Boston Scientific won FDA approval for its LOTUS Edge Aortic Valve System for transcatheter valve replacements. It’s indicated for people with severe aortic stenosis who are poor candidates for open heart surgery, but as is the case these days with other transcatheter heart valves, it’s bound to be heavily used off-label. Unlike other t (Read more...)
Tag: Cardiology
AliveCor Consumer ECG Now Spots Bradycardia, Tachycardia, and AFib
AliveCor, the company that introduced practical and useful consumer ECG devices to the market, just got FDA clearance for its KardiaMobile monitor to detect bradycardia and tachycardia. The device has already been cleared to help identify the existence of atrial fibrillation (AFib), but now it can spot abnormally slow or fast heart rhythms. So far, (Read more...)
3D-Printed Heart From Patient’s Own Tissues
Researchers from Tel Aviv University in Israel have developed a 3D printing approach to create a heart with a patient’s own cells. The investigators used patient-derived cellular and acellular material obtained from fatty tissue, along with a unique bioprinter, to 3D-print a heart. The team isolated cells from a patient tissue sample and used (Read more...)
Tyto At-Home Telemedicine Solution Rolling Out Through Best Buy
Tyto Care and Best Buy have partnered up to release one of the more interesting at-home medical devices to come out in the last few years. The TytoHome Medical Exam Kit provides a true telehealth capability by letting parents, caretakers, and people themselves perform physical exams. While the exams are done by average folks, the […]
Tack System for Repair of Angioplasty Endovascular Tears FDA Approved
Balloon catheters have revolutionized the treatment of vascular diseases, but when they’re used to push plaque against the walls of vessels tears can form. These tears can have significant impact on the integrity and hemodynamics of vessels and therefore on the health of patients. Stents can be used to address these, but stents are typically (Read more...)
Spry Health Continuous Wrist-Worn Pulse Oximeter, Heart and Lung Meter FDA Cleared
Spry Health, a Silicon Valley company, won FDA clearance to introduce its Loop System continuous health monitor. The product, which consists of a wrist-band wearable device, charging cradle, and platform to analyze the readings, provides clinical-grade pulse oximetry, heart rate, and breathing rate of a patient over the entire day. Patients can hav (Read more...)
LIFEPAK CR2 Defibrillator Reads ECG During Chest Compressions, FDA Approved
Stryker won FDA approval to introduce its LIFEPAK CR2 defibrillator with LIFELINKcentral program manager. It was developed by Physio Control, now a subsidiary of Stryker. The interesting capability of this automatic external defibrillator (AED) is that it is able to analyze the stricken patient’s electrocardiogram (ECG) while someone is perfo (Read more...)
BIOTRONIK Releasing in U.S. Its Lifesaving PK Papyrus Stent for Treating Coronary Perforations
BIOTRONIK is releasing in the United States its PK Papyrus covered coronary stent, the first new device in many years to be used as an emergency therapy for acute coronary perforations. Because so few of these are expected to be used, but are expected to save many lives, the FDA issued a Humanitarian Use Device […]
Butterfly iQ Multi-Purpose Pocket-Sized Ultrasound Now Available in Europe
Butterfly Network, a company based in Connecticut, finally won the CE mark and is releasing in Europe its Butterfly iQ portable ultrasound system. The product consists of a transducer that plugs right into an iPhone or iPad via the Lightning port, and uses a matching app to display live images, change settings, and review previously […]
BIOTRONIK Releases Carnelian Support Catheter to Help Treat Difficult Peripheral Lesions
Calcified and tortuous peripheral vasculature can be very difficult to get instruments into, even before therapy can be administered. BIOTRONIK is releasing a new device specifically designed for exchange and support of guidewires within the peripheral vessels, which the company claims will allow physicians to access sites that were otherwise (Read more...)
Vector Flow Imaging Used to See Blood Flow in Humans for First Time
Vector flow imaging (VFI) is a technology that utilizes ultrasound to visualize the direction and speed of blood flow, independent of the orientation of the ultrasound probe. It works in any direction and at any angle, but its application in clinical practice has been slow because of limitations of the technology. Now researchers at the […]
FDA Approves First New Therapy to Treat Heart Attacks in Years
Heart attacks are typically treated by placing stents at the sites of narrowing coronary arteries. This has become a standard of care and advances in cath lab technologies allows interventional cardiologists to accurately place stents in a matter of minutes. Now another option, called SuperSaturated Oxygen (SSO2), is being made available thank (Read more...)
FluoroShield Reduces Radiation Exposure from Fluoroscopes, Gets FDA Clearance
Radiation reduction continues to be an important goal in electrophysiology labs, cath labs, and other interventional rooms. To advance this mission, the FDA just gave clearance to Omega Medical Imaging, a company out of Sanford, Florida, for its FluoroShield radiation exposure reduction system. The FluoroShield uses a very fast collimator coupled w (Read more...)
CardioFlux Magnetocardiography System with Faraday Analytical Cloud FDA Cleared
Genetesis, a company based in Mason, Ohio, won FDA clearance for its cardiac imaging offering that combines the CardioFlux magnetocardiograph with the the integrated Faraday Analytical Cloud (FAC). The technology is intended to be used by ER physicians and cardiologists to quickly assess patients presenting with chest pain, helping with triage (Read more...)
Electronic Pajamas Detect Heart Beats, Breathing, Posture Through The Night
How well we sleep makes a big difference to our cardiovascular health, emotional state, and overall well being. Knowing whether the sleep we’re getting is of high quality, and how to improve it, can be very useful to a large chunk of the population. Engineers at University of Massachusetts, Amherst have now developed a pajama […]
Aktiia’s Cuffless Blood Pressure Monitor is Accurate for Months
It doesn’t need recalibrating often. The Aktiia PulseWatch optical blood pressure monitor was tested in six healthy volunteers and agreed with a traditional inflating-cuff blood pressure monitor (Omron M6) two months after the initial calibration. The PulseWatch was accurate to within 1 ± 7 mmHg, which satisfied the 5±8 mmHg gui (Read more...)
Masimo’s Rad-67 Pulse CO-Oximeter with Hemoglobin Spot-Check Cleared by FDA
Masimo just obtained FDA clearance for its Rad-67 Pulse CO-Oximeter with Spot-check Next Generation SpHb monitoring technology and the rainbow DCI-mini Reusable Sensor. The device can be used for quick noninvasive hemoglobin measurement and features the Masimos’s own Measure-through Motion and Low Perfusion SET pulse (Read more...)
Eko DUO Stethoscope with ECG Built-In Now Available for Purchase
Eko, a company that makes advanced and innovative stethoscopes that we really like, is now releasing its Eko DUO combination stethoscope/ECG device. The Eko DUO works along with a paired smartphone or tablet, allowing a physician to simultaneously record heart sounds and ECG (single lead) tracings at the point of care. The DUO makes it […]
Quantra QPlus System for Rapid Coagulation Analysis Wins FDA de novo Approval
HemoSonics, based in Charlottesville, Virginia, won FDA de novo approval for its Quantra QPlus System and accompanying QPlus cartridge for point-of-care coagulation analysis. The system provides easy and rapid coagulation status, requiring only about a minute of labor from clinicians for each test. Initial results are available in about five m (Read more...)
HeartLight X3 System for Rapid and Accurate Cardiac Ablation Procedures Cleared in Europe
Ablation of cardiac tissue is one of the most common ways of treating atrial fibrillation. Interventional cardiologists have to work quite a bit to make sure the energy they’re delivering hits the correct areas. The HeartLight X3 System from CardioFocus is designed to make this process much faster and it has just been approved in […]