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MassDevice.com +5 | The top 5 medtech stories for June 5, 2017
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. Get this in your inbox everyday by subscribing to our newsletters.   5. SentreHeart enters pivotal phase after hitting Lariat study milestone SentreHeart can launch the 2nd, pivotal phase in the Amaze study of its Lariat device, after hitting the mark in the 1st, 100-patient stage. Like the Watchma...
Source: Mass Device - June 5, 2017 Category: Medical Devices Authors: MassDevice Tags: News Well Plus 5 Source Type: news

SentreHeart enters pivotal phase after hitting Lariat study milestone
SentreHeart can launch the 2nd, pivotal phase in the Amaze study of its Lariat device, after hitting the mark in the 1st, 100-patient stage. Like the Watchman anti-stroke device made by Boston Scientific (NYSE:BSX), Lariat is designed to occlude the left atrial appendage, but unlike Watchman it’s intended to help treat atrial fibrillation alongside pulmonary vein isolation. The FDA approved an expansion of the study, which can now enroll another 500 patients after an independent data monitoring committee reviewed the data against preset safety and performance criteria, Redwood City, Calif.-based SentreHeart said....
Source: Mass Device - June 5, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Cardiovascular Clinical Trials Food & Drug Administration (FDA) Cardiac Rhythm Management SentreHeart 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

Finland extends due date on Nexstim R & D loans
Nexstim said today that the Finnish Funding Agency for Innovation has agreed to extend the due date for repayment of 2 of its research & development project loans. According to the agreement, the company was supposed to provide cash repayments up to €1.8 million ($2 million) between 2017 and 2019. Now, that range has been pushed back to between 2020 and 2022. The company has to fully repay both loans to Tekes by the end of 2023, Nexstim said. “This agreement, which reschedules our R&D loan repayment payments to Tekes, will have a positive effect on Nexstim’s cash flow and will help to support our workin...
Source: Mass Device - June 2, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Funding Roundup Neurological Wall Street Beat Nexstim Source Type: news

6 brain-controlled devices helping people regain movement
[Image from Amy Leonard on Flickr]People who have lost feeling in their limbs or have lost the ability to move them may soon have those sensations restored thanks to a slew of recent brain-controlled device innovations. While we are moving toward less invasive methods like electrode-filled caps on the head, there are still more invasive implants that are benefiting those who suffered from a stroke or a serious spinal cord injury. From mind-controlled exoskeletons to robots reading your mind, here are 6 brain-controlled devices that are moving robotic arms and helping people become mobile again. Next >> The post 6 bra...
Source: Mass Device - June 2, 2017 Category: Medical Devices Authors: Danielle Kirsh Tags: Neurological Neuromodulation/Neurostimulation Prosthetics Robotics Boston University EEG mit Neuolutions Ohio State University paralysis University of Melbourne University of Minnesota University of Pittsburgh Source Type: news

Ex-Invacare chief Mixon pulls the trigger on convertible shares
Invacare (NYSE:IVC) said yesterday that the former chairman & CEO who rescued the company from the doldrums in the 1980s, Malachi Mixon III, is pulling the trigger on the more than 700,000 convertible shares he controls. The 1-for-1 exchange will take Invacare’s voting power from 40,155,366 votes to 33,820,158 votes, the Elyria, Ohio-based company said. “The conversion will substantially diminish the significance of the company’s dual class voting structure, as after completion, the holders of the common shares will represent approximately 99.5% of the company’s total outstanding voting power,...
Source: Mass Device - June 1, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Wall Street Beat Invacare Rehabilitation Equipment Source Type: news

Medical imaging AI dev Viz raises $8m in seed round
Medical imaging artificial intelligence company Viz said today it closed a $7.5 million seed round of financing to support the development of its AI platform. Viz is developing an AI-equipped medical imaging platform with an initial focus on stroke, looking to improve outcomes and treatment of stroke patients by shortening the time between seeking and receiving treatment. The company’s AI platform is being developed to compare patient scans to thousands of other scans to determine patterns within them, and aid in treatment accuracy and speed. “As doctors, there is nothing more important to us than improving pat...
Source: Mass Device - May 25, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Imaging Software / IT viz Source Type: news

Artificial intelligence accurately predicts stroke risk
[Image from unsplash.com]Machine-learning algorithms, a form of artificial intelligence, accurately predicted people’s risk of heart disease and stroke, according to new research from the University of Nottingham. Researchers and computer scientists compared the risk guidelines for heart disease and stroke from the American College of Cardiology with 4 machine-learning algorithms to analyze the risk of a patient having each. The results showed that the artificially intelligent algorithms were significantly more accurate at predicting cardiovascular disease than the regular medical models. Get the full story on our sister...
Source: Mass Device - May 25, 2017 Category: Medical Devices Authors: Danielle Kirsh Tags: Cardiovascular Research & Development AI artificial intelligence cardiovascular disease heart disease machine learning algorithms Stroke University of Nottingham Source Type: news

