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Source: Mass Device
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Total 467 results found since Jan 2013.
ReWalk Robotics files for exoskeleton suit clearance
ReWalk Robotics’ exo-suit designed for stroke rehabilitation.
ReWalk Robotics (NSDQ:RWLK) said it has applied to FDA for 510(k) clearance of its ReStore exoskeleton suit for gait training during stroke rehabilitation.
The Yokneam, Israel-based company designed its exo-suit to provide coordinated plantarflexion and dorsiflexion assistance to a patient’s foot and ankle. It recently won insurer reimbursement from Cigna and completed a clinical trial involving 44 patients at five rehabilitation centers in the U.S.
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The post ReWalk Robotics file...
Source: Mass Device - February 19, 2019 Category: Medical Devices Authors: Nancy Crotti Tags: 510(k) Blog Business/Financial News Food & Drug Administration (FDA) Neurological News Well Regulatory/Compliance Robotics ReWalk Robotics Source Type: news
IschemaView launches Rapid Angio neuroimaging system
Medical imaging dev IschemaView said yesterday that it launched its Rapid Angio neuroimaging system designed for use in the angiography suite.
The Menlo Park, Calif.-based company said that it partnered with Siemens (NYSE:SI) to integrate the Rapid software with Siemens’ SyngoDynaCT multiphase system for the newly launched imaging solution.
Siemens’ SyngoDyna CT Multiphase is a 3D image acquisition technique which uses multiple rotations of a C-arm system to acquire multi-phasic 3D representation of the brain and its perfusion.
“The Rapid Angio module, by combining the best-in-class syngoDynaCT system...
Source: Mass Device - March 1, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Imaging Neurological ischemaview Source Type: news
Press Release: Medtronic Announces Canadian Launch of Miniature Cardiac Monitor, Reveal LINQ™ ICM
Small, Wireless Monitor Provides Long-Term Remote Monitoring to Help Physicians Diagnose and Monitor Irregular Heartbeats.
BRAMPTON, ON--(Marketwired - May 13, 2014) - Medtronic of Canada today announced it has received Health Canada license for the Reveal LINQ Insertable Cardiac Monitor (ICM), the smallest implantable cardiac monitoring device available for patients with irregular heartbeats, unexplained syncope (fainting), or unexplained stroke.
MedtronicNews Well, Cardiac Rhythm Management, Implants, Minnesota, Patient Monitoring, Remote Patient Monitoringread more
Source: Mass Device - May 13, 2014 Category: Medical Equipment Authors: MassDevice Source Type: news
Axonia raises $2M in seed funding for nerve repair grafts
Axonia Medical secures $2 million in seed financing in supports of its nerve restoration and repair technologies.
Michigan startup Axonia Medical the close of a $2 million seed financing round that the company plans to use to further develop its nerve repair and restoration technologies.
Axonia aims to repair damage associated with nerve injuries, such as peripheral nerve injury, spinal cord injury, traumatic brain injury and stroke, and area with "a remarkable absence of viable treatment options," the company said.
AxoniaNews Well, Funding Roundup, Regenerative Medicineread more
Source: Mass Device - June 9, 2014 Category: Medical Equipment Authors: Arezu Sarvestani Source Type: news
Medtronic acquires Covidien in a $43 billion deal | Medtech Wall Street news for the week of June 16, 2014
Here's a look at some of the top Wall Street stories for medical device companies this week: Blockbuster: Medtronic in $43B deal to acquire Covidien; Medtronic buyout holds $80M in golden parachutes for Covidien execs; FDA wants another panel hearing on Boston Scientific's Watchman anti-stroke device; European Commission tables review of Zimmer's $13B acquisition of Biomet; Ackman takes Allergan to court to defend against poison pill
Blockbuster: Medtronic in $43B deal to acquire Covidien
June 16, 2014 by Brad Perriello
Zimmer Holdings, Biomet, Boston Scientific, Covidien, European Commission, Food & Drug ...
Source: Mass Device - June 19, 2014 Category: Medical Equipment Authors: MassDevice Source Type: news
Study: Medtronic's Reveal XT bests conventional follow-up
A clinical study of Medtronic's Reveal XT cardiac monitor is superior to conventional follow-up in identifying atrial fibrillation after cryptogenic stroke.
Medtronic, New England Journal of MedicineNews Well, Clinical Trials, Patient Monitoringread more
Source: Mass Device - June 26, 2014 Category: Medical Equipment Authors: Brad Perriello Source Type: news
Boston Scientific's Watchman misses 1 of 2 efficacy goals in PREVAIL trial
Medtech titan Boston Scientific finally unveils the full results from its PREVAIL study, which was the subject of controversy at last year's ACC conference.
