Filtered By:
Source: Mass Device
Condition: Disability
This page shows you your search results in order of date.
Order by Relevance | Date
Total 24 results found since Jan 2013.
FDA clears Imperative Care ’ s stroke treatment catheters
Stroke-treatment startup Imperative Care (Campbell, Calif.) said it has landed FDA approval for its first line of access catheters.
Access to brain blood vessels can be challenging because of the brain’s highly complex and twisted vascular structure. The catheters were designed to deliver interventional treatments during minimally invasive neurovascular procedures for aneurysms, stroke, and other brain blood-vessel conditions, the company said.
“Recognizing the significant need to elevate the standard of patient therapeutics in stroke, Imperative Care was founded to become the comprehensive stroke company innovat...
Source: Mass Device - January 24, 2019 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Business/Financial News Food & Drug Administration (FDA) Neurological News Well Research & Development imperativecare Source Type: news
Corindus touts first-in-human coronary telerobotics study with CorPath system
Corindus Vascular Robotics (OTC:CVRS) today touted that its CorPath robotic surgical platform was used in a first-in-human telerobotic intervention study in India.
The Waltham, Mass.-based company touted that the study was the world’s first percutaneous coronary intervention conducted from a remote location outside of a catheterization lab.
In the trial, five patients at India’s Apex Heart Institute underwent an elective PCI procedure from a distance of approximately 20 miles away, Corindus said.
The procedures were performed by Apex Heart Institute chair and chief interventional cardiologist Dr. Tejas Patel f...
Source: Mass Device - December 6, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Clinical Trials Featured Robotics Corindus Vascular Robotics Source Type: news
Study: Delaying thombectomy, even for minutes, can lead to lifelong consequences
Delaying endovascular thrombectomy treatment for patients with acute ischemic stroke can take time off of patient’s lives and cost hospitals extra, according to a new study reported by Medscape.
Results from the study were presented by Dr. Wolfgang Kunz of Munich, Germany’s Ludwig Maximilian University during the 11th World Stroke Congress.
Every hour of delay within the first six resulted in, on average, a loss of approximately 0.6 quality-adjusted life years, or approximately 7.7 months of disability-free life, according to the report.
Beyond patient outcomes, every hour of delay also reduces the economic value o...
Source: Mass Device - October 25, 2018 Category: Medical Devices Authors: Fink Densford Tags: Blood Management Clinical Trials Vascular Source Type: news
Google joins $21m Series A for Viz.ai
Artificial Intelligence healthcare developer Viz.ai has raised $21 million in a Series A funding round joined by GV, formerly known as Google Ventures.
The round was led by Kleiner Perkins, the San Francisco-based company said. In connection with the funding round, Kleiner Perkins general partner Mamoon Hamid will join the company’s board of directors.
“We were attracted not only to the technology behind Viz.ai and its impact on patient outcomes, but also its adoption model. Many new health-tech solutions struggle to gain traction because they are an outside-in sale to medical teams, requiring changes to proc...
Source: Mass Device - July 19, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Funding Roundup vizai Source Type: news
ReWalk Robotics amends soft exoskeleton research, licensing deal with Harvard
UPDATE: Corrected to reflect that ReWalk Robotics was amending an earlier deal.
ReWalk Robotics (NSDQ:RWLK) has inked a set of amendments to its collaborative research and exclusive licensing agreement with Harvard Collage related to the development of its soft-suit exoskeleton, according to a recently posted SEC filing.
Through the original collaborative deal, both groups will join to aid in the development of soft-suit exoskeleton technologies designed to treat lower limb disabilities, the Marlborough, Mass.-based company said. The suit is intended to treat stroke, multiple sclerosis, mobility limitations for the elderl...
Source: Mass Device - July 2, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Research & Development Robotics ReWalk Robotics Source Type: news
ReWalk Robotics expands ReStore soft exo-suit trial
ReWalk Robotics (NSDQ:RWLK) said today that it plans to expand the clinical study of its ReStore soft exo-suit device to five U.S. research centers.
The Marlborough, Mass.-based company expects to launch its ReStore device for stroke patients in Europe and the U.S. in the first half of 2019. The exo-suit is designed as a gait therapy solution, providing coordinated plantarflexion and dorsiflexion assistance to a patient’s foot and ankle. ReWalk plans to price the system at under $20,000.
Enrollment for the company’s multi-center study is ongoing. The five centers involved in the trial include the Shirley Ryan ...
Source: Mass Device - June 28, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Clinical Trials Neurological Robotics Wall Street Beat ReWalk Robotics Source Type: news
Stryker wins expanded FDA indications for Trevo thrombectomy device
Stryker (NYSE:SYK) said today it won expanded FDA indications for its Trevo thrombectomy device, now cleared as a front-line treatment for acute ischemic stroke patients for up to 24 hours from symptom onset.
The expanded indication lifts the previously cleared treatment window by 18 hours, according to the Kalamazoo, Mich.-based company.
“The 24-hour indication opens the treatment window to patients whose stroke would previously have progressed until all the brain tissue surrounding the affected arteries was dead, leaving them with a life of significant disabilities. These patients now have a much better chance for...
Source: Mass Device - February 15, 2018 Category: Medical Devices Authors: Fink Densford Tags: Blood Management Food & Drug Administration (FDA) Regulatory/Compliance Vascular Stryker Source Type: news
Stryker touts NEJM publication of Trevo thrombectomy device trial results
Stryker (NYSE:SYK) yesterday released results from the Dawn trial of its Trevo thrombectomy device, touting significant effects even when used beyond six hours after stroke.
