For years, catheter-based minimally invasive procedures have depended on X-ray imaging to guide physicians toward the treatment site. New tools, including intravascular ultrasound (IVUS) and fractional flow reserve (FFR), which measures blood pressure inside a vessel, are giving physicians additional perspectives. Using these modalities in a single procedure therefore requires coherently combining all the information […]
Author: Medgadged
Neuroform Atlas Stent System FDA Approved to Treat Brain Aneurysms with Embolic Coils
The FDA has issued Stryker with approval for the company’s Neuroform Atlas Stent System. It is indicated for treatment of wide-neck, intracranial aneurysms in conjunction with embolic detachable coils, so far only the second stent approved for such procedures. The nitinol Neuroform Atlas stent is used to hold tiny metal coils inside an aneurysm, working […]
LifeFlow Next Gen for Sepsis and Shock Makes Infusions Easier and Safer
410 Medical, a Durham, North Carolina firm, is releasing a new version of its LifeFlow rapid infuser for treating patients during sepsis or shock. The LifeFlow Next Gen can safely deliver 500 ml of crystalloid fluid in less than two minutes, nearly four times faster than when using a pressure bag. Device is operated with […]
StimGuide Navigation System for Horizon Transcranial Magnetic Stimulator
Magstim, a company Wales, UK firm that just won FDA clearance for a 3 minute magnetic stimulation protocol for major depression, is releasing a new navigation system for the Horizon transcranial magnetic stimulation (TMS) platform. The StimGuide was developed specifically for use by clinicians, as opposed to researchers, to help deliver consistent results when treating […]
Brain Controlled-Hearing Aid Separates Voices in a Crowd
When we are at a party and talking to someone, our brain is able to identify a single speaker’s voice and focus our hearing on it, helping us to listen more closely and ignore the other voices nearby. For the millions of people with hearing impairment who use hearing aids, they often lose this ability, […]
Masimo Radius PPG Wireless Oximeter FDA Cleared
Masimo won FDA clearance for its Radius PPG wireless pulse oximetry sensor. The device features Masimo’s SET Measure-through Motion and Low Perfusion technology that stays accurate as the patient moves around and about. The tetherless product allows patients to freely move about the clinic, going to the bathroom without having to disconnect from the monitor, […]
Impella CP with SmartAssist: A Newly FDA Approved Heart Pump with Optical Positioning Sensor
Abiomed, the maker of popular left ventricular assist devices, is releasing its newly FDA approved Impella CP with SmartAssist device. The pump features an optical sensor that physicians can use to position and reposition the device without relying on a cath lab, X-ray, or ultrasound imaging. The sensor can be used either during initial implantation […]
Magstim FDA Cleared for 3 Minute Magnetic Stimulation Protocol for Major Depression
The FDA has cleared Magstim, a company based in Wales, to introduce its intermittent Theta Burst Stimulation (iTBS) as a treatment for Major Depressive Disorder. The therapy is available on the company’s Horizon transcranial magnetic stimulation (TMS) systems and only takes about three minutes per session. Previously, so-called repetitive transcranial magnetic stimulation (rTMS) using the […]
RhythmAnalytics Detects Cardiac Arrhythmias Using AI, Now FDA Cleared
Biofourmis, a company with offices in Singapore and Boston, won FDA clearance for its RhythmAnalytics cloud-based software that uses artificial intelligence techniques to automate the interpretation of cardiac arrhythmias from ECG tracings. The system can detect more than fifteen different types of arrhytmias including using beat-by-beat morphology analysis to spot ventricular arrhythmias, ventricular ectopic beats, […]
FDA Clears Software to Spot Collapsed Lung in Chest X-rays
Zebra Medical Vision, an Israeli firm, landed FDA clearance for the HealthPNX automated chest X-ray analysis software that can independently spot signs of pneumothorax (PNX), colloquially known as collapsed lung. The software can help radiologists quickly and confidently identify the cause of a patient’s symptoms, allowing for emergency treatment to begin ASAP. Due to a […]
Microscopic Graphene Flakes to Stop Epileptic Seizures
During epileptic seizures, the brain’s excitatory neurons go haywire, generating extreme amounts of electric activity. There are already electronic devices available that help to prevent and mitigate seizures, but so far they’re only effective in some patients while having all the downsides of a serious implantation. A team of European researchers from Sissa (International School […]
Magnetic Beads Strip Blood Samples to Allow Circulating Tumor Cell Isolation
Researchers at the University of Georgia have developed a microfluidic chip to isolate circulating tumor cells (CTCs) from blood samples. Unlike other devices, this new chip uses magnetic microbeads to strip all the cells from the blood, leaving only the CTCs, in a technique the researchers have called “integrated ferrohydrodynamic cell separation”. The device is […]
Smartphone App Uses Phone Microphone to Hear Ear Infections
Researchers at the University of Washington have developed a smartphone app that can detect ear infections. By holding the phone and a small paper cone close to the ear of a patient, a clinician can use the app to diagnose an infection. The app emits a sound through the phone’s speaker, and the microphone picks […]
Synthetic Proteins Designed to Halt Growth of Cancers
Stanford University scientists have developed a novel approach to halting the growth of cancer cells while preserving normal function in healthy cells. The research was published in journal Science, and though it was so far conducted only on groups of cancer cells outside a body, the findings are incredibly promising. The new approach focuses on […]
Artificial Intelligence to Speed up Alzheimer’s Disease Research
Researchers from UC Davis and UC San Francisco have developed a new artificial intelligence tool to scale up Alzheimer’s research. They have created a deep learning system to identify amyloid plaques in brain slices of patients, spotting specific subtypes of Alzheimer’s disease, in the process enabling precision medicine and faster research. The team used a […]
Medtronic Unveils Telescope Guide Extension Catheter for Delivery of Coronary Tools
Medtronic announced that it’s releasing its new Telescope Guide Extension Catheter, a device that helps to support coronary interventional instruments and extends access to difficult to reach lesions. The Telescope GEC already has regulatory clearances in the United States and European Union. The device features a solid, round pushwire with a coil-reinforced hydrophilic-coated distal segment. […]
Haemonetics TEG 6s Hemostasis Analyzer Cleared for Trauma Testing
Haemonetics won FDA clearance for its TEG 6s Hemostasis Analyzer System to be used in adult trauma settings to evaluate the viscoelasticity of patients’ blood. The system relies on an all-in-one cartridge into which a small sample of blood is placed. The cartridge already has the necessary reagents within itself, automatically mixing them with the […]
System Separates, Sequences Circulating Tumor Cells from Whole Blood
Engineers at the University of Michigan have developed a high speed microfluidic chip that can separate circulating tumor cells (CTCs) from whole blood and analyze them. The technology, which may make biopsies and other diagnostic tests unnecessary in many cases, is impressive in that it is able to attract highly rare CTCs and to sequence […]
Prevena Negative Pressure System FDA Approved for Superficial Surgical Site Infections
KCI, now a part of the Acelity Company, has announced that its PREVENA negative pressure incision management system is the first to receive FDA’s indication to help with reducing superficial surgical site infections in those at high risk of post-op infections. The approval comes under the FDA’s de novo pathway that was designed to bring […]
Prevena Negative Pressure System FDA Approved for Superficial Surgical Site Infections
KCI, now a part of the Acelity Company, has announced that its PREVENA negative pressure incision management system is the first to receive FDA’s indication to help with reducing superficial surgical site infections in those at high risk of post-op infections. The approval comes under the FDA’s de novo pathway that was designed to bring […]