Compumedics, a company based outside of Melbourne, Australia, has won FDA approval for its Orion LifeSpan Magnetoencephalography (MEG) single Dewar system. MEG is a promising imaging technique that uses superconducting quantum interference devices (SQUIDs) to detect ionic currents produced by excited neurons, giving a window into the live activity (Read more...)
Tag: Radiology
Scientists Make Organs Transparent
Whole organs are difficult to study in minute detail, as they have to be sliced into extremely thin sections to map out their interior. CT and magnetic resonance imaging help to an extent, but researchers at the Helmholtz Zentrum München, Ludwig Maximilians University Munich, and Technical University of Munich in Germany have managed to make [ (Read more...)
QyScore Analyzes MRIs for Biomarkers of Brain Diseases
Qynapse, a firm headquartered in Paris, France, won FDA clearance for its QyScore software that analyzes brain MRIs for biomarkers of central nervous system diseases. It’s intended to help diagnose and monitor diseases such as Alzheimer’s, Parkinson’s, and multiple sclerosis, though it doesn’t do it on its own. The technolog (Read more...)
World’s First Portable MRI Cleared by FDA
Magnetic resonance imaging (MRI) has revolutionized medicine, but MRI scanners are so demanding that access to them is still a challenge. MRI machines typically require specially built rooms with magnet quench vent pipes, entry systems that check people for metals attracted to magnets, and specific protocols to ensure safety. Patients, therefore, h (Read more...)
Ethos AI-Powered Radiotherapy System Follows Movement of Tumors
Varian has won FDA clearance for its Ethos therapy technology, which the company describes as an Adaptive Intelligence solution for improved tumor targeting during radiotherapy. Adaptive therapy allows clinicians to target tumors based on imaging performed during treatment sessions. This is important, as the internal anatomy tends to shift and tumo (Read more...)
First AI-Guided Ultrasound Gets Green Light from FDA
Caption Health, a company based outside of San Francisco, CA, won the first authorization from the FDA for an ultrasound software that guides clinicians at capturing images of the heart. The Caption Guidance software should work with any number of ultrasound system from different manufacturers, but currently it can only be used with a diagnostic [& (Read more...)
Abbott’s Tendyne First Transcatheter Mitral Valve to Win EU Clearance
Abbott just announced that it is the first company to receive European regulatory approval to introduce transcatheter mitral valve replacement procedures on the continent. The Tendyne Transcatheter Mitral Valve Implantation (TMVI) system is intended for mitral regurgitation patients for whom open-heart surgery is too risky and in cases where transc (Read more...)
Imricor’s MRI-Compatible Ablation Catheters Cleared in Europe for Cardiac Arrhythmia Treatment
Imricor Medical Systems, based outside of Minneapolis, Minnesota, has won the European CE Mark for its Vision-MR Ablation Catheter and Vision-MR Dispersive Electrode. These devices allow for cardiac ablation procedures to be performed within MRI-equipped operating rooms, thereby utilizing the accuracy of intraoperative MRI to target sources of arrh (Read more...)
Sony Releases NUCLeUS OR Platform in U.S.
Sony is releasing its NUCLeUS system in the United States. The system helps clinicians working in and around operating rooms to access and share imaging data. NUCLeUS already provides support at over 500 ORs in Europe, so it has already proven itself in clinical practice. The system supports images and video up to 4K resolution, […]
GammaTiles Help Prevent Recurrence of Malignant Brain Tumors After Surgery
GT Medical Technologies, a company based in Tempe, Arizona, won FDA clearance for its GammaTiles to be used to prevent malignant brain tumors in newly diagnosed patients. The devices, about the size of a postage stamp, contain Cesium-131, a radioactive isotope with a half life of about ten days. The collagen material within which the […]
Mindray’s New High End Point of Care Ultrasound
Mindray is releasing a new point-of-care ultrasound system, the TE7 ACE. The device, intended for a variety of applications including emergency, critical care, and anesthesia, features a large color touchscreen, fluid management features, needle guidance toolkit, and electronic medical records connectivity. The company claims that the fluid measure (Read more...)
Magnetized Particles Show Live Metabolic Activity of Breast Cancer
Current imaging methods that are used to spot tumors don’t provide much information about the rate of activity of the cells making up the diseased tissues. Breast cancer tumors, for example, are mostly classified into a few categories based on hormone receptor and HER2 expression. Researchers at Cancer Research UK Cambridge Institute and the (Read more...)
Argon Releases Universal IVC Filter Removal Kits
Argon Medical Devices, a company based out of Frisco, Texas, is launching two kits for retrieving inferior vena cava (IVC) filters. IVC filters are used to prevent pulmonary embolisms, but when a patient no longer needs one it has to be removed. The two Argon kits are designed to fish out any retrievable IVC filter […]
TriNav System Uses Pressure to Push Drugs into Solid Tumors
TriSalus, a Denver, Colorado firm, is launching a new solid tumor infusion system to target hepatocellular carcinoma, liver metastases, and other tumors. The TriNav Infusion System features the company’s SmartValve and Pressure-Enabled Drug Delivery (PEDD) technologies to get more of the tumor killing drug inside the diseased tissue. The trea (Read more...)
InterStim Micro Neurostimulator and SureScan MRI Leads Cleared in Europe for Incontinence Control
Medtronic won EU regulatory clearance to introduce its InterStim Micro neurostimulator and InterStim SureScan MRI leads. The devices are used to deliver sacral neuromodulation therapy to treat overactive bladder (OAB), fecal incontinence, and non-obstructive urinary retention. The InterStim Micro is a much tinier version of Medtronic’s InterS (Read more...)
Augmedics Secures FDA Clearance for xvision, an AR Surgical Guidance System
Augmedics, a Chicago-based startup developing surgical virtual reality technologies, received FDA 510k clearance for its augmented reality (AR) xvision system. xvision is comprised of a headset that emulates “X-ray vision” during surgery by projecting 3D navigation data onto the surgeon’s retina. Designed using transparent hardwar (Read more...)
Laser Ultrasound System Images People’s Insides from a Distance
Clinical non-invasive ultrasounds require their transducers to make contact with the skin, as that allows high frequency vibrations to travel through the body. Many patients, including children, people with burns, and those with sensitive skin would rather be scanned using a contact-free system. Researchers at MIT have now shown that it is indeed p (Read more...)
FDA Clears Two New Radiotherapy Planning CTs from Siemens
Procedure planning is an important part of radiation therapy in order to achieve optimal tumor reduction without damaging too much healthy tissue. Two newly FDA-cleared radiation therapy planning CT scanners from Siemens Healthineers are coming to America. The SOMATOM go.Sim and SOMATOM go.Open Pro are part of the company’s SOMATOM.go platfor (Read more...)
Watching for Radiation Harm After Interventional Procedures
Staff and patients exposed to radiation during interventional procedures can experience lens opacities that differ from cataracts typically seen in clinical practice and with other skin injuries. Medscape Medical News
Macadamian, Radiobotics, and Bispebjerg Hospital Partner on AI Solution for Radiology: Interview
While the number of clinical data points available per patient continues to increase exponentially, the number of providers and specialists available to interpret that data fails to keep pace. As a result, technology-driven automation is becoming more important to quickly assess and triage patients as new information becomes available. One clinical (Read more...)