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Total 14 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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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
ReWalk Robotics shares fall on Q4, 2018 sales miss
Shares in ReWalk Robotics (NSDQ:RWLK) fell today after the rehabilitation exoskeleton maker posted fourth quarter and full year 2018 earnings that beat loss-per-share expectations but missed wide on sales consensus from Wall Street analysts.
The Yokneam, Israel-based company posted losses of approximately $5 million, or 10¢ per share, on sales of approximately $1.6 million for the three months ended December 31, seeing losses shrink 18.6% while sales grew 4.2% when compared with its fourth quarter during the previous year.
Losses per share were just ahead of the 14¢ consensus on Wall Street, where analysts expected too ...
Source: Mass Device - February 8, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Featured MassDevice Earnings Roundup Wall Street Beat ReWalk Robotics Source Type: news
InspireMD inks distro deal for CGuard in South Africa
InspireMD (NYSE:NSPR) said today that it inked a deal with Torque Medical to distribute its CGuard Embolic Prevention System in South Africa.
The Israel-based company reported that it will begin the commercial launch for CGuard in South Africa immediately.
“We are extremely pleased with the opportunity to offer CGuard EPS in the South African market. We were approached by some of our key customers in the Vascular Surgery, Interventional Neurology and Interventional Cardiology field who had learned about CGuard EPS through conferences and publications and wanted us to make it available in South Africa,” Craig G...
Source: Mass Device - January 14, 2019 Category: Medical Devices Authors: Sarah Faulkner Tags: Business/Financial News Distribution Featured Vascular Wall Street Beat InspireMD Source Type: news
Neovasc touts Tiara TMVR success rate in study
A small study of the Neovasc (NSDQ:NVCN) Tiara transcatheter mitral valve replacement (TMVR) in high-risk patients revealed a 100% procedural success rate and immediate elimination of mitral regurgitation.
Published in Circulation: Cardiovascular Interventions, the study also showed no death, myocardial infarction, stroke, major bleeding, or access site complications at 30 days. The twelve patients in the study had had a previous aortic valve replacement. Such patients have been excluded from most TMVR trials because of the potential risks of left ventricular outflow tract obstruction or interaction between the TMVR anch...
Source: Mass Device - October 16, 2018 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Cardiac Implants Cardiovascular Featured Replacement Heart Valves Research & Development Mayo Clinic neovasc Neovasc Inc. Source Type: news
Rapid Medical wins CE Mark for Tigertriever 13 stent retriever
Neurovascular device maker Rapid Medical said it won CE Mark approval in the European Union for its Tigertriever 13 stent retriever intended for treating ischemic stroke, and added that the first patient in the region has been treated with the device.
The Israel-based company touted the Tigertriever 13 as the first-ever fully-visible stent retriever that can be adjusted by the physician to fit in the dimensions of the blocked blood vessel.
Rapid Medical said that the device’s profile is 83% smaller than any other devices on the market, and that it is designed to recanalyze intracranial vessels of between 1mm and 2....
Source: Mass Device - July 31, 2018 Category: Medical Devices Authors: Fink Densford Tags: Regulatory/Compliance Vascular rapidmedical Source Type: news
Silk Road Medical touts TCAR study data
Silk Road Medical today released results from studies of its transcarotid artery revascularization procedure, touting favorable outcomes in treating patients with carotid artery disease.
Data from the studies were presented at the Society for Vascular Surgery 2018 Vascular Annual Meeting in Boston.
The transcarotid artery revascularization procedure uses the Sunnyvale, Calif.-based company’s Enroute transcarotid stent and neuroprotection system, and is intended to treat blockages in the carotid artery that are at risk of causing a stroke.
Results from a two-year study which compared outcomes from 1,182 patients who r...
Source: Mass Device - June 29, 2018 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Vascular Silk Road Medical Inc. Source Type: news
Keystone Heart launches new TriGuard embolic protection study
Keystone Heart said today it launched the second phase of its Reflect trial evaluating the safety and efficacy of its third-generation TriGuard cerebral embolic protection device.
