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Source: Mass Device
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Total 467 results found since Jan 2013.
NIH inks $5m partnership with PathMaker Neurosystems for MyoRegulator spasticity device
PathMaker Neurosystems said today it signed a $5 million cooperative partnership deal with the National Institutes of Health to support continued development of its MyoRegulator neurostimulation system designed to treat spasticity secondary to stroke.
The MyoRegulator device, based on PathMaker’s DoubleStim technology, is designed to provide simultaneous, non-invasive stimulation at spinal and peripheral locations, the Boston and Paris-based company said.
The money comes as part of a four-year grant awarded through the CREATE Devices program which also provides a partnership with the NIH’s National Institute of ...
Source: Mass Device - February 7, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Neuromodulation/Neurostimulation PathMaker Neurosystems Inc. 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
ACC ’ 18 Roundup: Abbott releases long-term HeartMate 3 data
Abbott (NYSE:ABT) touted two-year data yesterday from its trial designed to compare the company’s HeartMate 3 left ventricular assist device to its HeartMate 2 device in patients with advanced heart failure.
Data from the study were published in The New England Journal of Medicine and presented at the American College of Cardiology’s 67th Annual Scientific Session.
More than 1,000 patients participated in the study. Researchers assessed the trial’s participants for a short-term endpoint of six months and long-term endpoint of two years.
The two-year cohort met its primary endpoint, achieving 77.9% event...
Source: Mass Device - March 12, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Cardiac Assist Devices Cardiac Implants Cardiovascular Clinical Trials Diagnostics Food & Drug Administration (FDA) Regulatory/Compliance Research & Development Wall Street Beat Abbott Aetna AliveCor iRhythm Technologies Inc. Jan Source Type: news
HRS 2018: Device-related blood clots with Boston Scientific ’ s Watchman implant
Data from a study of device-related blood clots and the Watchman cardiac implant made by Boston Scientific (NYSE:BSX), presented today at the annual meeting of the Heart Rhythm Society in Boston, indicate the need for aggressive management of patients at risk for device-related thrombosis.
There were 74 incidences of DRT in 65 of the 1,739 Watchman patients examined in the study, or 3.7%; eight of those patients had multiple DRTs and two experienced embolic events (0.45%). There was no significant difference in mortality between patients with DRT and those without, according to the study.
Lead author Dr. Vivek Reddy, of N...
Source: Mass Device - May 11, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Cardiovascular Boston Scientific HRS 2018 Source Type: news
HRS 2018 Roundup: Device-related blood clots with Boston Scientific ’ s Watchman implant
Data from a study of device-related blood clots and the Watchman cardiac implant made by Boston Scientific (NYSE:BSX), presented today at the annual meeting of the Heart Rhythm Society in Boston, indicate the need for aggressive management of patients at risk for device-related thrombosis.
There were 74 incidences of DRT in 65 of the 1,739 Watchman patients examined in the study, or 3.7%; eight of those patients had multiple DRTs and two experienced embolic events (0.45%). There was no significant difference in mortality between patients with DRT and those without, according to the study.
Lead author Dr. Vivek Reddy, of N...
Source: Mass Device - May 11, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Cardiovascular Apple Bardy Diagnostics Boston Scientific Fitbit HRS 2018 Impulse Dynamics Imricor Medical Systems Inc. medicalgorithmics Medtronic Preventice samsung Source Type: news
FDA warns on stents associated with stent-assisted neurovascular coiling procedures
The FDA today warned about risks associated with the use of neurovascular stents used in stent-assisted coiling procedures after receiving a number of reports that suggest possible associations between peri-procedural stroke or death with the use of the devices.
The federal watchdog warned of procedural risks or patient selection related health factors associated with the use of the neurovascular stents, including the use of such devices with patients who have serious co-morbidities which can result in reduced life expectancy, or patients who are intolerant to required anti-coagulant or anti-platelet therapy.
To avoid even...
Source: Mass Device - May 14, 2018 Category: Medical Devices Authors: Fink Densford Tags: Food & Drug Administration (FDA) Neurological Stents Vascular Source Type: news
Medtronic recalls select MindFrame Capture revascularization devices
The FDA today released a recall notice for a select number of Medtronic (NYSE:MDT) MindFrame Capture LP revascularization devices over issues with the delivery wire breaking or separating during use.
