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Source: Mass Device
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Total 467 results found since Jan 2013.
Japan approves iSchemaView ’ s Rapid stroke imaging device
iSchemaView today announced that it received registration approval in Japan for its Rapid imaging platform.
The company received registration approval through the Japanese Pharmaceutical Affairs Law and through a third party review by the Japanese Assn. for the Advancement of Medical Equipment for the Rapid imaging platform.
Rapid is designed to give physicians a fast, fully automated and easy-to-interpret imaging system that can help doctors make clinical decisions about stroke.
“Stroke remains the fourth most common cause of death in Japan, and as the population ages, stroke is likely to become an increasing health...
Source: Mass Device - July 8, 2019 Category: Medical Devices Authors: Danielle Kirsh Tags: Cardiovascular Hospital Care Imaging ischemaview Source Type: news
Medtronic touts stroke data from HeartWare HVAD thoracotomy study
Medtronic (NYSE:MDT) today touted stroke data from the Lateral trial of its HeartWare HVAD left ventricular assist device involving implantation via thoracotomy instead of open surgery.
With a thoracotomy implantation, surgeons insert the pump via a small, lateral incision between the left ribs and make a second small incision to accommodate the pump’s outflow graft. Fridley, Minn.-based Medtronic said Lateral results presented at the annual meeting of the American Society for Artificial Internal Organs showed that 95% of thoractomy patients were free from disabling stroke at two years.
Adverse events were more like...
Source: Mass Device - July 8, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Cardiac Assist Devices Cardiovascular Clinical Trials Featured Medtronic Source Type: news
Penumbra VR device wins FDA clearance
Penumbra recently announced that it has received FDA 510(k) clearance for its Real Immersive virtual reality system.
The Real Immersive System is an immersive virtual reality and display system that tracks upper extremity rehabilitation exercises for adults who have symptoms related to acute pain, cerebral palsy, stroke, orthopedic or neurodegenerative diseases. The exercise routines with the Real Immersive System are designed to be done in a seated position in a clinical environment, according to Penumbra.
The system features a clinician tablet, head-mounted display component, small sensors, large sensor, sensor charger,...
Source: Mass Device - April 15, 2019 Category: Medical Devices Authors: Danielle Kirsh Tags: 510(k) Regulatory/Compliance Penumbra Inc. Source Type: news
Conformal Medical launches LAA seal study
Conformal Medical said yesterday that it launched an investigational device exemption trial for a device designed to seal off the heart’s left atrial appendage to help prevent stroke in atrial fibrillation patients.
Nashua, N.H.-based Conformal’s device is designed to adapt to the each patient’s individual physiology, to be easier to implant with less imaging and without general anesthesia. The 45-patient, single-arm study is designed to evaluate the device’s performance, with an estimated primary completion date of April 2020 and a final completion date of June 2025, according to ClinicalTrials.gov.
Th...
Source: Mass Device - April 10, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Cardiac Implants Clinical Trials Featured Conformal Medical Source Type: news
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
Medtronic touts stroke data for HeartWare LVAD
A retrospective analysis of two studies involved the HeartWare left-ventricular assist device Medtronic (NYSE:MDT) acquired in 2016 showed that managing blood pressure reduced the severity of strokes in patients implanted with the HVAD pump.
The analysis, of “destination therapy” patients who are not candidates for a heart transplant, took data from the Endurance and Endurance Supplemental studies. Results were presented this week at the annual meeting of the International Society for Heart & Lung Transplantation in London, Medtronic said.
The 465-patient Endurance Supplemental study compared 308 patients i...
Source: Mass Device - April 5, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Cardiac Assist Devices Clinical Trials Featured Abbott HeartWare International Inc. Medtronic stjudemedical Thoratec Corp. Source Type: news
UPDATE: Silk Road Medical prices $120m IPO
Updated to include comment from CEO Erica Rogers
Silk Road Medical late yesterday priced its initial public offering, looking to raise approximately $120 million.
The Sunnyvale, Calif.-based company said it plans to float 6 million shares of its common stock at a price of $20 per share. The offering also includes a 30-day underwriters option to purchase an additional 900,000 shares of common stock.
Silk Road Medical produces the Enroute transcarotid neuroprotection and stent system, which is intended for use during the transcarotid artery revascularization procedure, or TCAR.
“The Enroute system is part of the devic...
Source: Mass Device - April 4, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Featured Vascular Wall Street Beat Silk Road Medical Inc. Source Type: news
Silk Road Medical upsizes IPO
Silk Road Medical today boosted the size of its pending initial public offering to as much as $120 million.
When it registered the IPO in March, Silk Road said it could fetch as much as $86 million. But last week the Sunnyvale, Calif.-based company cut the range, saying it planned to float nearly 4.7 million shares at $15 to $17 apiece, for gross proceeds of $70.5 million to $79.9 million.
Today Silk Road said it plans to offer 6 million shares at $19 to $20 a piece, which would deliver gross proceeds of $114 million to $120 million. The company developed the Enroute transcarotid stent and neuroprotection system to treat c...
Source: Mass Device - April 3, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Featured Funding Roundup Neurological Wall Street Beat Silk Road Medical Inc. Source Type: news
Silk Road Medical sets downsized range for IPO
Silk Road Medical yesterday set the range on its forthcoming initial public offering, which would fetch $75 million at the midpoint.