In the trial, investigators will explore the use of the TriGuard 3 and its ability to protect a patient’s brain from emboli during transcatheter aortic valve replacement procedures, the Israel-based company said.
“Knowing what we now know about the significant risks of stroke and other neurological injury associated with TAVR and other cardiovascular procedures, there is a clear unmet clinical need for cerebral embolic protection devi...
Source: Mass Device - May 31, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Clinical Trials Neurological Keystone Heart Source Type: news
ReWalk Robotics inks $20m private placement, posts Q4, 2017 earnings
Shares in ReWalk Robotics (NSDQ:RWLK) have risen today after the company announced a $20 million private placement and posted shrinking losses for the quarter and growing sales for the year with its fourth quarter and 2017 earnings.
The company said it inked an investment agreement with Hong Kong-based Timwell Corporation Limited through which the company will receive $20 million in three tranches through the issuance of 16 million shares at a price of $1.25 per share.
The investment will come in three tranches, with $5 million for an initial 4 million shares in the first, $10 million for 8 million shares in the second an...
Source: Mass Device - March 8, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News MassDevice Earnings Roundup Wall Street Beat ReWalk Robotics Source Type: news
Perflow Medical closes $12m round to support Stream Net thrombectomy device
Israel-based neurovascular device developer Perflow Medical said it closed a $12 million round of financing to help support its Stream dynamic neuro-thrombectomy net designed for treating acute ischemic stroke.
Funding from the round will support the European commercialization of the company’s first product, the Stream Net device, and a 510(k) submission to the FDA in pursuit of US approval.
Funds will also help support development of two new products based off the company’s Cerebral Net technology platform for aneurysm neck bridging and flow diversion procedures.
The Stream Net device is designed to treat acut...
Source: Mass Device - February 16, 2018 Category: Medical Devices Authors: Fink Densford Tags: Blood Management Business/Financial News Neurological perflowmedical Source Type: news
TCT 2017: Medtronic touts results from 6-month Evolut Pro study
Medtronic (NYSE:MDT) today released six-month data from a study of its Evolut Pro transcatheter aortic valve replacement platform, touting low rates of paravalvular leaks and low rates of all-cause mortality and disabling stroke.
Data came from 60 patients in the trial who received the Evolut Pro valve, and follow previously released 30-day outcomes.
Results at six-months indicated trace or no paravalvular leaks in 88% of patients, with low rates of all-cause mortality and disabling stroke. No instances of coronary obstruction or valve thrombosis were reported and the permanent pacemaker implantation rate was 11.7%, Medt...
Source: Mass Device - November 2, 2017 Category: Medical Devices Authors: Fink Densford Tags: Catheters Clinical Trials Replacement Heart Valves Medtronic Source Type: news
Rapid Medical launches Tigertriever registry study
Neurovascular device maker Rapid Medical said it launched a registry study of its Tigertreiver controllable stent retriever.
The Israel-based company touts 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.
The newly launched European multi-center registry study looks to enroll patients in France and Switzerland, and will be the 1st to examine the use of the Tigertriever in a real-life setting. The company said it has enrolled its 1st patient in the trial at Switzerland’s Cantonal Hospital of Lucerne.
...
Source: Mass Device - September 19, 2017 Category: Medical Devices Authors: Fink Densford Tags: Catheters Clinical Trials Stents rapidmedical Source Type: news
MassDevice.com +5 | The top 5 medtech stories for September 15, 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. FDA cuts could threaten medtech innovation: Here’s why
The Trump administration’s proposed federal budget could hurt the speed and quality of FDA review times, says a top expert at Musculoskeletal Clinical Regulatory Advise...
Source: Mass Device - September 15, 2017 Category: Medical Devices Authors: MassDevice Tags: News Well Plus 5 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
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
