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Using wearable devices in clinical trials
Brandy Chittester, chief of clinical operations, IMARC Globally, more than 325 million people own wearable, connected devices, and more than 2.5 billion own smartphones. Using wearable devices in clinical trials can bring huge benefits, however, there are also concerns. Here’s a look at how researchers are using wearable devices — and what you should consider before using them in your own research. How wearable devices are advancing medicine Right now, ClinicalTrials.gov, a global database of clinical trials, lists nearly 200 trials with “wearable devices” or “wearable technology” in the description. This in...
Source: Mass Device - March 12, 2019 Category: Medical Devices Authors: Danielle Kirsh Tags: Blog IMARC Source Type: news

Sotera Wireless adds tools to patient monitoring system
Sotera Wireless said it has upgraded its ViSi Mobile patient monitoring system to detect atrial fibrillation, ventricular fibrillation and ventricular tachycardia, and to provide asystole analysis. Often asymptomatic, atrial fibrillation may remain undiagnosed until or even after the development of complications, such as stroke. Post-operative atrial fibrillation is the most common arrhythmia that occurs after both cardiac and noncardiac surgery and is associated with increased morbidity, longer hospital stays and higher hospital costs. ViSi Mobile was previously FDA-cleared to monitor continuous noninvasive blood pressure...
Source: Mass Device - March 6, 2019 Category: Medical Devices Authors: Nancy Crotti Tags: 510(k) Blog Food & Drug Administration (FDA) Health Information Technology mHealth (Mobile Health) News Well Patient Monitoring Regulatory/Compliance Sotera Wireless Source Type: news

Silk Road registers for $86m IPO
Silk Road Medical has registered for an initial public offering, looking to bring in approximately $86.3 million, according to a recently posted SEC filing. The Sunnyvale, Calif.-based company said that it applied to list its common stock on the NASDAQ exchange using the symbol “SILK,” according to the filing. The company’s flagship product is its Enroute transcarotid stent and neuroprotection system, which is designed to be used during a transcarotid artery revascularization procedure to treat blockages in the carotid artery that are at risk of causing a stroke. Funds from the offering will be used to ex...
Source: Mass Device - March 5, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Featured Initial Public Offering (IPO) Wall Street Beat Silk Road Medical Inc. Source Type: news

IschemaView launches Rapid Angio neuroimaging system
Medical imaging dev IschemaView said yesterday that it launched its Rapid Angio neuroimaging system designed for use in the angiography suite. The Menlo Park, Calif.-based company said that it partnered with Siemens (NYSE:SI) to integrate the Rapid software with Siemens’ SyngoDynaCT multiphase system for the newly launched imaging solution. Siemens’ SyngoDyna CT Multiphase is a 3D image acquisition technique which uses multiple rotations of a C-arm system to acquire multi-phasic 3D representation of the brain and its perfusion. “The Rapid Angio module, by combining the best-in-class syngoDynaCT system...
Source: Mass Device - March 1, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Imaging Neurological ischemaview Source Type: news

Study of Boston Scientific ’s Lotus, Medtronic’s CoreValve shows similar outcomes at 2 years
Two-year results from a head-to-head study comparing transcatheter aortic heart valve replacement devices from both Boston Scientific (NYSE:BSX) and Medtronic (NYSE:MDT) indicated similar outcomes for the competing products. The study, published recently in the journal JAMA Cardiology, compared Marlborough, Mass.-based Boston Scientific’s Lotus valve to Fridley, Minn.-based Medtronic’s CoreValve system. Investigators in the study compared outcomes for 912 patients with high or extreme risk and severe, symptomatic aortic stenosis after treatment with one of the two devices. Patients, treated between September 22, 2014...
Source: Mass Device - February 28, 2019 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Clinical Trials Featured Replacement Heart Valves Boston Scientific Medtronic Source Type: news

ReWalk Robotics files for exoskeleton suit clearance
  ReWalk Robotics’ exo-suit designed for stroke rehabilitation. ReWalk Robotics (NSDQ:RWLK) said it has applied to FDA for 510(k) clearance of its ReStore exoskeleton suit for gait training during stroke rehabilitation. The Yokneam, Israel-based company designed its exo-suit to provide coordinated plantarflexion and dorsiflexion assistance to a patient’s foot and ankle. It recently won insurer reimbursement from Cigna and completed a clinical trial involving 44 patients at five rehabilitation centers in the U.S. Get the full story on our sister site, Medical Design & Outsourcing. The post ReWalk Robotics file...
Source: Mass Device - February 19, 2019 Category: Medical Devices Authors: Nancy Crotti Tags: 510(k) Blog Business/Financial News Food & Drug Administration (FDA) Neurological News Well Regulatory/Compliance Robotics ReWalk Robotics Source Type: news

FDA goes after California stem cell doc for unapproved breast implant device
The FDA this week sent a warning letter to a Beverly Hills, Calif.-based surgeon for their marketing of an unapproved implantable device, dubbed the Pocket Protector, which the surgeon claims can prevent and treat capsular contracture, or scar tissue tightening, during breast implant procedures. In its letter, the federal watchdog also accuses the surgeon, Dr. Mark Berman, of “significant deviations from the FDA’s quality system requirements and current good manufacturing practices,” including charges related to the sterility of implantable devices. “This is not the first time the FDA has notified D...
Source: Mass Device - February 15, 2019 Category: Medical Devices Authors: Fink Densford Tags: Cosmetic/Aesthetic Featured Food & Drug Administration (FDA) Stem Cells Source Type: news

