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Source: Mass Device
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Total 467 results found since Jan 2013.
Penumbra: Stroke study shows aspiration system equal to stent retrievers
Penumbra (NYSE:PEN) touted data from the Aster trial evaluating its aspiration system compared to a stent retriever as a first-line thrombectomy approach for acute ischemic stroke.
The data showed that the company’s direct aspiration, first-pass technique (Adapt) compared favorably with a stent retriever – 85.4% of patients treated with Penumbra’s aspiration system met the study’s revascularization primary endpoint, compared to 83.1% of their counterparts treated with stent retrievers.
“The Aster study provides evidence that starting with Penumbra aspiration first as part of the Adapt techniqu...
Source: Mass Device - February 22, 2017 Category: Medical Equipment Authors: Sarah Faulkner Tags: Clinical Trials Vascular Wall Street Beat Penumbra Inc. Source Type: news
Boston Scientific touts no deaths, low PVL rates in Lotus TAVR trial
Boston Scientific (NYSE:BSX) this week presented new data from the Respond extension study of its Lotus transcatheter aortic valve replacement with its Depth Guard technology, touting no deaths and low rates of paravalvular regurgitation.
Data from the study was presented at the Cardiovascular Research Technologies CRT 2017 annual meeting in Washington D.C.
The 50-patient Respond Extension study aimed to assess clinical and device performance outcomes with its Lotus Valve in combination with the Depth Guard technology.
The Marlborough, Mass.-based company’s Depth Guard tech is designed to optimize valve deployment by an...
Source: Mass Device - February 21, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Replacement Heart Valves Boston Scientific Source Type: news
SentreHeart logs German reimbursement win for Lariat, Eclipse LAA closure devices
SentreHeart said today that the German Institute for the Hospital Remuneration System granted renewed Status 1 to its Lariat and Eclipse left atrial appendage closure devices.
The coverage will allow 50 hospitals under the NUB1 innovation program to negotiate for reimbursement to cover costs for treating patients with the Lariat for LAAC when such a procedure is a suitable alternative to anticoagulation. The decision is valid for 1 year and can be renewed by application, the Redwood City, Calif.-based company said.
“We are very pleased with the NUB renewal and the robust number of applications for 2017. This is vali...
Source: Mass Device - February 10, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Cardiovascular SentreHeart Source Type: news
Neural Analytics wins CE Mark for next-gen Lucid transcranial ultrasound
Neural Analytics said today it won CE Mark approval in the European Union for its next-gen Lucid M1 transcranial doppler ultrasound system.
The Los Angeles-based company’s Lucid M1 is a portable all-in-one ultrasound system designed for rapid triaging and monitoring of patients with brain disorders.
“The development of accurate and portable brain monitoring technology like the Lucid System is critical to expanding brain care in the 21st century. Healthcare professionals will be able to utilize this diagnostic tool in a variety of clinical settings to accurately measure the brain’s blood flow to expedite medic...
Source: Mass Device - January 25, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Imaging Neurological Regulatory/Compliance Neural Analytics Source Type: news
Layoffs ahead for ReWalk Robotics
ReWalk Robotics (NSDQ:RWLK) is reportedly planning to cut its operating expenses by 30% in 2017, a move that’s slated to include layoffs for an unspecified number of workers.
The Marlborough, Mass.- and Israel-based company said it aims to meet its goal partially via a “reduction in staffing.” ReWalk had 87 employees as of December 2015, according to a regulator filing.
“In the years since ReWalk received its FDA clearances for spinal cord-injured individuals, we have seen the market evolve, albeit slowly,” CEO Larry Jasinski said in prepared remarks. “Taking an industry-wide assessme...
Source: Mass Device - January 11, 2017 Category: Medical Equipment Authors: Sarah Faulkner Tags: Prosthetics Robotics Wall Street Beat ReWalk Robotics Source Type: news
Stryker gains on Q4 prelims
Stryker (NYSE:SYK) shares are up after the orthopedics and hospital equipment giant posted preliminary financial results for the 4th quarter that narrowly beat the consensus forecast on Wall Street.
The Kalamazoo, Mich.-based company said it expects a total revenue of $3.2 billion for Q4, up 16.3% from the same time last year. Analysts were looking for sales of $3.15 billion.
“I am pleased with our performance in both the 4th quarter and the full year 2016,” chairman & CEO Kevin Lobo said in prepared remarks. “Fourth-quarter organic growth of 6.7% versus a strong prior year is impressive, and was ba...
Source: Mass Device - January 11, 2017 Category: Medical Equipment Authors: Sarah Faulkner Tags: Robot-Assisted Surgery Vascular Wall Street Beat Concentric Medical Inc. Stryker Source Type: news
Nico launches trial for brain surgery shunt
Nico Corp said today it enrolled the 1st patient in the Enrich clinical trial which aims to explore the use of its BrainPath Approach for treating intracerebral hemorrhages.
The trial will examine the procedural safety as well as economic and functional benefit of early surgical removal of intracerebral hemorrhages using its BrainPath Approach system.