Neural Analytics touts 95% accuracy for TCD platform in Expedite trial
Neural Analytics today released initial results from the Expedite study of its Transcranial Doppler Tech platform, touting 95% accuracy in the early detection of acute ischemic stroke due to large vessel occlusion. Data from the study was presented at the 26th annual European Stroke Conference this week in Berlin. The 45-subject trial examined the use of TCD scans in patients experiencing computer tomography angiography confirmed acute ischemic stroke due to large vessel occlusion of the internal carotid artery or middle cerebral artery. Scans with the TCD platform were analyzed with 2 different stroke assessment algorith...
Source: Mass Device - May 24, 2017 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Diagnostics Neurological Ultrasound Neural Analytics Source Type: news

Anaconda Biomed raises $17m for next-gen brain thrombectomy device
Anaconda Biomed said it raised nearly $17 million (€15 million) in a Series A round for the neurothrombectomy device it’s developing. The round, led by new investors Ysios Capital, Omega Funds and Banco Sabadell and prior backer Innogest Capital, is enough to carry the ANCD Brain device through validation & verification and clinical studies ahead of a CE Mark bid in the European Union, co-founder & CEO Ofir Arad said in prepared remarks. The proceeds are also earmarked for an initial approval submission to the FDA, Arad said. Ysios general partner Josep Sanfeliu and Omega Funds managing director Claudio...
Source: Mass Device - May 23, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Catheters Funding Roundup Neurological Anaconda Biomed Source Type: news

MassDevice.com +5 | The top 5 medtech stories for May 19, 2017
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. Get this in your inbox everyday by subscribing to our newsletters.   5. The key components of a well-designed wearable: Sense, analyze, act One of the earliest uses of a wearable technology was recorded during Emperor Nero’s rule over the Roman Empire from 54 to 68 AD. A brutal leader, the empero...
Source: Mass Device - May 19, 2017 Category: Medical Devices Authors: MassDevice Tags: News Well Plus 5 Source Type: news

Slow enrollment delays Nexstim pivotal trial
Nexstim said today that slow enrollment in pivotal trial of its Navigated Brain Therapy transcranial magnetic stimulation device in treating patients rehabilitating from stroke. The 60-patient E-Fit study, launched in March, is designed to supplement Nexstim’s already complete Niche study. The Finnish company originally expected to conclude the E-Fit supplemental during the 1st quarter next year, but said today that “start-up issues” at some of the 5 U.S. sites “created a slight delay in the enrollment rate.” The E-Fit trial is now slated to be completed during the 2nd quarter of 2018, the ...
Source: Mass Device - May 19, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Clinical Trials Neuromodulation/Neurostimulation Nexstim Stroke 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

No-touch ’ heart bypass surgery reduces strokes
Four surgical methods of coronary artery bypass grafting with increasing degrees of aortic manipulation. Percentages pictured represent the relative decrease in risk of perioperative stroke using anOPCABG compared to the other techniques. [Image from the researchers]]A recent study from the University of Sydney and Sydney Heart and Lung Surgeons has shown that a new “no-touch” beating heart bypass surgery technique has reduced post-operative stroke by 78%. The procedure, known as an OPCABG, also reduced post-operative mortality by 50% compared to traditional coronary artery bypass grafting. It reduced renal failure by ...
Source: Mass Device - May 17, 2017 Category: Medical Devices Authors: Danielle Kirsh Tags: Cardiovascular CABG MedTech Sydney Heart and Lung Surgeons University of Sydney Source Type: news

EuroPCR 2017 Roundup: Boston Scientific ’ s Lotus beats Medtronic ’ s CoreValve in head-to-head study
Boston Scientific (NYSE:BSX) said its Lotus replacement heart valve beat the competing CoreValve device made by Medtronic (NYSE:MDT) in a head-to-head trial. Data from the Reprise III study, billed as the 1st head-to-head pivotal trial comparing transcatheter aortic valve replacements, were released today at the annual EuroPCR meeting in Paris. The 912-patient study compared Lotus with the CoreValve and CoreValve Evolut devices in high- and extreme-risk patients. The primary efficacy endpoint was the composite rate of death, disabling stroke and moderate or greater paravalvular leakage at 1 year; the primary safety endp...
Source: Mass Device - May 16, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Clinical Trials Replacement Heart Valves Wall Street Beat Boston Scientific Edwards Lifesciences europcr2017 Medtronic Source Type: news