ResMed is releasing a new full face CPAP mask that the company claims to be its first “minimal-contact” device of this kind. The AirFit F30 mask features a cushion that avoids sitting on top of the nose, preventing rubbing of that area and disturbing the visual field of view, something that can lead to claustrophobia […]
Tag: Cardiology
Apple Unveils New Watch with ECG Built-In
Apple just unveiled its latest smartwatch, the Apple Watch Series 4, and it has one impressive new medical feature: a built-in single-lead ECG (electrocardiograph). The FDA has cleared it as a medical device, according to Apple, and we assume the clearance is for detecting certain cardiac arrhythmias, particularly atrial fibrillation. Previously, the KardiaBand from AliveCor […]
Boston Sci’s ACURATE neo2 Aortic Valve Showing High Performance
Boston Scientific is touting results of a clinical study evaluating its ACURATE neo2 prosthetic aortic valve system. The implant and delivery system, which are not yet available for sale, had “a high procedural success rate and a low rate of paravalvular aortic regurgitation,” which is blood leaking around the valve, a month after implantation, according to […]
Nuubo for Comfortable All Day ECG Arrhythmia Monitoring
Nuubo, a company based in Madrid, Spain, won FDA clearance for its Nuubo System to be used within the hospital for diagnosing arrhythmias. Unlike multi-day, multi-lead ECG monitoring often found within clinics today, the Nuubo doesn’t rely on a bunch of loose wires running under the clothing to a box on the belt. The Nuubo […]
Stanford Researchers Print Patient Specific Heart Mapping Sensors
Interventional cardiologists dealing with atrial fibrillation, the most common arrhythmia, tend to seek out and ablate the tissue generating aberrant electrical signals. This is done with mapping catheters, the shape of which is designed to maximize contact with the heart to best gather the heart’s intrinsic electrical signals. Each patient is different, so researchers at […]
GORE Molding & Occlusion Balloon Approved in US, EU, Japan
Gore is releasing its GORE Molding & Occlusion Balloon following regulatory approvals in the U.S., Japan, and Europe. The device is a compliant polyurethane balloon catheter designed for use in opening up self-expanding stent grafts or to temporarily occlude wide vessels. The company believes that the device “meets all endovascular aortic repair (EVAR) procedural requirements – a […]
OMRON Unveils Blood Pressure Monitor for Obese People
OMRON is unveiling a new automatic wrist blood pressure monitor specifically designed and validated for obese patients. The OMRON RS7 Intelli IT is planned to go on sale in Europe for €99 later this year. In order to guarantee accuracy of BP measurements, the new device has a special LED position sensor that helps to make sure […]
Two New Advanced Cardiovascular Ultrasounds Debuted by Philips
Philips is releasing two new cardiovascular ultrasound systems that feature similar capabilities, but one is designed for the office while the other is geared for the cath lab. The company says that the new systems have improved image quality and a variety of features that improve usability. The EPIQ CVx, intended for the office, lets […]
BioSig PURE EP High Resolution Electrophysiology System Cleared in United States
BioSig Technologies, out of Los Angeles, California, won FDA clearance for its novel PURE EP, a system for gathering, analyzing, and manipulating electrocardiographic and intracardiac data during electrophysiology procedures. The company believes that its system can provide a more detailed and nuanced view of the heart during ablation procedures when treating atrial fibrillation and other […]
Shift Labs Announces Partnership with Option Care Enterprises for National Use of DripAssist
DripAssist by Shift Labs is an infusion rate monitor that offers a significant improvement in portability, efficiency, durability and ease of use over traditional infusion monitors. The last time Medgadget reported on Shift Labs, the company had just received their CE mark for DripAssist. The device is also FDA approved. Now, Shift Labs is announcing a […]
First Patient Receives Medtronic’s Extravascular Implantable Cardioverter Defibrillator
A pilot study is getting underway to evaluate a new Medtronic implantable cardioverter defibrillator that doesn’t require leads to be placed inside the heart or veins. The Extravascular Implantable Cardioverter Defibrillator (EV ICD) system can deliver defibrillation shocks as well as pacing signals to the heart, but it uses only a single lead placed under the […]
Caretaker Beat-by-Beat Continuous Blood Pressure and Vital Signs Monitor Cleared in EU
Caretaker Medical, a firm based in Charlottesville, Virginia, won approval to introduce its Caretaker 4 wireless continuous non-invasive blood pressure (CNIBP) and vital signs monitoring system in the European Union. The product, already approved in the U.S., provides beat-by-beat blood pressure measurements with an accuracy sufficient for intensive care units. It also keeps track of the heart […]
Flow Diverter with Hemodynamic Sensor to Monitor Aneurysm Treatment
Flow diverters are implants that are commonly used to prevent blood from flowing into aneurysms. They look very similar to stents, and are often combined into one device, but instead of providing structural strength, they provide a way for blood to pass from one part of a vessel to another without flowing into a bulging […]
Clot Busting Nanogel: A Faster, Safer Therapy for Heart Attacks
Scientists at North Carolina State University and the University of North Carolina at Chapel Hill have developed a new way of delivering a clot buster and a mitigating drug to limit damage due to reperfusion. Currently, serious blockages leading to the myocardium are typically broken up in the cath lab, usually with a stent left […]
Implantable System for Remodulin FDA Approved to Treat Pulmonary Hypertension
Medtronic won FDA approval for its Implantable System for Remodulin (ISR) as a new treatment option for people with pulmonary arterial hypertension. It consists of Medtronic’s Synchromed II drug delivery system, an intravascular catheter, and United Therapeutics‘ Remodulin (treprostinil) Injection medication. Unlike external infusion pumps, the Implantable System for Remodulin is completely implantable, reducing infection risk and […]
“Ticker” by Mimi Swartz: A Medgadget Book Review and Interview with the Author
Of all the organs in the human body, the heart is arguably the most important, well-known, and worried about. Not only is the heart the vital electro-mechanical pump that moves about 2,000 gallons of our blood every day, but for centuries it’s been symbolic of the seat of emotion, reason, and life itself for many […]
Wearables + Telephone Coaching Didn’t Improve Peripheral Arterial Disease Symptoms
Wearables have the potential to improve our health. They can be reminders that we’re not moving enough throughout the day, and they can be useful tools for doctors to monitor the fitness progress of their patients. However, in the Journal of the American Medical Association, McDermott and her colleagues recently reported that their trial of […]
Artificial Model of Heart Ventricle for Studying Cardiac Diseases, Drugs, Therapies
Custom-built artificial hearts are still something from science fiction, but the engineering knowledge to get there is already being assembled in labs around the world. One important piece of the puzzle has just been reported on by researchers at Harvard University, who have built a model of the heart’s left ventricle, seeded with living heart […]
MACH 30 Ultrasound with ShearWave PLUS Elastography Cleared in U.S., Europe
SuperSonic Imagine, a French firm, has announced that its Aixplorer MACH 30 ultrasound has been cleared in the U.S. and Europe. The system works as a traditional high power ultrasound, but also features the company’s elastography technology called ShearWave PLUS that measures tissue elasticity, or stiffness, in 3D. Elastography is now commonly used for identifying mammary […]
PocketECG Cardiac Rehabilitation System Helps to Get Most Out of Rehab Training
Medi-Lynx Cardiac Monitoring, part of MEDICALgorithmics, a Polish firm, won FDA clearance for its PocketECG Cardiac Rehabilitation System (CRS). The device, designed to record electrocardiography signals and to automatically spot cardiac arrhythmias, is intended to be used by patients, both high and low risk, that are undergoing rehab training. “PocketECG CRS was built on our PocketECG […]