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Total 467 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
Bionik Labs integrates Amazon voice control tech into Arke lower body exoskeleton
Robotic rehabilitation device developer Bionik Laboratories said today it integrated Amazon‘s (NSDQ:AMZN) Echo and Alexa voice technology into its Arke lower body exoskeleton.
With the integration users of the Arke exoskeleton will be able to control the system and its various activity modes, including standing and walking, through voice commands, the Toronto-based company said.
“We are excited to complete the integration of Amazon’s Echo and Alexa into our Arke exoskeleton, combining the power of Amazon’s voice-activated technologies with our powerful assistive robotic solutions for the next evolut...
Source: Mass Device - August 8, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Robotics Bionik Laboratories 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
7 ways neurostimulation could make our lives better
[Image from dierk schaefer on Flickr]Neurostimulation is being used for a lot of different things that go beyond motor disorders and diseases. Neurostimulation is used to stimulate certain parts of the brain’s nervous system. It can be invasive with implants or it can be non-invasive with electrode-filled caps and ear clips.
The neurostimulation market was worth an estimated $1.9 billion in 2016 and expected to double to almost $4 billion by 2025, according to a ReportBuyer analysis. The continuously growing range of applications and updates in the technology are contributing to the fast growth.
From devices to tr...
Source: Mass Device - July 27, 2017 Category: Medical Devices Authors: Danielle Kirsh Tags: Neurological Neuromodulation/Neurostimulation Pain Management Research & Development Cleveland Clinic Hartford Healthcare Massachusetts Institute of Technology Medtronic Northwestern University University of Washington Source Type: news
UPDATE: Aspect Imaging wins FDA 510(k) for Embrace neonatal MRI
Updated to include comment from Aspect Imaging
The FDA today granted 510(k) clearance to Aspect Imaging‘s Embrace Neonatal magnetic resonance imaging device, which it touted as the 1st MRI device specifically designed for neonatal brain and head imaging.
The Embrace Neonatal MRI system is designed specifically for imaging neonatal heads, and can be used on nenonates with a head circumference of up to 38 cm and a weight between 1 and 4.5 kg, according to an FDA release. The system includes a temperature-controlled incubator which can be placed directly into the MRI system to reduce movement.
“The vision of Aspec...
Source: Mass Device - July 27, 2017 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Food & Drug Administration (FDA) Imaging Regulatory/Compliance Aspect Imaging 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.
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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
FDA recalls Penumbra 3D Revascularization device over wire separation issues
The FDA today released a recall notice for Penumbra‘s (NYSE:PEN) 3D Revascularization Device, part of its Penumbra system designed to remove thrombus from brain blood vessels during strokes, over issues with wire breaks and separations.
The FDA labeled the recall as Class I, its most serious designation, indicating that there is a reasonable probability that use of the product could cause serious adverse health consequences or death.
The 3D Revascularization device is designed to restore blood flow or remove blood clots in blood vessels in the brain during acute ischemic stroke in patients who are ineligible or fail...
Source: Mass Device - July 21, 2017 Category: Medical Devices Authors: Fink Densford Tags: Blood Management Food & Drug Administration (FDA) Neurological Recalls Vascular Penumbra Inc. Source Type: news
Aspect Imaging wins FDA 510(k) for Embrace neonatal MRI
The FDA today granted 510(k) clearance to Aspect Imaging‘s Embrace Neonatal magnetic resonance imaging device, which it touted as the 1st MRI device specifically designed for neonatal brain and head imaging.
The Embrace Neonatal MRI system is designed specifically for imaging neonatal heads, and can be used on nenonates with a head circumference of up to 38 cm and a weight between 1 and 4.5 kg, according to an FDA release. The system includes a temperature-controlled incubator which can be placed directly into the MRI system to reduce movement.
The system allows for urgent access to the neonates if necessary, with th...
Source: Mass Device - July 20, 2017 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Food & Drug Administration (FDA) Imaging Regulatory/Compliance Aspect Imaging Source Type: news
Cardiac imaging dev VerAvanti raises $5m
Previously-stealthy cardiac imaging developer VerAvanti said today it raised $5 million in a recent round of financing to support its Scanning Fiber Endoscope device development.
The Redmond, Wash.-based company’s SFE device uses technology licensed from the University of Washington and consists of an imaging station and micro-sized catheter which can take high-quality images inside of vessels to improve the diagnosis and treatment of stroke and other heart conditions.
VerAvanti said that it has received 2 NIH research Phase 1 grants totaling $586,000 in May and June, alongside support from the company’s founder Ge...
Source: Mass Device - July 18, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cardiovascular Imaging VerAvanti Source Type: news
Rapid Medical raises $9m in Series B for neurovascular devices
Neurovascular device maker Rapid Medical said today it closed a $9 million Series B round of financing to support its minimally invasive stroke treatment and prevention devices.
Rapid Medical produces the Tigertriever revascularization device and Comaneci adjustable remodeling mesh designed for neurovascular use, the Israel-based company said.
The company touted the Tigertriever as the only controllable, fully-visible stent retriever which can be adjusted by the physician to fit in the dimensions of the blocked blood vessel and the Comaneci as the 1st-ever controllable, fully-visible aneurysm neck-bridging mesh device whic...
Source: Mass Device - July 18, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Neurological Vascular rapidmedical Source Type: news
