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Total 237 results found since Jan 2013.
FDA approves pivotal study of Vascular Dynamics MobiusHD high blood pressure device
Vascular Dynamics said today that the FDA approved an investigational device exemption for a clinical trial of its MobiusHD device for treating resistant hypertension.
MobiusHD is designed to help regulate blood pressure using electrodes implanted in the carotid artery to stimulate baroreceptors there.
Mountain View, Calif.–based Vascular Dynamics said the 300-patient Calm 2 study is designed to compare treatment with MobiusHD and a sham procedure. The primary safety endpoint is a composite of death, myocardial infarction, stroke, device embolization, carotid occlusion, new ipsilateral carotid stenosis requiring surgic...
Source: Mass Device - August 15, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Cardiovascular Clinical Trials Food & Drug Administration (FDA) Regulatory/Compliance vasculardynamics Source Type: news
Neural Analytics launches study of transcranial doppler for evaluating mild-TBI
Neural Analytics said today it enrolled the 1st patient in a 2-year study exploring the use of its Lucid M1 transcranial doppler ultrasound system to evaluate cerebral blood flow in patients with mild traumatic brain injuries.
The Lucid M1 system is a portable all-in-one ultrasound system designed for measuring and displaying cerebral blood flow velocities in patients with brain disorders, the Los Angeles, Calif.-based company said.
In the 240-patient trial, researchers at the University of California Los Angeles will examine high school and college age enrollees in 3 separate groups, including those who have been affected...
Source: Mass Device - August 10, 2017 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Diagnostics Neurological Neural Analytics Source Type: news
Keystone Heart looks to launch 3rd-gen TriGuard trials in 2017
Keystone Heart said yesterday it plans to launch a clinical trial of a 3rd-generation TriGuard cerebral embolic protection device by the end of the year.
The Israel-based company said the new device, dubbed the TriGuard 3, will offer technological improvements over previous versions of the device, and that it has accelerated the development program of the device.
Keystone Heart’s TriGuard devices are designed to protect the brain from emboli during transcatheter aortic valve replacement and other heart procedures to reduce stroke risk and brain damage.
The TriGuard 3 is designed to be anatomy independent and for a ...
Source: Mass Device - August 2, 2017 Category: Medical Devices Authors: Fink Densford Tags: Blood Management Clinical Trials Neurological Research & Development Keystone Heart Source Type: news
ReWalk Robotics touts Harvard-led Restore soft exosuit study
ReWalk Robotics (NSDQ:RWLK) today released results from a study of a soft suit exoskeleton system designed to aid ambulatory stroke patients, touting that the system was able to facilitate normal walking ability in patients.
The study was authored by researchers at Harvard University’s Wyss Institute for Biologically Inspired Engineering and Boston University, and utilized a prototype that Marlborough, Mass.-based ReWalk Robotics plans to commercialize as the Restore system.
Results from the study were published in the Journal of Science Translational Medicine.
The Restore system is designed to transmit power to ke...
Source: Mass Device - August 2, 2017 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Prosthetics Robotics ReWalk Robotics Source Type: news
Boston Scientific to end Renuvia bioresorbable coronary stent program
Boston Scientific (NYSE:BSX) is looking to terminate its Renuvia bioresorbable coronary stent program, according to a Minneapolis Star Tribune report.
The move comes after new clinical studies of Abbott‘s (NYSE:ABT) Absorb bioresorbable stent indicated that use of the device resulted in a higher risk of serious adverse events compared to metal stents.
Marlborough, Mass.-based Boston Scientific said that while the bioabsorbable plastic stents do “show promise”, the company will be focusing on different areas of development.
“We’ve just decided strategically that there are bigger problems to deal ...
Source: Mass Device - July 31, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cardiovascular Research & Development Stents Abbott Boston Scientific Source Type: news
Myomo wins CE Mark for next-gen MyoPro powered orthotic
Myomo said today it won CE Mark approval in the European Union for its next-gen MyoPro myoelectric arm orthosis device.
Cambridge, Mass.-based Myomo develops and produces myoelectric orthotics for patients with neuromuscular disorders, including its flagship MyoPro line. The orthosis devices are non-invasive, powered braces used to support weak or deformed arms and hands to allow for functional activity.
Myomo touted the MyoPro as the only lightweight wearable device designed to restore function to paralyzed or weakened arms and hands in individuals who have suffered a stroke, spinal cord or nerve injury or other neuromus...
Source: Mass Device - July 31, 2017 Category: Medical Devices Authors: Fink Densford Tags: Blog Myomo Inc Source Type: news
Medtronic wins CE Mark for CoreValve Evolut Pro
Medtronic (NYSE:MDT) said today it won CE Mark approval in the European Union for its CoreValve Evolut Pro transcatheter aortic heart valve, indicated for the treatment of severe aortic stenosis for symptomatic patients at intermediate, high or extreme risk for open heart surgery
The CoreValve Evolut Pro features an outer wrap to add surface area contact between the valve and the native aortic annulus to increase valve sealing performance, Fridley, Minn.-based Medtronic said.
“We are excited to introduce the next evolution of our Evolut TAVI platform to provide physicians in Europe with a comprehensive portfolio to ...