The federal watchdog labeled the recall as a Class I, its most serious class of recall, which indicates the potential for serious injury or death.
The Fridley, Minn.-based company’s MindFrame Capture LP device is designed to restore blood flow and remove blood clots within a blood vessel in the brain during acute ischemic stroke in patients who are ineligible or fail intravenous tissue plasminogen activator therapy.
Medtroni...
Source: Mass Device - May 21, 2018 Category: Medical Devices Authors: Fink Densford Tags: Food & Drug Administration (FDA) Neurological Recalls Vascular Medtronic 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
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
Boston Scientific closes $270m Claret Medical buy
Boston Scientific (NYSE:BSX) said yesterday that it closed the $270 million buyout of Claret Medical and its Sentinel device, including a $50 million earnout pegged to a reimbursement win that just came in.
Claret’s Sentinel device is designed to trap and remove debris dislodged during transcatheter aortic valve replacements to prevent stroke and other neurological damage. The deal, announced July 20, originally called for an up-front cash payment of $220 million plus the $50 million reimbursement milestone.
That milestone was reached when the Centers for Medicare & Medicaid Services granted a New Technology Add...
Source: Mass Device - August 3, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Mergers & Acquisitions Replacement Heart Valves Wall Street Beat Boston Scientific Claret Medical Inc. Source Type: news
FDA clears Contego Medical ’ s Paladin carotid balloon
Contego Medical said today that it won 510(k) clearance from the FDA for its Paladin carotid balloon with embolic protection.
Raleigh, N.C.-based Contego said the Paladin device consists of an angioplasty balloon and a 40-micron filter for carotid stenting procedures. It won CE Mark approval in 2015 in the European Union, where it launched the following January.
A post-market surveillance study of 106 patients showed a 0.9% risk of death, stroke and myocardial infarction at 30 days and zero procedural strokes, the company said.
“We are thrilled to have achieved this milestone for the first of several devices Conteg...
Source: Mass Device - September 18, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Cardiovascular Featured Food & Drug Administration (FDA) Contego Medical Source Type: news
FDA approves Abbott ’ s HeartMate 3 as a destination therapy
Abbott (NYSE:ABT) said today it won FDA approval for its HeartMate 3 left ventricular assist device, now approved as a destination therapy for patients with advanced heart failure.
With the approval, the Chicago-based company said that the device can now be used in patients not eligible for a transplant as a life-long implant.
“We partner with physicians to holistically develop therapies that benefit patients and achieve better outcomes. The unique design of the HeartMate 3 LVAD—with its Full MagLev technology—takes an established innovation and improves upon it in meaningful ways to help people with advanced he...
Source: Mass Device - October 19, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance Abbott Source Type: news
Medtronic to pay $51m to settle Covidien, ev3 DoJ investigations
Medtronic (NYSE:MDT) said yesterday that it agreed to pay $50.9 million to settle a number of U.S. Dept. of Justice probes into marketing activities from companies it acquired, Covidien and ev3.
Medtronic said that its subsidiary ev3, acquired when the Fridley, Minn.-based medtech giant picked up Covidien in 2015, agreed to plead guilty to a misdemeanor charge related to its marketing of the Onyx Liquid Embolic System, pay $17.9 million and adopt new compliance and reporting terms for three years.
The charges relate to ev3’s marketing of the device for “unproven and potentially dangerous uses,” federal prose...
Source: Mass Device - December 5, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Featured Legal News Medtronic Source Type: news
Korean JLK Inspection launches AI-powered imaging diag system
Korean JLK Inspection said yesterday that it launched its AIHub artificial intelligence-powered medical image diagnostics platform.
The newly launched AIHub system is designed to analyze images from a number of different imaging modalities, including magnetic resonance imaging, computed tomography, X-ray and mammography, the Seoul-based company said.
JLK Inspection claims the system can detect and monitor for more than 30 medical conditions in 14 regions of the body. The company added that the system is focused on brain diseases and conditions including ischemic stroke, hemorrhagic stroke, brain aneurysm and Alzheimer̵...
Source: Mass Device - December 27, 2018 Category: Medical Devices Authors: Fink Densford Tags: Diagnostics Imaging Software / IT jlkinspection 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