Corindus asks FDA for expanded neurosurgery indication for CorPath GRX
Corindus Vascular Robotics (OTC:CVRS) said today that it submitted an application seeking FDA premarket clearance to use its CorPath GRX robotic surgical platform in neurovascular interventions. The Waltham, Mass.-based company has already received FDA clearance for percutaneous coronary interventions, which it won in 2016, and for peripheral vascular interventions, which it won last year. “The ability to treat neurovascular disease with CorPath GRX is the first step for physicians to gain critical experience with robotics. Applying the benefits of robotic precision to neurovascular intervention, while building a w...
Source: Mass Device - February 14, 2019 Category: Medical Devices Authors: Fink Densford Tags: Featured Food & Drug Administration (FDA) Neurological Regulatory/Compliance Robotics Surgical Corindus Vascular Robotics Source Type: news

Long-term stroke risk cut by carotid surgery or stenting
Methods of treating carotid artery disease. (Image from Mayo Clinic.) An international research team who compared the long-term effects of carotid artery surgery and stenting found the risk of stroke “remarkably low” even 10 years later, regardless of the type of procedure. Short-term stroke prevention was found to be better among surgery patients, but stenting technology has improved since these patients were implanted, said the study’s lead author, who predicted that short-term outcomes of stenting could soon match those of surgery. Get the full story on our sister site, Medical Design & Outsourcing. The post...
Source: Mass Device - February 11, 2019 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Cardiovascular Clinical Trials Implants Neurological News Well Research & Development Mayo Clinic universitycollegelondon Source Type: news

Philips launches Epiq Elite ultrasound system
Philips (NYSE:PHG) said yesterday that it launched its new Epiq Elite ultrasound system. The newly launched system from the Amsterdam company contains its “latest advances in transducer innovation,” as well as its first solution for vascular assessment and diagnosis. “Our new portfolio of dedicated systems and solutions based on the EPIQ Elite combines new display technology, innovative transducers, advanced software and enhanced processing power. With one in four stroke cases caused by vascular disease of the carotid artery in the neck, vascular health is a growing concern worldwide. Ultrasound is the i...
Source: Mass Device - February 8, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Imaging Ultrasound Royal Philips 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

FDA expands indications for Medtronic ’ s Pipeline Flex embolization device
Medtronic (NYSE:MDT) said today it won expanded FDA approval for its Pipeline Flex embolization device. The device is now indicated for patients with small or medium, wide-necked brain aneurysms in the territory from the petrous to the terminus of the internal carotid artery, the Fridley, Minn.-based company said. The Pipeline Flex was previously cleared for the endovascular treatment of adults with large or giant wide-necked intracranial aneurysms from the petrous to the superior hypophyseal segments, Medtronic said. Clearance came based on data from the 141-patient PREMIER trial of the device, which reported a one-year ...
Source: Mass Device - February 7, 2019 Category: Medical Devices Authors: Fink Densford Tags: Featured Food & Drug Administration (FDA) Regulatory/Compliance Vascular Medtronic Source Type: news

Medtronic touts study data for thoracic aortic stent
Medtronic (NYSE:MDT) said that its thoracic stent graft for the treatment of a potentially deadly blunt-force chest injury performed well five years after implantation, according to a new study. The Rescue study of the long-term durability, safety, and efficacy of the Medtronic’s Valiant Captivia thoracic stent graft system for blunt thoracic aortic injury (BTAI) was presented at The Society of Thoracic Surgeons annual meeting in San Diego this week. It was the first five-year, industry-issued dataset ever reported for patients with aortic transections undergoing thoracic endovascular aortic repair (TEVAR). BTAI is...
Source: Mass Device - January 30, 2019 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Clinical Trials News Well Research & Development Stent Grafts Medtronic Society of Thoracic Surgeons Source Type: news

Perfuze raises $3m seed round for Millipede stroke catheter
Perfuze said today that it raised more than $3 million for the Millipede catheter it’s developing to treat ischemic stroke. Although not quite in stealth mode, the Galway, Ireland-based firm is close-mouthed about its technology. CEO Wayne Allen and CTO Liam Mullins (who co-founded Embo Medical before its  in 2015,  $YY acquisition by C.R. Bard in 2015) founded Perfuze last year. The €3 million ($3.4 million) seed round, earmarked for Millipede development, was led by European VC shop Earlybird. MedFocus, Enterprise Ireland and an Irish syndicate of medtech veterans and stroke physicians also participated, Pe...
Source: Mass Device - January 29, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Catheters Featured Funding Roundup Neurological Perfuze Stroke Source Type: news

InspireMD touts results of ‘one-size-fits-all’ stroke-prevention study
InspireMD’s CGuard embolic prevention stent A clinical trial of  InspireMD’s (NYSE:NSPR) CGuard embolic prevention stent showed that it successfully treated patients whose carotid arteries varied in size, according to the company. The investigator-initiated trial in Germany used a 10 mm diameter CGuard stent with SmartFit technology across a broad range of carotid artery diameters. Variations in diameters of the common carotid artery (CCA) and the internal carotid artery (ICA), as well as inaccurate x-ray images caused by projection angles, make choosing the correct size choice of a carotid stent challenging, a...
Source: Mass Device - January 28, 2019 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Clinical Trials Implants Neurological News Well Research & Development Stents InspireMD Source Type: news