Medtronic won FDA regulatory approval and is releasing in the U.S. its Resolute Onyx drug-eluting (zotarolimus) stent. The device is based on the company’s Resolute Integrity device and is available in 4.5 mm and 5.0 mm diameters for patients with larger coronary arteries. It is designed for transradial delivery via a 5 French catheter. The […]
Tag: Radiology
BIOTRONIK Releases New Line of MR-Conditional Pacemakers, CRT-Ps
BIOTRONIK is releasing a new line of MR-conditional pacemakers, the smallest the company has produced, and new quadripolar cardiac resynchronization therapy pacemakers (CRT-P). The Edora devices allow patients to receive MRI exams, as long as certain precautions are taken, and feature MRI AutoDetect feature that automatically puts an implant into safe mode when it’s near an MRI […]
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Breast Cancer Detection Using Ultrasound: Interview with Dr. Georgia Giakoumis Spear, NorthShore University Health System
Detecting breast cancer is of vital importance in terms of treating it early and effectively. Mammography is the gold standard in routinely screening women for breast cancer. However, in a subset of women with dense breast tissue, mammography doesn’t work as well as one would hope. In fact, it can miss up to a third […]
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GORE VIATORR TIPS Endoprosthesis for Transjugular Intrahepatic Portosystemic Shunt Procedures Gets FDA Approval
W. L. Gore & Associates, better known simply as Gore, received FDA approval and is making available in the U.S. its for its GORE VIATORR TIPS Endoprosthesis with Controlled Expansion. It’s intended for Transjugular Intrahepatic Portosystemic Shunt (TIPS) procedures that link the portal vein to the hepatic vein to reduce the portal hypertension in patients with end-stage […]
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ARTIS pheno, Siemens’ New Flagship Angiography C-arm Cleared by FDA
Siemens won FDA clearance for its new ARTIS pheno robotic angiography C-arm. The system is essentially an upgraded version of the company’s Artis zeego (even the capitalization of the name has changed), sporting a zen40HDR flat panel detector and GIGALIX X-ray tube. The system features automatic dose selection to minimize radiation exposure and generates 3D scans that need […]
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Robots Powered by Clinical MRI Machine to Work Inside Body
At the University of Houston researchers are working to develop diagnostic and therapeutic devices that can be steered and powered using the magnetic field of an MRI scanner. So far the researchers have been able to get blocks about two centimeters on a side to move in predetermined ways inside a specially-built box. They hope […]
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New Chemo Drug Eluting Beads for Liver Tumors Cleared in Europe
BTG, a company based in London, UK, won European CE Mark clearance for its DC Bead LUMI radiopaque drug-eluting bead. This is the first such device available in Europe. The beads can be loaded with either doxorubicin or irinotecan, commonly used chemo agents, and injected into tumors within the liver. Their radiopaque quality, thanks to a compound […]
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Tryton Side Branch Stent For Treatment of Coronary Bifurcated Lesions FDA Approved
Tryton Medical out of Durham, North Carolina won FDA approval for its Tryton Side Branch Stent. The innovative device is designed to be placed into a side branch artery while allowing a traditional drug eluting stent to be placed into the branch’s main artery, thereby treating the entire lesion at the bifurcation. The Tryton Side Branch […]
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Serranator Alto PTA Serration Balloon Catheter Cleared by FDA
Cagent Vascular, a company based in Wayne, Pennsylvania, won FDA clearance for its Serranator Alto PTA Serration Balloon Catheter. Unlike other balloon catheters designed to dilate blood vessels, the Serranator Alto PTA has a series of teeth-like ridges on four sides of the balloon. As the balloon is pumped to push open a constricted vessel, […]
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Launch of Azurion: Philips’ Next Generation Image-guided Platform
The Azurion system builds on Philips’ many decades of imaging expertise combined with a growing integrated therapy portfolio, enhanced by the 2015 acquisition of Volcano. It is is expected to form the core of Philips’ integrated image-guided systems including vascular surgery, cardiology, oncology, and neuroradiology. The new imaging platform is underpinned by Philips’ redesigned operating system, […]
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New Bioresorbable Vascular Scaffold from Meril, an Indian Multinational