The Sunnyvale, Calif.-based company’s Enroute transcarotid stent and neuroprotection system is designed to treat carotid artery blockages before they cause a stroke. When it registered the IPO earlier this month, Silk Road said it could fetch as much as $86 million. But yesterday the company said it plans to float nearly 4.7 million shares at $15 to $17 apiece, for gross proceeds of $70.5 million to $79.9 million.
Silk Road has said it plans to use the cash to expand its sales force and ope...
Source: Mass Device - March 26, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Cardiovascular Featured Funding Roundup Wall Street Beat Silk Road Medical Inc. Source Type: news
Omron wins FDA nod for combined blood pressure monitor, EKG
Omron Healthcare (TYO:6645) has won FDA 510(k) clearance for its Blood Pressure Monitor + Echocardiogram device, according to a recently posted FDA release.
The device, which was developed in collaboration with AliveCor, allows users to monitor both high blood pressure and atrial fibrillation, which the company said are critical risk factors for stroke.
The newly cleared device is designed to sync with the Omron Connect mobile application to store, track and share heart health data with physicians to improve outcomes, the company said in its original product release.
The combined product, under the moniker BP7900, was cle...
Source: Mass Device - March 25, 2019 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Diagnostics Food & Drug Administration (FDA) Regulatory/Compliance AliveCor Omron Source Type: news
ACC 2019: Abbott touts reduced stroke, bleeding and pump-clotting in HeartMate 3 trial
Abbott (NYSE:ABT) yesterday presented data from a new trial of its HeartMate 3 left ventricular assist device, touting a reduced rate of strokes, pump-related blood clots and bleeding episodes at two years as compared with the previous generation HeartMate II.
Data in the trial was presented at the American College of Cardiology’s 68th Annual Scientific Session 2019 in New Orleans and published simultaneously in the New England Journal of Medicine, the Chicago-area medical device company said.
Abbott touted its HeartMate 3 as the first implantable mechanical pump using fully magnetic levitation technology, making it fri...
Source: Mass Device - March 18, 2019 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Featured Abbott Source Type: news
ACC 2019: Medtronic, Edwards low-risk TAVR trial data could pave way to new indications
Results from trials of both Medtronic‘s (NYSE:MDT) and Edwards Lifesciences‘ (NYSE:EW) transcatheter aortic valve replacement systems exploring their use in low-risk patients indicated that the devices were as safe as open surgery, paving the way for possible new indications for TAVR technology.
Data from the trials were presented over the weekend at the American College of Cardiology 68th Annual Scientific Session 2019 in New Orleans and simultaneously published in the New England Journal of Medicine.
Currently, TAVR devices are only approved by the FDA for treating severe aortic valve stenosis in patients at inte...
Source: Mass Device - March 18, 2019 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Featured Replacement Heart Valves Edwards Lifesciences Medtronic Source Type: news
Report: Boston Scientific looks to lure Irish expats from Australia to fill its roster
In an effort to fill open positions at its Galway, Ireland-based facilities, Boston Scientific (NYSE:BSX) is offering to cover relocation costs for expatriated residents that left for positions in Australia, according to a Connacht Tribune report.
The residents left Galway for Australia during the recent recession, according to the report, leaving a shortage of skilled workers in Ireland.
Due to the shortage, the Marlborough, Mass.-based company has begun head hunting in Australia, looking for senior quality and manufacturing engineers and to fill R&D roles, according to the Connacht Tribune.
Boston Scientific is look...
Source: Mass Device - March 15, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Boston Scientific Source Type: news
Corindus Vascular Robotics meets The Street with Q4 earnings
Corindus Vascular Robotics (OTC:CVRS) shares gained today after the robot-assisted surgery company reported fourth-quarter results that met the forecast on Wall Street.
Losses grew 3.1% for Waltham, Mass.-based Corindus posted to -$8.2 million, or -4¢ per share, on sales growth of 11.5% to $4.7 million for the three months ended Dec. 31, 2018, compared with the same period in 2017. Analysts were looking for LPS of -4¢.
Full-year losses were ip 25.0% to -$42.6 million, or -22¢ per share, on sales growth of 11.7% to $10.8 million compared with 2017.
“2019 is poised to be another significant year for Corindus. The succes...
Source: Mass Device - March 13, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Cardiovascular MassDevice Earnings Roundup Robotics Wall Street Beat Corindus Vascular Robotics Source Type: news
Boston Scientific wins CE Mark for Watchman FLX anti-stroke implant
Boston Scientific (NYSE:BSX) said today that it won CE Mark approval in the European Union for the next iteration of its Watchman anti-stroke heart implant.
The Marlborough, Mass.-based medical device maker said the Watchman FLX is designed to be easier to implant during procedures to occlude the left atrial appendage and is re-capturable and re-positionable intraprocedurally.
Watchman FLX is under limited release in Europe, with more sites slated to come on line during the second half of the year, Boston Scientific said. A European post-market registry study is also planned, the company said.
“The Watchman device h...
Source: Mass Device - March 13, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Cardiac Implants Featured Wall Street Beat Boston Scientific Stroke Source Type: news
