X-ray imaging is a cornerstone of modern medicine, but it comes with substantial risk for patients and healthcare providers. CT scanners, fluoroscopes, and mammography machines have to produce a great deal of ionizing radiation because existing silicon-based detectors aren’t very efficient at capturing incoming X-rays. Most of the radiation p (Read more...)
Tag: Radiology
Abbott TriClip Cleared in Europe for Minimally Invasive Tricuspid Valve Repair
Abbott announced that it received the European CE Mark for its TriClip Transcatheter Tricuspid Valve Repair System, a minimally-invasive device for tricuspid regurgitation repair. Like many other valve repair devices, TriClip is designed for implantation using a minimally-invasive transcatheter procedure. Unlike other devices, however, TriClip work (Read more...)
Optimizer System for Cardiac Contractility Modulation: Interview with Dr. Ishu Rao, Medical Director of Impulse Dynamics
Impulse Dynamics, based in Mt. Laurel, New Jersey, has developed the Optimizer system, a device designed to improve myocardial contractility in patients with heart failure. The system is intended to improve the quality of life of heart failure patients by reducing the severity of their symptoms. At present, many heart failure patients have few opti (Read more...)
Next-Gen TherOx SuperSaturated Oxygen Delivery System FDA Approved
ZOLL Medical, now a part of Asahi Kasei Group, won FDA approval for the latest version of its TherOx System. The product is designed to deliver SuperSaturated Oxygen (SSO2) therapy to limit heart muscle loss following “widowmaker” heart attacks, aka left anterior descending ST-elevation myocardial infarction (LAD STEMI) chronic total ob (Read more...)
Gold Nanoparticles Help Uncover Fine Structure of Amyloid Fibrils
A team of scientists, based at Swiss Federal Institute of Technology Lausanne (EPFL) with collaborators at Ulm University in Germany, University of Modena and Reggio Emilia in Italy, and MIT, have developed custom nanoparticles for high-resolution detection of amyloid fibrils, those associated with Alzheimer’s and Parkinon’s. The newly (Read more...)
Micro-OCT Lets Docs Spot Tumors Below Tissue Surface
A collaboration between researchers at Nanyang Technological University, Harvard Medical School, and University of Alabama has led to the development of a prototype device capable of imaging through tissues at resolutions down to 1 micrometer (μm). The micro-OCT imager takes advantage of optical coherence tomography (OCT) at wavelengths between (Read more...)
EchoNous Receives EU Approval for Kosmos AI Ultrasound Platform
EchoNous announced that it has received the Eurepean CE Mark of approval for its Kosmos platform, an ultrasound and AI-based software system that helps physicians obtain diagnostic imaging and make clinical decisions at the bedside. The Kosmos platform consists of an eight-ounce ultrasound device, the Kosmos Torso, which also has ECG and digital au (Read more...)
Iris Needle Guidance for Lumbar Punctures: Interview with Dev Mandavia, CEO of Ethos Medical
Ethos Medical, a startup founded by Georgia Tech alumni, has developed the Iris needle guidance system to assist clinicians in successfully performing lumbar punctures. The system allows a clinician to visualize the needle traveling through tissue in real time. Tracking the needle path in this way is intended to improve the success rate and reduce (Read more...)
RefleXion X1 Cleared to Deliver Radiotherapy and Radiosurgery in U.S.
RefleXion Medical, a company based outside of Oakland, California, won FDA clearance for its RefleXion X1 machine to be used for stereotactic body radiotherapy (SBRT), stereotactic radiosurgery (SRS), and intensity modulated radiotherapy (IMRT). The X1 brings together fan-beam CT imaging and a linear accelerator inside a gantry that can spin up to (Read more...)
Stereotaxis Genesis Robotic Magnetic Navigation System Cleared in U.S.
Stereotaxis, with offices in St. Louis, MO and the Netherlands, has won FDA clearance for the Genesis RMN System, a new generation of the company’s robotic navigation systems for the delivery of magnetic ablation catheters to address cardiac arrhythmias. The system can access all chambers of the heart and coronary vasculature, and can also be (Read more...)