Boston Scientific (NYSE:BSX) this week unveiled full results from the PREVAIL clinical trial of the Watchman anti-stroke implant, largely agreeing with earlier reports that the device missed a co-primary endpoint for efficacy.
American College of Cardiology, Boston ScientificNews Well, Clinical Trials, American College of Cardiology Conference (ACC), Cardiac Implants, Conference coverageread more
Source: Mass Device - July 1, 2014 Category: Medical Equipment Authors: Arezu Sarvestani Source Type: news
DePuy's Codman Neuro expands in Asia Pacific with new approvals
Codman Neuro prepares to widen its Asia Pacific footprint with regulatory approvals in China, South Korea and Taiwan for its Revive SE thrombectomy system.
Massachusetts-based Codman Neuro is preparing to take Asia Pacific by storm with new regulatory wins in China, South Korea and Taiwan for the company's Revive SE thrombectomy device.
Codman Neuro, DePuy SynthesNews Well, Regulatory/Clearance, Stroke, Vascularread more
Source: Mass Device - September 8, 2014 Category: Medical Equipment Authors: Arezu Sarvestani Source Type: news
Neurovascular: Covidien begins enrollment in 2 new trials
Covidien begins enrolling patients in clinical trials for its Pipeline embolization system as well as all its endovascular stroke devices.
Covidien (NYSE:COV) announced today that it enrolled the 1st patients in a pair of clinical trials evaluating the company's neurovascular technologies.
CovidienNews Well, Clinical Trials, Neurovascular repairread more
Source: Mass Device - September 15, 2014 Category: Medical Equipment Authors: Arezu Sarvestani Source Type: news
New data not so good for Boston Scientific's Watchman anti-stroke device
New data presented last week at the annual Transcatheter Cardiovascular Therapies meeting showed Boston Scienfitic's Watchman anti-stoke device to be comparable to treatment with the anti-coagulant warfarin.
Boston Scientific, TCT 2014News Well, Clinical Trials, Cardiac Implantsread more
Source: Mass Device - September 22, 2014 Category: Medical Equipment Authors: Scott Wooldridge Source Type: news
The last reprogramming
Westby G. Fisher, MD, FACC is a board certified internist, cardiologist, and cardiac electrophysiologist practicing at NorthShore University HealthSystem in Evanston, IL, USA and is a Clinical Associate Professor of Medicine at University of Chicago's Pritzker School of Medicine.
By Westby G. Fisher, MD, FACC
He had called the other day to update me up on his condition. He did not sound upset, but resolute. "They offered me peritoneal dialysis," he said, "but I decided against it and figured I'd just let nature take its course. The hospice people are so wonderful - I've got things all set here at home, but I ha...
Source: Mass Device - September 29, 2014 Category: Medical Equipment Authors: MassDevice Tags: Dr. Wes Source Type: news
FDA doubtful on new Watchman data from Boston Scientific
The FDA expresses some doubts about new data from Boston Scientific on its Watchman anti-stroke device.
Boston Scientific, Food & Drug Administration (FDA)News Well, Clinical Trials, Cardiac Implants, Regulatory/Complianceread more
Source: Mass Device - October 6, 2014 Category: Medical Equipment Authors: Brad Perriello Source Type: news
FDA panel offers mixed view on Boston Scientific Watchman device
An FDA advisory panel gives a mixed view in its unprecedented 3rd review of Boston Scientific's Watchman anti-stroke device.
Boston Scientific, Food & Drug Administration (FDA)News Well, Cardiac Implants, Regulatory/Complianceread more
Source: Mass Device - October 9, 2014 Category: Medical Equipment Authors: MassDevice Source Type: news
Kimberly-Clark plans to spin out Halyard Health as a separately traded company | Medtech Wall Street news for the week of October 13, 2014
Here's a look at some of the top Wall Street stories for medical device companies this week: Kimberly-Clark to spin out Halyard Health Oct. 31; 3rd FDA panel vote barely favors Boston Scientific's Watchman anti-stroke device; Irish tax changes may cost U.S. groups billions; InspireMD drops MGuard stent in the U.S., shares slide; ConvaTec owners appoint banks to explore sale: sources
Kimberly-Clark to spin out Halyard Health Oct. 31
October 9, 2014 by Alexander Soule
Boston Scientific, ConvaTec, Covidien, Food & Drug Administration (FDA), Halyard Health, InspireMD, Kimberly-Clark Worldwide Inc., Medtronic, 3...
Source: Mass Device - October 16, 2014 Category: Medical Equipment Authors: MassDevice Source Type: news
Boston Scientific touts 1st Watchman implantations
Boston Scientific touts the 1st commercial implantations of its Watchman anti-stroke heart implant.
Boston ScientificNews Well, Cardiac Implantsread more
Source: Mass Device - March 25, 2015 Category: Medical Equipment Authors: Brad Perriello Source Type: news