Meril, a large Indian medical device firm, has developed a drug-eluting bioresorbable vascular scaffold, which looks like a stent but that eventually and slowly degrades is washed away by the body. The MeRes100 is made of PLLA coated with PDLLA, both biodegradable polymers, while Sirolimus (rapamycin), the immunosuppressant common in drug eluting stents, is embedded within the […]
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Individual Control of Magnetic Micromachines Within The Body
Magnetic micromachines can be delivered into the body and then controlled externally using a magnetic field. Such micromachines could be used to deliver a therapeutic agent to a specific location in a minimally invasive manner or control adaptive implants. However, in many cases multiple micromachines may be required. For example, a ‘swarm’ of micromachines could […]
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Clarius Wireless, Handheld Ultrasounds Cleared in Europe
Clarius, a company based in British Columbia, Canada, received European CE Mark approval for its wireless C3 and L7 ultrasound scanners. These devices are highly portable, battery powered, and use an Android or iOS smartphone or tablet for displaying the scans. They’re even water resistant, so can be used in a wide variety of in-clinic and […]
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Simulating Blood Flow from Tomo Scans to Prep for Complex Surgeries
Modern CT and MRI scanners can provide a moving image of the heart, but they don’t show the complicated patterns of blood flow in and around the organ. Seeing the dynamic nature of patients’ hemodynamics may help surgeons prepare for complicated operations. At Stanford researchers are developing a pre-surgical tool that can take tomographic scans and simulate […]
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Medtronic Unveils New Products for Diagnostic Cath Procedures and Percutaneous Coronary Interventions
Medtronic is releasing a few new coronary devices, including the new DxTerity diagnostic angiography catheters, DxTerity TRA diagnostic catheters, InTRAkit access kit, and the TRAcelet compression device. All the products already have received U.S. and European regulatory approvals. While both of the DxTerity catheter lines are used to evaluate the need for revascularization procedures, the DxTerity […]
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Intravascular Camera Using Multiple Lasers for Illumination Helps Assess Dangerous Plagues
A collaboration between scientists at University of Washington and University of Michigan has led to the development of a new way of imaging atherosclerosis within blood vessels. The technology relies on delivering a tiny camera into a vessel’s lumen and illuminating the plagues using red, green, and blue lasers. The scanning fiber endoscope (SFE) was […]
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MRI Contrast Agent That Turns On at Sites of Disease
At the Institute for Basic Science (IBS) in South Korea, researchers have developed a new type of MRI contrast agent that only lights up when near a target. It consists of two components, an “enhancer” which is the actual contrast agent that lights up and a “quencher” that controls the activation of the enhancer. The enhancer […]
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Fidmi Medical’s Feeding Tube System Requires Fewer Changes, Easier on Patients
Fidmi Medical, a company based in Misgav, Israel, has developed a new enteral feeding device that overcomes some of the limitations, downsides, and hassles of existing solutions. Feeding tubes have to be changed every few months to prevent clogging, address dislogdgements, and get ahead of the device breaking up. The PEG (percutaneous endoscopic gastrostomy) device […]
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ABBOTT’s Assurity MRI Pacemaker and Tendril MRI Lead Now Labeled by FDA for Use During MR Scans
ABBOTT, having recently purchased St. Jude Medical, is already reaping rewards. The FDA has issued MR-conditional labeling for the Assurity MRI pacemaker and the matching Tendril MRI lead. This makes the Assurity MRI concurrently the smallest pacemaker (6mm thick) and one with the longest lifetime (10 years) of any wireless pacemaker that can be safely worn (under certain […]
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BIOTRONIK’s New Personalizable and Energy Efficient CRTs
BIOTRONIK is releasing a new line of cardiac resynchronization therapy (CRT) implants, the Ilivia series, that are designed to improve patient response to the therapy and make it customizable for individual needs. The devices are compatible under MRI and feature the company’s MRI AutoDetect capability that automatically switches the devices to a special safe mode […]
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