NeuroPace RNS System for Epilepsy Gets FDA Approval for MRI Labeling
Mountain View-based NeuroPace today announced it has received FDA approval for MRI labeling for its RNS System, a closed-loop brain-responsive neurostimulation system designed to prevent seizures in adults refractory to antiseizure medications. The approval applies specifically to the RNS-320 model of the RNS neurostimulator. Because MRI scans are (Read more...)
Abbott’s FlexNav Cleared in EU to Deliver Portico Transcatheter Aortic Valve
Abbott announced that it received the EU CE Mark for the new FlexNav delivery system for the company’s Portico transcatheter aortic valve. Transcatheter aortic valve replacement (TAVR) is a minimally invasive procedure for patients diagnosed with aortic stenosis, a condition which restricts blood flow through the valve. TAVR is particularly i (Read more...)
Cardiovalve Wins FDA Breakthrough Device Designation for Transcatheter Tricuspid Valve Replacement System
Cardiovalve announced that it received FDA Breakthrough Device Designation for its Transcatheter Tricuspid Valve Replacement System. The company also received approval for an Early Feasibility Study of the device for tricuspid and mitral valve regurgitation indications. The Cardiovalve transcatheter system is designed for treatment of mitral a (Read more...)
nView Medical’s Fast 3D Intraoperative Imaging with Less Radiation: Interview with CEO Cristian Atria
Fluoroscopy is used in surgical procedures to visualize structures and tools in real-time, allowing surgeons to monitor the movement of a device, instrument, or body part. However, fluoroscopy is a 2D technology that can lead to surgical inaccuracies. Alternative 3D imaging systems provide higher accuracy, but they sometimes require pausing the sur (Read more...)
New HydroPICC Prevents Clogged Central Line Catheters
Access Vascular, based in Bedford, Massachusetts, won FDA clearance for the latest version of its HydroPICC anti-thrombogenic central line catheter. As with the original, which was cleared two years ago, the new device features Access’s unique “bulk-hydrophilic” material that prevents clogging by being rich in water while carrying (Read more...)
VistaScan Ultrasound Probes for Your Smartphone Cleared by FDA
Emagine Solutions Technology, a startup based in Tucson, Arizona, won FDA clearance for its VistaScan mobile ultrasound system. The product includes ultrasound probes that can interface with a clinician’s own smartphone or tablet, and the company’s app is used to display and manipulate live images produced by the probes. The company dev (Read more...)
Adjustable Heart Valves Grow with Kids Hearts
A variety of congenital cardiac abnormalities require the placement of prosthetic heart valves in very young children. As the hearts grow, the valves have to be replaced through repeated surgeries. A team of researchers from Harvard and Boston Children’s Hospital have now developed an artificial valve that can be expanded, via a minimally inv (Read more...)
Stretchy Coils to Make MRI Imaging Easier on Patients
When undergoing MRI scanning, many patients have to have the body parts being imaged strapped into rigid radio-frequency (RF) coils. These can be uncomfortable, as they’re not custom-sized for every patient, and since many MRI exams can take a half hour or more to perform, the scanning process can be difficult for many to undergo. […]
Contour Treats Brain Aneurysms Using Single Device
Cerus Endovascular, a firm based in Fremont, California, won the EU’s CE Mark for the Contour Neurovascular System, the company’s flagship product. Designed to treat intracranial aneurysms, the Contour is a mesh braid that diverts and disrupts blood flow in and out of an aneurysm. The device is positioned at the neck of the aneurysm [&h (Read more...)
Stain and Label-Free Microscopy Enables Imaging of Extracellular Vesicles
Researchers at the Beckman Institute of the University of Illinois at Urbana–Champaign have developed a method that employs ultrashort laser pulses to visualize extracellular vesicles in tissue samples without using stains or labeling compounds. An increase in the number of these small vesicles is known to be associated with cancer, whereby c (Read more...)