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Source: Mass Device
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Total 467 results found since Jan 2013.
Paralyzed California man re-learns to walk via computer
(Reuters) — For paraplegic Adam Fritz, the thrill of the computer-assisted first steps he took five years after being paralyzed in a motorcycle crash came only after he was unhooked from the system that enabled him to walk briefly in a bioengineering lab.
During the experiment itself, Fritz recounted, he had to keep his mind focused entirely on placing one foot in front of the other as his brain waves were translated by a computer algorithm into impulses that bypassed his severed spinal cord and activated his legs.
“If you break your concentration, it wouldn’t work anymore,” he told Reuters shortly aft...
Source: Mass Device - September 24, 2015 Category: Medical Equipment Authors: MassDevice Tags: Research & Development Source Type: news
Medtronic touts CoreValve TAVR real-world registry data
Medtronic (NYSE:MDT) said today it released the 1st real-world registry study of its CoreValve transcatheter aortic valve replacement, reporting outcomes in-line with its clinical trials of the device.
The 6,160-patient Society of Thoracic Surgeons and American College of Cardiology TVT registry study reported a 5.2% rate of all-cause mortality and 2.6% rate of stroke at 30 days. Those rates are consistent with the 6.9% and 5% rates, respectively, from the pivotal trial, Fridley, Minn.-based Medtronic said.
“It is reassuring to see that the profound clinical results in the U.S. CoreValve Pivotal studies were replica...
Source: Mass Device - October 12, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Catheters Clinical Trials Medtronic Source Type: news
Procyrion’s Aortix device could heighten heart pump competition
Pay attention to Procyrion over the next several months. CEO Benjamin Hertzog tells MassDevice.com that the company plans on heading to the clinic with a device that could heighten competition among makers of cardiac assist devices.
The Houston-based startup plans to begin 1st-in-human trials of its Aortix catheter-based heart pump in the 1st half of 2016.
Other companies, most notably Abiomed (NSDQ:ABMD), are already in this space. St. Jude Medical (NYSE:STJ) is looking to enter the percutaneous pump market with the HeartMate PHP device it acquired in the $3 billion buyout of Thoratec earlier this fall. Abiomed ...
Source: Mass Device - October 22, 2015 Category: Medical Equipment Authors: Mark Hollmer Tags: Cardiac Assist Devices Abiomed Inc. Procyrion Source Type: news
UPDATE: Embolization coil maker Blockade Medical pulls in $2.2m
UPDATED Oct. 27, 2015, with comment from Blockade Medical.
Blockade Medical pulled in $2.2 million and is looking for another $5.8 million in a new round of equity financing, according to an SEC filing published today.
The round was joined by new investors TitanMed Capital and GP Healthcare Capital, as well as returning investors and other venture capital and private equity funds in the healthcare sector, Blockade Medical said.
Funds from the round will support commercialization efforts for the Barricade coil system, as well as the development of novel neurovascular devices to treat aneurysms, stroke and other conditions,...
Source: Mass Device - October 27, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Vascular Blockade Medical Source Type: news
Nipro to sell diagnostics biz to China’s Sinocare for $273m
Nipro (TYO: 8086) said today it signed a deal sell its diagnostics business to China-based Sinocare for approximately $273 in cash.
Nipro Diagnostics, based in Ft. Lauderdale, Fla., develops, manufactures and markets diabetes products, including glucose monitors, the company said.
“This transaction combines 1 of the fastest growing blood glucose monitoring companies in the United States with the fastest growing blood glucose monitoring company in China. We have a shared vision and a singular focus to provide innovative and affordable solutions so patients can live healthier lives. Together, we will offer a strong p...
Source: Mass Device - October 27, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Diabetes Diagnostics Mergers & Acquisitions Nipro Sinocare Source Type: news
PathMaker Neurosystems wins the fast track at FDA for MyoRegulator device
PathMaker Neurosystems said it won expedited access pathway designation from the FDA for its MyoRegulator PM-2200 system, which is designed to treat muscle spasticity.
The MyoRegulator device, based on PathMaker’s DoubleStim technology, is designed to provide simultaneous, non-invasive stimulation at spinal and peripheral locations, the Boston-based company said.
In June PathMaker inked a deal with Proven Process to develop and manufacture a device for treating patients with muscle tone disorders using trans-spinal direct current stimulation. The MyoRegulator device aims to treat muscle spasticity in patients with ...
Source: Mass Device - October 30, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Neuromodulation/Neurostimulation Regulatory/Compliance PathMaker Neurosystems Inc. Source Type: news
Boston Scientific touts Watchman study data
Boston Scientific (NYSE:BSX) yesterday presented data on its Watchman left atrial appendage occlusion device. The data was presented at the annual American Heart Association’s Scientific Sessions in Orlando, Fla.
The data comes from the Ewolution registry, the 1st real-world study of the Marlborough, Mass.-based company’s Watchman device.
The patient population of the study was the ‘highest risk patient population ever studied in a Watchman trial,” Boston Scientific said. A total 61.8% of the patient population were deemed contraindicated for oral anticoagulants.
