:SI) said today it inked a 4-year research deal with N.Y. state healthcare provider Northwell Health.
The 2 parties aim to develop research projects evaluating clinical effectiveness and outcomes using data analytics-based population health evidence. As part of the 4-year partnership deal, Siemens Healthineers will also provide full-time employees who will work jointly with Northwell Health.
“This partnership is first-of-its-kind for both Siemens Healthineers and Northwell Health to collaborate on research that could potentially define care pathways for various populations in the future. We...
Source: Mass Device - December 1, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Clinical Trials Research & Development Siemens Healthineers Source Type: news
MassDevice.com +5 | The top 5 medtech stories for November 30, 2016
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 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.
Get this in your inbox everyday by subscribing to our newsletters.
5. Smart patch monitors blood, releases blood thinners to prevent clots
Researchers from the North Carolina State University and the University of North Carolina at Chapel Hill have developed a patch designed to monitor a patientâ...
Source: Mass Device - November 30, 2016 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news
Smart patch monitors blood, releases blood thinners to prevent clots
Researchers from the North Carolina State University and the University of North Carolina at Chapel Hill have developed a patch designed to monitor a patient’s blood and release blood-thinning drugs to prevent dangerous blood clots, or thrombosis. The team’s work was published in Advanced Materials.
When blood clots disrupt the flow of blood throughout the body, the result can cause pulmonary embolism, heart attack or stroke. Conventional treatment requires patients to regularly test their blood to ensure proper dosages of blood thinners such as Heparin. I
f a patient uses too small a dose, it may not prevent ...
Source: Mass Device - November 29, 2016 Category: Medical Equipment Authors: Sarah Faulkner Tags: Drug-Device Combinations Pharmaceuticals Research & Development 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
SentreHeart recalls FindrWIRZ Guidewire System over coating separation issues
SentreHeart is recalling a select number of its FindWIRZ guidewire systems over PTFE coating separation issues, according to an FDA release posted today.
The recall has been given a Class I label from the FDA, which indicates “a reasonable probability that use of these products will cause serious adverse health consequences or death,” according to the agency.
The FindrWIRZ guide wire system is designed for use during minimally invasive cerebrovascular, cardiovascular and peripheral vascular systems to help position over-the-wire catheters through the insertion of a thin flexible tube into arteries of the leg ...
Source: Mass Device - November 22, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Food & Drug Administration (FDA) Recalls Vascular SentreHeart Source Type: news
MassDevice.com +5 | The top 5 medtech stories for November 16, 2016
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 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.
Get this in your inbox everyday by subscribing to our newsletters.
5. St. Jude Medical’s HeartMate 3 implantable pump beats HeartMate II in pivotal trial
The next-generation HeartMate 3 implantable pump St. Jude Medical acquired when it paid $3 billion for Thoratec last year proved superior to ...
Source: Mass Device - November 16, 2016 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news
St. Jude Medical ’ s HeartMate 3 implantable pump beats HeartMate II in pivotal trial
The next-generation HeartMate 3 implantable pump St. Jude Medical (NYSE:STJ) acquired when it paid $3 billion for Thoratec last year proved superior to the older HeartMate II device at 6 months in pivotal clinical trial results released today.
The Momentum 3 study enrolled more than 1,000 patients for a short-term outcome after 6 months and a longer-term, 2-year outcome; the initial 6-month data comes from 294 subjects. Unlike the HeartMate II device, which uses an axial-flow pump, the HeartMate 3 device uses a centrifugal-flow pump designed to reduce the risk of blood clots.
The primary endpoint at 6 months was a compo...
Source: Mass Device - November 16, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiac Assist Devices Cardiovascular Clinical Trials American Heart Assn. New England Journal of Medicine St. Jude Medical Thoratec Corp. Source Type: news
FDA expands indication for Medtronic ’ s Solitaire stent retriever
Medtronic (NYSE:MDT) said today that the FDA granted 510(k) clearance for an expanded indication for its Solitaire stent retriever.
The new indication covers its use as an initial treatment for acute ischemic stroke after the administration of intravenous tissue plasminogen activator and within six hours of symptom onset, Fridley, Minn.-based Medtronic said. The Solitaire device is designed to remove clots from brain arteries using a micro-sized catheter.
“This expanded indication for the Solitaire device demonstrates Medtronic’s ongoing dedication to significantly improving the lives of stroke patients,”...
Source: Mass Device - November 16, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Regulatory/Compliance Medtronic Stroke Source Type: news
Computer-brain interface helps locked-in patient communicate, albeit slowly
(Reuters) – Doctors in the Netherlands say they have successfully tested an implantable computer-brain interface that allowed the mind of a “locked-in” patient to spell messages at the rate of two letters per minute.