“Our initial clinical results with this approach for early clot removal have been exciting and provided a wake-up call to what has been missing in hemorrhagic stroke care,” trial principal investigator Dr. Daniel Barrow said in a press release.
Indianapolis, I...
Source: Mass Device - January 10, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Clinical Trials Neurological Nico Corp. Source Type: news
Amnis launches 1st-in-human study of Golden Retriever thrombectomy device
Israeli vascular-focused bio-engineering company Amnis Therapeutics said today it won Swedish approval for a 1st-in-human clinical trial of its Golden Retriever neuro thrombectomy device.
The trial will be led by neurosurgeon Dr. Tommy Andersson, and is slated to enroll 60 acute ischemic stroke patients with large intracerebral vessel occlusion, the company said.
“We are happy to start the clinical phase of testing the Golden Retriever, which is the last phase, prior to receiving a CE Mark. We believe that the Golden Retriever’s attributes, suggest significant advantages over existing products for neuro throbem...
Source: Mass Device - January 3, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Clinical Trials Regulatory/Compliance Vascular Amnis Therapeutics Source Type: news
Stealthy NeuroVasc Technologies raises $1m
Stealthy NeuroVasc Technologies said yesterday that it raised a $1 million funding round, taking it’s total raise since last year to nearly $2.5 million.
Laguna Hills, Calif.-based NeuroVasc is led by CEO Ev3 veteran Jianlu Ma, according to regulatory filings. According to the LinkedIn page of chairman Jeff Peters, the former Anulex Technologies CEO who’s also an Ev3 alum, NeuroVascular Technologies is developing an interventional neuroradiology technology to treat ischemic stroke.
The $1 million round included 3 unnamed investors, according to 1 of the filings. NeuroVascular Technologies reported raising $1...
Source: Mass Device - December 30, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Funding Roundup Neurological Vascular Wall Street Beat NeuroVasc Technologies 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
J & J ’ s Codman Neuro picks up Pulsar Vascular
Johnson & Johnson‘s (NYSE:JNJ) Codman Neuro said last week it picked up Pulsar Vascular, which produces the PulseRider device for treating brain aneurysms, for an undisclosed amount.
The PulseRider is designed to shore up the blood vessels around wide-necked aneurysms at or near a bifurcation of the basilar tip or carotid terminus and facilitate the implantation of an embolization coil, without obstructing blood flow through the vessels, according to the company’s website.
Codman Neuro said the acquisition will complement its portfolio of products covering hemorrhagic and ischemic stroke.
“There is a signif...
Source: Mass Device - December 13, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Mergers & Acquisitions Vascular Codman Neuro Johnson and Johnson Pulsar Vascular Source Type: news
Silk Road touts low stroke rate in 2 studies of Enroute TCAR system
Silk Road Medical yesterday released data from 2 studies of its Enroute transcarotid neuroprotection and stent system, including 1-year data from a pivotal trial of the device and an interim analysis of a post-approval study of the Enroute.
Data from the studies was presented last month at the 44th annual Veith Symposium in New York.
The Sunnyvale, Calif.-based company touts the Enroute system and stent as the 1st and only devices currently approved for transcarotid artery revascularization procedures by the FDA.
Silk Road presented data from the Roadster 1 pivotal trial of the TCAR system, which examined the use of ...
Source: Mass Device - December 13, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Clinical Trials Vascular Silk Road Medical Inc. Source Type: news
Verily launches Liftware smart utensils
Verily Life Sciences, the healthcare play owned by Google parent Alphabet (NSDQ:GOOGL), said this week it launched the Liftware Level smart utensil designed to aid individuals with limited hand or arm mobility.
The Liftware Level is designed to help individuals who have hand and arm mobility issues, including those with cerebral palsy, spinal cord injuries, Huntington’s disease or post-stroke deficits.
The device operates by constantly monitoring the position of the hand, based on the handle, and intelligently adjusting the angle of the utensil, either a spoon or fork, so the user can eat without the contents s...
Source: Mass Device - December 8, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Verily Source Type: news
MassDevice.com +5 | The top 5 medtech stories for December 6, 2016
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. MedyMatch looks to future of stroke detection with AI platform launch
Artificial intelligence healthcare startup MedyMatch Technology said late last month its AI platform designed to detect intracranial hemorrhage or brain blee...
Source: Mass Device - December 6, 2016 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news
MedyMatch looks to future of stroke detection with AI platform launch
Artificial intelligence healthcare startup MedyMatch Technology said late last month its AI platform designed to detect intracranial hemorrhage or brain bleeds is now available for research.
The development is a milestone for the company, but is only the 1st stop for the platform, CEO Gene Saragnese told MassDevice.com in an interview.
“What we’ve done at MedyMatch is develop not just an algorithm, but an AI platform which looks at the entire patient – that is to say, the full richness of 3D imaging plus other patient attributes – to allow us, firstly, to understand whether that person is hemorrhagic st...
Source: Mass Device - December 5, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Imaging Software / IT MedyMatch Source Type: news