The study reported the lowest peri-...
Source: Mass Device - November 10, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Blog Boston Scientific Source Type: news
Mercury Biomed wins $1.4m grant for thermal body tech
Newly formed medical temperature management company Mercury Biomed said Wednesday it won a $1.4 million loan from the Ohio Third Frontier Commercialization Acceleration Loan Fund for its Smart Temperature management system.
The company’s Smart Temperature management system work through applying heat along the back of the neck to send a signal to the body’s thermostat which responds by increasing blood flow on-demand, followed by water-circulating tubes that supply heat or cold to polymeric cooling pads at the hands and feet.
The device uses induced high blood flow between extremities and body cores to accelerat...
Source: Mass Device - December 4, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Mercury Biomed Source Type: news
EU OKs add’l delivery cath for InspireMD’s CGuard stent
InspireMD (OTC:NSPR) said Wednesday it won European Union regulatory approval, including CE Mark approval, for the manufacturing and commercialization of its CGuard stent delivery catheter.
The approval also allows InspireMD to add-on manufacturing facilities for the device to enable more efficient work flow, the Boston-based company said.
“We are pleased to receive Dekra certification for our enhanced CGuard delivery catheter, used when delivering the CGuard EPS into the carotid anatomy, supporting a more profitable and fluid scaling of our manufacturing operations. Our CGuard system continues to be well received ...
Source: Mass Device - December 4, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Catheters Regulatory/Compliance Stents InspireMD Source Type: news
Boston Scientific recalls Chariot sheaths; FDA labels it Class I
Boston Scientific (NYSE:BSX) said today it initiated a voluntary recall of its Chariot Guiding Sheaths designed to be used during peripheral vascular procedures due to the risk of shaft separation.
The FDA labeled the recall as a Class I, according to Boston Scientific. A Class 1 is the most serious type of recall issued by the federal watchdog, indicating “there is a reasonable probability that use of these products will cause serious adverse health consequences or death.”
Boston Scientific said it received 14 complaints over shaft separation issues, 4 of which involved separation of the distal shaft, all o...
Source: Mass Device - December 9, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Recalls Catheters Food & Drug Administration (FDA) Boston Scientific Source Type: news
J&J’s Ethicon loses $9.8m stapler suit
Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon lost a $9.8 million suit over injuries caused to a patient by a defective Ethicon PPH 03 hemorrhoid stapler.
The case was decided in the Alameda County Superior Court, according to the plaintiff’s counsel, the Alexander Law Group, LLP.
The plaintiff alleged that during surgery in January 2012, the defective staple misfired, sealing the patient’s anal canal shut and leading to 21 days of emergency hospitalization, massive infection and resulting abdominal surgeries including a full laparotomy and colostomy.
“This is a victory for all those who have been harmed by...
Source: Mass Device - December 11, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Legal News Business/Financial News Ethicon Endo-Surgery Johnson & Johnson Source Type: news
Medtronic, Germany’s Phenox to open new plants in Ireland
Medtronic (NYSE:MDT) and German medical device maker Phenox are each planning to open new manufacturing plants in Galway, Ireland.
Fridley, Minn.-based Medtronic said it plans to spend about $14.3 million (€13 million) building a new, 20,000-square-foot facility will be used to make its In.Pact Admiral drug-coated balloon. The plant is expected to employ about 100 workers, the company said.
“Since launching the In.Pact Admiral DCB in the U.S. market, it has quickly become the fastest adopted DCB technology. In fact, our global market leadership in DCB is driving the need to open the new facility here in Galway to...
Source: Mass Device - December 14, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Business/Financial News Medtronic phenox Source Type: news
Jury adds $70m in damages to $9.8m Ethicon stapler loss
A California state jury added $70 million in damages to the $9.8 million it awarded the plaintiff last week in a product liability lawsuit over Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon‘s PPH 03 hemorrhoid stapler, the plaintiff’s attorney’s said.
Plaintiff Florence Kuhlmann alleged that during hemorrhoidoplexy surgery in January 2012, the defective stapler misfired, sealing her anal canal and leading to 21 days of emergency hospitalization, infection and abdominal surgeries including a full laparotomy and colostomy, according to Alexander Law Group, her counsel in the case.
The jury in th...
Source: Mass Device - December 15, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Legal News Product Liability Ethicon Inc. Johnson & Johnson Source Type: news
HeartWare plunges on uncertainty around its next-gen MVAD pump
Shares of HeartWare International (NSDQ:HTWR) are down some 28% today after the implantable heart pump maker said it can’t predict when it will be able to get its next-generation MVAD program back on line.
Framingham, Mass.-based HeartWare said it expects to post sales of roughly $68 million for the 3 months ended Dec. 31, in line with the consensus forecast on Wall Street for $67.2 million. But the company said its still evaluating date from a CE Mark trial of the MVAD left ventricular assist device that was halted last fall, which it now says show evidence of blood clots in the pump. The incidence of pump thrombo...
Source: Mass Device - January 12, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiac Assist Devices Clinical Trials Wall Street Beat HeartWare International Inc. Source Type: news