The system was tested on a 58-year-old woman in the late stages of amyotrophic lateral sclerosis, or ALS. Unable to speak or move her muscles, she had to identify the letters by imagining that she was moving her right hand. Previously, her only method to communicate was through eye movements and blinks.
“We’ve built a system that’s reliable and autonomous that works at home ...
Source: Mass Device - November 14, 2016 Category: Medical Equipment Authors: MassDevice Tags: Neurological Source Type: news
MassDevice.com +5 | The top 5 medtech stories for November 14, 2016
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 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.
Get this in your inbox everyday by subscribing to our newsletters.
5. Final FDA rules clarify adverse event reporting for contract manufacturers
The FDA last week issued final guidance for medical device companies on the requirements for reporting adverse events that walked back much of the burde...
Source: Mass Device - November 14, 2016 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news
Prominent cardiologist calls for a halt to Watchman implants
A prominent cardiologist is calling for a stop to left atrial appendage closure procedures using Boston Scientific‘s (NYSE:BSX) Watchman device, claiming the procedures, which seek to reduce stroke in patients with nonvalvular atrial fibrillation, result in the opposite.
Dr. John Mandrola argues that randomized, controlled trials of the Watchman, designed for LAA closure, showed the device failed to reduce ischemic stroke, despite being designed for just that purpose.
“Yet we look away; or we let advocates distract us with complicated statistics,” Dr. Mandrola wrote in an article on Medscape. “Iâ€...
Source: Mass Device - November 10, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Cardiovascular Boston Scientific Source Type: news
SanBio touts 1-year data on stem cell transplant for stroke
SanBio Inc. (TYO:4592) released 1-year interim data from the phase 1/2a, open-label, single-arm dose escalation study of its intracerebral stem cell implant designed for stroke patients.
The Mountain View, Calif.-based company touted the results, which indicated that itsSB623 stem cell treatment was generally safe, well-tolerated and associated with improved motor functions in patients  suffering with chronic impairment following an ischemic stroke.
SanBio presented interim results from the study at the American Congress of Rehabilitation Medicine Conference last week, and claims that the study is the 1st of its kindÂ...
Source: Mass Device - November 4, 2016 Category: Medical Equipment Authors: Sarah Faulkner Tags: Drug-Device Combinations Neurological Research & Development Stem Cells SanBio Inc Source Type: news
Neuravi raises $16.7m
Neuravi said today it raised $16.7 million (EU €15 million) in a new round of debt financing, with funds slated to support U.S. commercialization and portfolio expansion.
Money in the round came from healthcare alternative financing provider IPF Partners, the Galway, Ireland-based company said.
Funds raised in the round will be invested into the U.S. commercialization of its products and expanding its stroke treatment portfolio, Neuravi said.
“With the recent European launch of the EmboTrap II device and the excellent progress in enrolling our pivotal clinical trial, we are making significant headway in delivering...
Source: Mass Device - November 2, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Blood Management Business/Financial News Vascular Neuravi Limited Source Type: news
Report: Boston Scientific pauses Lotus Edge heart valve in Europe
Boston Scientific (NYSE:BSX) is reportedly pausing implantations of its next-generation Lotus Edge replacement heart valve in Europe to investigate a locking mechanism issue.
Marlborough, Mass.-based Boston Scientific has implanted about 200 of the Lotus Edge transcatheter aortic valve replacements in Europe, according to Barclays analyst Matthew Taylor, encountering about a 4% rate of “some issues with [the] locking mechanism of the valve.”
“In these cases (incidence rate of ~4%), the device was recaptured and a new valve was implanted with no major adverse events,” Taylor wrote today in a note to...
Source: Mass Device - October 31, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiovascular Clinical Trials Replacement Heart Valves Boston Scientific TCT 2016 Transcatheter Cardiovascular Therapeutics symposium (TCT) Source Type: news
TCT 2016: Stents, stents, stents on Day 1
The annual Transcatheter Cardiovascular Therapeutics conference is under way in Washington, D.C., with late-breaking study results beginning yesterday. We’ll update this post throughout the day as new results come in, so be sure to check back for the latest news out of TCT 2016.
Stents took center stage Day1, with a raft of studies covering the latest on the bioresorbable front.
Stents equivalent to CABG
Drug-eluting stents are as effect as coronary artery bypass grafts in treating patients with blocked left main coronary arteries, according to a study that compared Abbott‘s (NYSE:ABT) Xience DES with CABG i...
Source: Mass Device - October 31, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiovascular Stents TCT 2016 Transcatheter Cardiovascular Therapeutics symposium (TCT) Source Type: news