Results from the trial were published in the New England Journal of Medicine, the Kalamazoo, Mich.-based company said.
“By quadrupling the size of the therapeutic time window, the consequence of Dawn is that many more patients with large vessel occlusion stroke have the potential to be treated with mechanical thrombectomy. Dawn validates the physiological, rather than time-based approach to patient selection for endovascular therapy,” co...
Source: Mass Device - November 14, 2017 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Vascular Stryker 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
ReWalk Robotics inks French distro deal with Harmonie M édical Service
ReWalk Robotics (NSDQ:RWLK) said today it inked an exclusive French distribution deal with Harmonie Médical Service.
Through the deal, HMS will operate as sole distributor of the ReWalk exoskeleton systems for individuals with spinal cord injuries in France. The deal includes both the ReWalk Personal and ReWalk Rehabilitation systems for home and clinical use, respectively.
“Our partnership with ReWalk is a real opportunity for HMS. We have been working for 30 years in the medical materials domain with people who have lost their mobility. We have always looked for innovative technologies in this domain, especially...
Source: Mass Device - July 11, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Distribution Robotics ReWalk Robotics Source Type: news
7 medtech stories we missed this week: June 2, 2017
[Photo from unsplash.com]From Implandata receiving CE Marking to Inolife eyeing up-listing, here are 7 medtech stories we missed this week but thought were still worth mentioning.
1. Dextera seeks expanded indications for MicroCutter 5/80 stapler
Dextera Surgical announced in a June 1 press release that it has filed a 510(k) with the FDA for its MicroCutter 5/80 stapler. The company wants to expand the indications of the MicroCutter 5/80 for use in liver, pancreas, kidney and spleen surgeries. Currently, the staplers are used for transection and resection in multiple open minimally-invasive urologic, thoracic and pediatr...
Source: Mass Device - June 2, 2017 Category: Medical Devices Authors: Danielle Kirsh Tags: Business/Financial News Clinical Trials News Well Regulatory/Compliance Research & Development c2 Therapeutics Dextera Surgical DreaMed Diabetes EndoGastric Solutions Inc. Implandata Inolife MicroTransponder Inc. Source Type: news
ESOC 2017 Roundup: Gore touts lowered ischemic stroke, new brain infarcts in PFO Occluder test
W.L. Gore & Associates yesterday released results from the Reduce study of its Cardioform Septal Occluder devices used to close patent foramen ovale, touting a reduction in recurrent ischemic strokes and new brain infarcts.
The Gore Cardioform Septal Occluder is designed to be inserted via catheter and is currently cleared by the FDA for closure of atrial septal defects.
“It is of the utmost importance to us to be transparent and share clinical data as quickly as possible. We completed our two-year primary endpoint follow-up with patients in March and have worked diligently to release these important data to the ...
Source: Mass Device - May 17, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Catheters Clinical Trials Stryker W.L. Gore & Associates Source Type: news
Medtronic touts Solitaire stent retriever data
Medtronic (NYSE:MDT) yesterday touted data presented at the International Stroke Conference on its Solitaire stent retriever from 4 studies. The Solitaire stent retriever uses a micro-sized catheter to access arteries in the brain, restoring blood flow and removing blood clots that cause acute ischemic stroke.
The Stratis AIS study evaluated the impact of treatment delays and patient outcomes when patients were treated with the Solitaire stent retriever and intravenous tissue plasminogen activator. Of the 984 enrolled patients, 64% were treated with the device and IV-tPA, while 36% were treated with the stent retriever al...
Source: Mass Device - February 24, 2017 Category: Medical Equipment Authors: Sarah Faulkner Tags: Clinical Trials Neurological Wall Street Beat Medtronic Source Type: news
Stryker ’ s Concentric Medical wins Class II FDA label for Trevo clot retrieval devices
The FDA today announced it has relabelled Stryker (NYSE:SYK) subsidiary Concentric Medical‘s Trevo mechanical thrombectomy devices as Class II.
Concentric Medical submitted a request for reclassification of the Trevo ProVe and XP ProVue retrievers in October last year, according to the FDA.
The federal watchdog reviewed the order, and said that on September 2 it issued an order to reclassify the device types, given the generic name of neurovascular mechanical thrombectomy devices for ischemic stroke treatment, as Class II.
In relabeling the devices, the FDA identified 5 possible risks, including adverse tissue rea...
Source: Mass Device - December 27, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Food & Drug Administration (FDA) Regulatory/Compliance Vascular Concentric Medical Inc. Stryker Source Type: news
FDA expands indication for Medtronic ’ s Solitaire stent retriever
Medtronic (NYSE:MDT) said today that the FDA granted 510(k) clearance for an expanded indication for its Solitaire stent retriever.
The new indication covers its use as an initial treatment for acute ischemic stroke after the administration of intravenous tissue plasminogen activator and within six hours of symptom onset, Fridley, Minn.-based Medtronic said. The Solitaire device is designed to remove clots from brain arteries using a micro-sized catheter.
“This expanded indication for the Solitaire device demonstrates Medtronic’s ongoing dedication to significantly improving the lives of stroke patients,”...
Source: Mass Device - November 16, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Regulatory/Compliance Medtronic Stroke Source Type: news