Source: Mass Device - July 31, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Catheters Regulatory/Compliance Replacement Heart Valves Medtronic Source Type: news
MassDevice.com +5 | The top 5 medtech stories for July 25, 2017
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. How a single drop of blood can detect sepsis
Sepsis can be identified by a single drop of blood, thanks to a lab-on-a-chip device from the University of Illinois.
Researchers at the University of Illinois and the Carle Foundati...
Source: Mass Device - July 25, 2017 Category: Medical Devices Authors: MassDevice Tags: News Well Plus 5 Source Type: news
Silk Road Medical raises $47m
Silk Road Medical said today it raised $47 million in a new funding round to support its Enroute products designed for transcarotid artery revascularization procedures.
The round was led by newly invested Norwest Venture Partners and Janus Capital Management funds and joined by existing investors Warburg Pincus, The Vertical Group and CRG, the Sunnyvale, Calif.-based company said.
Silk Road’s Enroute neuroprotection system is designed to allow physicians direct access to the common carotid artery in the neck to initiate high rate temporary blood flow reversal to protect the brain from stroke during implantations of ...
Source: Mass Device - July 18, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Vascular Silk Road Medical Inc. Source Type: news
FDA clears Medtronic ’ s CoreValve Evolut TAVR in intermediate risk patients
Medtronic (NYSE:MDT) said today it won expanded FDA approval for its CoreValve Evolut transcather aortic valve replacement platform, now indicated for patients with symptomatic severe aortic stenosis who are at an intermediate risk for open heart surgery.
The Fridley, Minn.-based company said that patients at intermediate risk for open-heart surgery have a mortality risk of greater than or equal to 3% at 30 days following the procedure.
“Patients at intermediate risk for open-heart surgery account for a large portion of the severe aortic stenosis population. We are delighted to take the self-expanding CoreValve Evo...
Source: Mass Device - July 10, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance Replacement Heart Valves Medtronic Source Type: news
Myomo touts reduced upper extremity impairment in MyoPro trial
This study is an important milestone supporting Myomo’s growing commercialization efforts. It clearly demonstrates the functional value of the MyoPro orthosis and how it meets a medical necessity. It provides useful information for clinicians who recommend and prescribe the device, as well as for payers. This is the first of several clinical studies that are underway that the company expects to see published over the coming months and years,” CEO & chair Paul Gudonis said in a prepared statement.
Earlier this month, Myomo said it launched its next-generation MyoPro 2 myoelectric arm orthosis designed to restore...
Source: Mass Device - June 30, 2017 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Prosthetics Myomo Inc Source Type: news
Report: New MRI technique improves brain scan accuracy
A new MRI technique could allow physicians to more accurately examine brain scans, according to an MIT News report.
Researchers at MIT, working with physicians at Massachusetts General Hospital and other institutions, have developed a way to boost the quality of the brain scans so that they can be used for large-scale studies on the effects of stroke and treatment responses, according to the report.
The scans could help researchers discover how genetic factors influence stroke survival, as well as serving as a new approach to understanding disorders such as Alzheimers, MIT News reported.
The new scanning approach involves ...
Source: Mass Device - June 22, 2017 Category: Medical Devices Authors: Fink Densford Tags: Imaging Neurological Source Type: news
ReWalk debuts Restore soft-suit exoskeleton prototype
ReWalk Robotics (NSDQ:RWLK) today debuted the prototype of its Restore soft suit exoskeleton designed to aid stroke survivors.
The company presented the prototype alongside collaborators from Harvard University’s Wyss Institute for Biologically Inspirde Engineering, and said it would focus on the suit as a “core company goal” for the fiscal year.
“We are thrilled with the progress of the Restore system, which will provide life changing technology to a whole new class of patients facing mobility issues. With the prototype finished, we are eager to begin clinical studies and pursue regulatory approva...
Source: Mass Device - June 19, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Robotics ReWalk Robotics Source Type: news
MassDevice Q & A: Claret Medical ’ s Azin Parhizgar on trying to make TAVR safer
Cerebral protection developer Claret Medical recently won FDA de novo clearance for its Sentinel device designed to trap blood clots and prevent stroke during heart valve replacement procedures.
The Sentinel uses a pair of filters, 1 in the brachiocephalic artery another in the left common carotid artery, to trap debris released during transcatheter aortic valve replacement that could cause a cerebral embolism.
The device has seen a rough road to approval, however, after missing the primary efficacy endpoint in its pivotal trial. Despite that, the device saw nearly unanimous support from an FDA advisory panel and was c...
Source: Mass Device - June 12, 2017 Category: Medical Devices Authors: Fink Densford Tags: Neurological Surgical Vascular Claret Medical Inc. Source Type: news
MassDevice.com +5 | The top 5 medtech stories for June 5, 2017
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. SentreHeart enters pivotal phase after hitting Lariat study milestone
SentreHeart can launch the 2nd, pivotal phase in the Amaze study of its Lariat device, after hitting the mark in the 1st, 100-patient stage.
Like the Watchma...
Source: Mass Device - June 5, 2017 Category: Medical Devices Authors: MassDevice Tags: News Well Plus 5 Source Type: news
