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Total 22 results found since Jan 2013.
ReWalk Robotics raises $4m
ReWalk Robotics (NSDQ:RWLK) has raised approximately $4.3 million in a new round of financing, according to recently posted SEC filings.
In the offering, ReWalk Robotics sold warrants to purchase ordinary shares at a purchase price of approximately $5.20, according to the filing. Warrants offered in the round have an exercise price of $5.14 and are exercisable for 5.5 years from the date of issuance. Warrants were issued on April 5, ReWalk Robotics said.
Money in the round came from three unnamed investors, with the first date of sale noted as having occurred on April 3.
The company is looking to raise an additional appro...
Source: Mass Device - April 9, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Robotics Wall Street Beat ReWalk Robotics Source Type: news
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.
Get the full story on our sister site, Medical Design & Outsourcing.
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
Samsung ’ s NeuroLogica, MaxQ AI ink collab distro deal
Samsung Electronics (LON:BC94) subsidiary NeuroLogica said today that it inked a distribution deal with MaxQ AI to integrate its artificial intelligence software with NeuroLogica’s medical imaging tech in the U.S. and EU’s acute care marketplace.
Through the deal, NeuroLogica said that it will offer MaxQ’s Accipio IX, part of the AI-company’s FDA-cleared and CE Mark approved Accipio Insight intracranial hemorrhage platform intended to support acute care physicians by identifying patients with suspected intracranial hemorrhage using non-contrast head computed tomography imaging.
“We are honore...
Source: Mass Device - November 20, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Distribution Imaging Neurological Software / IT maxqai NeuroLogica Corp. samsung Source Type: news
Edwards Lifesciences wins CE Mark for Sapien 3 Ultra TAVR
Edwards Lifesciences (NYSE:EW) said today it won CE Mark approval in the European Union for its Sapien 3 Ultra transcatheter aortic valve replacement system intended for patients with severe, symptomatic aortic stenosis.
Despite winning a CE Mark, Edwards said that the new valve will not be launched in Germany due to a preliminary injunction from rival Boston Scientific (NYSE:BSX). The company said that “the German court will hold a full hearing on the merits of the dispute” mid-next year, and that it is hopeful it will prevail.
The company said it will introduce the Sapien 3 Ultra in the rest of Europe as pa...
Source: Mass Device - November 16, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Featured Regulatory/Compliance Replacement Heart Valves Edwards Lifesciences Source Type: news
Dynatronics taps ex-NinePoint CEO von Jako as chief exec | Personnel Moves – July 11, 2018
Dynatronics said late last month it tapped former NinePoint Medical CEO Christopher von Jako as its new chief executive officer and board member, succeeding Kelvyn Cullimore Jr. who will stay on the company’s board of directors.
Prior to joining Dynatronics, von Jako acted as prez & CEO of NinePoint Medical. Before joining Nine Point, von Jako also served as prez & CEO of NeuroTherm, prez of ActiViews and held positions with medtech companies including Integra LifeSciences, Covidien and Medtronic.
“After thorough succession planning and a comprehensive search process, the board is pleased to have foun...
Source: Mass Device - July 11, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News AngioDynamics berkshiresterilemanufacturing Corindus Vascular Robotics Dynatronics Corp Guerbet integer MedPlast Medtronic Myomo Inc NinePoint Medical Inc. Pavmed viant Source Type: news
Stryker wins $3m tax break for Utah facility expansion
Stryker (NYSE:SYK) has won a $3.4 million tax-rebate incentive from the state of Utah to expand its neurotechnology training and manufacturing center in Salt Lake City, according to a Salt Lake Tribune report.
Kalamazoo, Mich.-based Stryker aims to add 540 people and spend $100 million over the next 10 years as part of the expansion, according to the report.
As part of the tax break deal, workers hired by Stryker will be required to be paid 100% of the average wage in Salt Lake County, resulting in new wages of $192 million and $17 million in state tax revenue, the SL Tribune reports.
“World-class companies like Str...
Source: Mass Device - October 13, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Stryker Source Type: news
HRS releases CIED lead extraction guidelines
The Heart Rhythm Society this week released its guidelines on device lead management and extraction for implantable cardiovascular electronic devices.
The new guidelines are the result of a collaboration amongst 10 international organizations, according to the HRS.
Included contributing organizations are the HRS, American College of Cardiology, American Heart Association, Asia Pacific Heart Rhythm Society, American Society of Anesthesiologists, European Heart Rhythm Association, Infectious Diseases Society of America, Latin American Hearth Rhythm Society, Pediatric and Congenital Electrophysiology Society and the Society o...
Source: Mass Device - September 15, 2017 Category: Medical Devices Authors: Fink Densford Tags: Blog Heart Rhythm Society 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
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
Cardiologs wins FDA 510(k) for ECG analysis platform
Cardiologs Technologies said today it won FDA 510(k) clearance for its Cardiologs ECG analysis platform designed to aid in the screening for atrial fibrillation and other arrhythmias.
The platform is a cloud-based cardiac monitoring and analysis web service which uses artificial intelligence to analyze long-term ambulatory ECG monitoring recordings, the Paris-based company said. The system already has CE Mark approval in the European Union, the company added.
“It is intuitive that screening for AFib and subsequent anticoagulant treatment should reduce the stroke burden, which is the basis of guideline recommendations...
Source: Mass Device - July 6, 2017 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance cardiologstechnologies 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
4 Key Insights When Raising Money for Your Medtech Startup: Interview with Bruce Shook, CEO of Intact Vascular
Welcome to the Medsider interview series, a regular feature at MassDevice. All interviews are conducted by Scott Nelson, Founder of Medsider and Group Director for WCG. We hope you enjoy them!
Bruce Shook joined Intact Vascular in 2014 as President and CEO. A highly-experienced, medical device executive with more than 30 years of industry experience, Bruce was previously Co-founder, Director, President, and CEO of Neuronetics, which is a privately held medical device company that markets a non-invasive brain stimulation technology for the treatment of depression.
Previously, Shook was Co-founder, Director, President, an...
Source: Mass Device - February 27, 2017 Category: Medical Equipment Authors: Danielle Kirsh Tags: Blog medsider 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
Nico touts studies using BrainPath to treat hemorrhagic stroke
Nico Corp today released data from 2 recently published studies which utilized its BrainPath Approach to treat hemorrhagic stroke, touting a 95% clot reduction and no mortalities associated with the device.
The BrainPath system uses a shunt and specially designed instrumentation to give surgeons access to the subcortical section of the brain. The device won 510(k) clearance from the FDA last June for treating primary and secondary brain tumors, vascular abnormalities, intraventricular tumors or cysts.
Data from the studies was published in the journals Neurosurgery and Operative Neurosurgery, the Indianapolis-based c...
Source: Mass Device - June 29, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Neurological Surgical Nico Corp. Source Type: news
Helius touts 6-patient study of advanced MS cases
Helius Medical Technologies this week released the result of a 6-patient pilot study of its PoNS therapy used to treat the advanced symptoms of multiple sclerosis, touting improvements in physical, cognitive and quality of life parameters.
Data from the study was presented at the 2016 Annual Meeting of the Consortium of Multiple Sclerosis Centers this month, the Newtown, Penn.-based company said.
“Those with greater functional ability at the beginning of the study (EDSS 6.5-7.0) made the most significant gains but all subjects could be qualified as improved. The intervention shows promise to prolong functional ambula...
Source: Mass Device - June 24, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Clinical Trials Neuromodulation/Neurostimulation Helius Medical Technologies Source Type: news
