Last month, Medtronic announced receipt of U.S. Food and Drug Administration (FDA) approval for and launch of the Evolut Pro+ TAVR (Transcatheter Aortic Valve Replacement) System to treat patients with symptomatic severe aortic stenosis. Aortic stenosis is characterized by stiff, often thickened aortic valve leaflets that struggle to open and close (Read more...)
Author: Medgadged
FDA Clears geko Muscle Pump Activator to Prevent VTE
Venous thromboembolism (VTE) too often strikes bedridden patients in the hospital, and this is one of the main reasons that patients are put back on their feet as soon as possible. Inflatable wraps placed around the legs, which can raise the pressure, are a common way to prevent the condition. Now, a device called geko […]
3D Liquid-Cell Electron Microscopy Imaging Now Possible
Electron microscopy revealed a world that exists at scales smaller than the wavelength of light. Advancements in this field have allowed scientists to visualize ever more objects and processes, but actually seeing living cells in 3D and within a liquid environment has been impossible. Now, a team of researchers from Penn State University, Virginia (Read more...)
Peptide Particles Ferry Drugs Across Blood-Brain Barrier
Most drugs, genetic materials, and other therapeutic agents are very difficult to use inside the brain because of the blood-brain barrier. There have been attempts to use ultrasound and microbubbles to create temporary passages through the barrier, including as a possible therapy for Alzheimer’s disease, but this is approach is not easy or id (Read more...)
Noble’s Self-Injection Trainers for Rheumatoid Arthritis Drugs: Interview with Joe Reynolds, Research Manager
Last year, Medgadget heard from Noble International about its “smart” training devices that educate patients on safe and effective at-home use of prefilled syringes and autoinjectors. At the time, Joe Reynolds, Research Manager at Noble International, shared some use cases for the company’s products, including rheumatoid arthritis (Read more...)
Microfluidic Device for Rapid Lyme Disease Diagnosis
Researchers at Columbia University have developed a microfluidic device that can diagnose Lyme disease in as little as 15 minutes. The device is particularly accurate in identifying antibody biomarkers that are present during early stage Lyme disease, raising hopes that it could be useful in detecting cases of early infection in a doctor’s of (Read more...)
iRhythm-Verily Partnership: Interview with iRhythm CEO Kevin King
iRhythm and Verily announced a partnership last month to “co-develop solutions intended to provide early warning, diagnosis and management for patients, particularly for those with silent or undiagnosed AF.” We spoke with iRhythm CEO Kevin King to understand how the two companies complement each other and how they can solve the problem (Read more...)
Light Therapy Device to Treat Carbon Monoxide Poisoning
Carbon monoxide (CO) is one of the most common substances that people are poisoned by. It has no smell and is invisible to the naked eye, but can cause severe damage to tissues and lead to death. Patients who have already suffered significant lung damage because of CO inhalation too often don’t respond sufficiently to […]
Sweat Sensors Help Predict Outbursts in Autistic Kids
Kids with autism can become unruly and aggressive, often without any warnings for those around them. Such outbursts can also be emotionally difficult for family and caretakers, not just the kids, and planning events and going into public places is a major challenge. Having a bit of warning about an autistic child’s worsening mental state [&he (Read more...)
Medtronic’s Tiny New InterStim Micro Neurostimulator Submitted to FDA
Medtronic has filed for FDA approval for its InterStim Micro neurostimulator and the accompanying InterStim SureScan MRI leads. The rechargeable device delivers sacral neuromodulation therapy to treat conditions such as overactive bladder, fecal incontinence, unobstructed urinary retention, and urinary urge incontinence. Along with the InterStim Mi (Read more...)
Low Power MRI Helps Image Lungs, Brings Costs Down
Modern clinical MRIs usually have magnetic field strengths of 1.5 or 3.0 Tesla. These are pretty powerful magnets and it’s the reason that these devices are very expensive. While such strengths have been standard for a long time, the internal hardware and software beyond the magnets have been improving steadily. Now, researchers affiliated wi (Read more...)
Dexcom G6 Pro with Blinded Mode FDA Cleared
Dexcom landed FDA clearance for its Dexcom G6 Pro continuous glucometry system. Intended to be used by medical professionals with their patients, it offers a novel “blinded” mode that allows physicians to hide live glucose readings from patients. Using this capability, doctors can review glucometry data and propose lifestyle changes to (Read more...)
New Drug Capsule for Oral Delivery of Insulin, Protein-Based Drugs
Most drugs are administered in pill form, but some have to be injected because they would otherwise be broken down by the gastrointestinal tract. This limitation mostly applies to protein-based drugs. Insulin, essentially a small protein (aka peptide), is by far the most injected medication in the world. It saves lives, but injections can be [&hell (Read more...)
Deep Learning Spots Organs on CT Scans to Prevent Radiation Damage
Radiotherapy is a well established method for attacking tumors within the body. There are a number of techniques that are used to administer radiation to a lesion, but they all come with the risk of injuring nearby tissues and organs. Gamma beams and other directed high energy devices result in the exposure of all the […]
3D Microenvironments to Grow Brain Tumors in Lab
Clinical researchers are constantly thwarted by the inability to quickly and easily try new therapies in tumors and other disease targets. Tumors within the brain are particularly hard to study because of the difficulty with access and the incredible fragility of nearby tissues. Researchers at Tufts University have just developed a way to create an (Read more...)
Gore CARDIOFORM ASD Cleared in Europe for Atrial Septal Defects
Gore won the European CE Mark for its GORE CARDIOFORM ASD Occluder, a device designed for percutaneous, transcatheter closure of ostium secundum atrial defects (ASDs). The occluder recently completed a clinical study involving 125 patients with ASD, ranging from 2 to 84 years of age, all of whom were successfully implanted with the GORE CARDIOFORM (Read more...)
Epica SeeFactorCT3 Multi-Modality System Wins FDA Clearance
Epica, a company based in San Clemente, California, won FDA clearance for its SeeFactorCT3 system that combines computed tomography (CT), fluoroscopy, and digitial radiography (DR) into a single device. It is intended for use in diagnostic, interventional, and intraoperative procedures mostly involving the head, neck, and extremities. As such, it i (Read more...)
Electrified Graphene Filters Kill All Pathogens and Their Byproducts
Pathogenic bacteria are usually the culprits responsible for the spread of nosocomial infections, but there are other sources of disease in hospitals, including viruses, fungi, their spores, prions, and endotoxins produced by bacteria. Existing methods and standards usually involve two filter beds being used within hospitals’ ventilation syst (Read more...)
Soft Robotic Glove for Hand Grasp Rehab
All sorts of conditions, including muscular dystrophy, ALS, and partial spinal cord injury, result in patients losing their ability to confidently grasp objects with their hands. Regaining this important capability is usually a priority, as it is one of the biggest impediments to living a normal life. Now, researchers at Harvard’s Wyss Instit (Read more...)
Nobel Prize in Physiology or Medicine 2019 Announced for Cell Oxygen Regulation
Two Americans and an English knight have won this year’s Nobel Prize in Physiology or Medicine for their discovery of how cells detect how much oxygen is available to them and the mechanism that regulates how they adapt to changes in oxygen levels. While the scientific community recognized the importance of oxygen for animal cells […]