EchoNous announced that it has received the Eurepean CE Mark of approval for its Kosmos platform, an ultrasound and AI-based software system that helps physicians obtain diagnostic imaging and make clinical decisions at the bedside. The Kosmos platform consists of an eight-ounce ultrasound device, the Kosmos Torso, which also has ECG and digital auscultation functions. […]
Tag: Cardiology
COVID-19 and PPE: Some of Us Will Die
A storm is coming, and the new fear is the shortage of personal protective equipment, warns John Mandrola, MD, of the COVID19 pandemic as some hospitals bar physicians from complaining. Medscape
Respirix for Non-Invasive Cardiopulmonary Monitoring: Interview with CEO Eric Kriegstein
For patients with cardiopulmonary illnesses such as chronic obstructive pulmonary disease (COPD or congestive heart failure (CHF), few technologies exist to effectively monitor and manage their conditions in a convenient way. Pulmonary artery catheters and implants, that can help with monitoring, have successfully reduced heart failure hospitalizations, but these implants are highly invasive and costly. […]
TriGUARD 3 Wins CE Mark for Cerebral Protection During Transcatheter Heart Procedures
Keystone Heart Ltd. announced that is has received the European CE Mark for its TriGUARD 3, a device designed to minimize the risk of cerebral damage by deflecting embolic debris away from cerebral circulation during transcatheter aortic valve implantation and other transcatheter heart procedures. According to the announcement, the TriGUARD 3 device is now the only product […]
Stereotaxis Genesis Robotic Magnetic Navigation System Cleared in U.S.
Stereotaxis, with offices in St. Louis, MO and the Netherlands, has won FDA clearance for the Genesis RMN System, a new generation of the company’s robotic navigation systems for the delivery of magnetic ablation catheters to address cardiac arrhythmias. The system can access all chambers of the heart and coronary vasculature, and can also be […]
Advanced Wireless Neonatal Body Monitors to Improve Outcomes
Babies that end up in the neonatal intensive care unit (NICU) or pediatric intensive care unit (PICU) are monitored via a complex collection of sensors, each of which has a wire connected to a patient monitor. While necessary, all this technology makes it difficult for parents to bond with their children and for clinicians to […]
Biobeat Receives EU Clearance for Vital Sign Monitoring with Wristwatch and Patch
Biobeat announced recently that it has received CE Mark approval for its patch and wristwatch that non-invasively measure blood pressure, cardiac output, stroke volume, blood oxygenation, and heart rate. The Israel-based company’s platform monitors vital signs in real-time using wireless, non-invasive, medical-grade technology, and uploads these data points into the cloud through either a smartphone or […]
ProtEmbo for Reducing Strokes Caused by TAVR Procedures: Interview with Founders
During transcatheter aortic valve replacements (TAVR), there is a risk of cerebrovascular events due to embolic debris breaking off from vessel walls and migrating to the brain. While microembolization during the procedure is a universal phenomenon, the majority of patients experience no symptoms. However, a clinically-evident stroke is a serious and feared complication. Protembis is […]
Masimo Receives FDA Approval for Continuous RRp Monitoring
Masimo announced that it received FDA clearance for continuous RRp (respiration rate from the photoplethysmograph) monitoring with its with Rad-97, Radical-7, and Radius-7 Pulse Co-Oximeters. Usually, monitoring respiration rate involves manually counting breaths with a timer or using chest straps that need to be fitted. The newly-approved Masimo RRp monitor allows clinicians to conveniently measure respiration […]
V-Wave Shunt for Relief of Heart Failure Symptoms Cleared in EU
Heart failure patients often suffer from high pressure within the left side of their hearts, which can lead to difficulties breathing and other debilitating conditions. V-Wave, an Israeli firm, won the European CE Mark of approval for its Ventura interatrial shunt that aims to regulate left atrial pressure by creating a passage for blood to […]
ClotChip Receives FDA Breakthrough Device Designation for Real-Time Coagulation Testing
Cleveland-based XaTek Inc. announced receiving FDA Breakthrough Device designation for ClotChip, a handheld device that can measure a patient’s bleeding risk profile from a single drop of blood. The main advantage of ClotChip is that it produces results in 15 minutes, versus the many hours that traditional lab work currently takes. The dramatic decrease in […]
Abbott’s FlexNav Cleared in EU to Deliver Portico Transcatheter Aortic Valve
Abbott announced that it received the EU CE Mark for the new FlexNav delivery system for the company’s Portico transcatheter aortic valve. Transcatheter aortic valve replacement (TAVR) is a minimally invasive procedure for patients diagnosed with aortic stenosis, a condition which restricts blood flow through the valve. TAVR is particularly important as an alternative to […]
Jewel Wearable Cardioverter Defibrillator Could Help Prevent Sudden Cardiac Deaths
In the United States sudden cardiac death (SCD) claims 325,000 lives every year. SCDs are due to abnormalities in the conducting system of the cardiac tissue, resulting in arrhythmias, and can often occur after cardiac surgeries and other treatments. SCDs are medical emergencies, as cardiopulmonary resuscitation and defibrillation must be administered as soon as possible. […]
Table-Top Robot Uses AI to Make Blood Draws, Insert Catheters
Researchers at Rutgers University have developed a robot that utilizes artificial intelligence, along with near-infrared and ultrasound imaging, to automatically make blood draws and insert catheters in small blood vessels. The device could take the guesswork out of blood draws, which are frequently challenging when performed manually, and reduce the chances of complications, while allowing […]
Cardiovalve Wins FDA Breakthrough Device Designation for Transcatheter Tricuspid Valve Replacement System
Cardiovalve announced that it received FDA Breakthrough Device Designation for its Transcatheter Tricuspid Valve Replacement System. The company also received approval for an Early Feasibility Study of the device for tricuspid and mitral valve regurgitation indications. The Cardiovalve transcatheter system is designed for treatment of mitral and tricuspid regurgitation by replacement of the native valves via […]
RESPMETER Opioid Overdose Detector Wins FDA Breakthrough Device Status
Altair Medical recently announced that it received FDA Breakthrough Device status for its RESPMETER wearable biosensor. The biosensor is a chest-worn wireless sensor that can detect Opioid Indused Respiratory Depression (OIRD), a common and often fatal side effect of using opioid drugs. The biosensor monitors respiratory patterns and analyses them using proprietary algorithms. When the […]
New HydroPICC Prevents Clogged Central Line Catheters
Access Vascular, based in Bedford, Massachusetts, won FDA clearance for the latest version of its HydroPICC anti-thrombogenic central line catheter. As with the original, which was cleared two years ago, the new device features Access’s unique “bulk-hydrophilic” material that prevents clogging by being rich in water while carrying a neutral surface charge. Proteins and other […]
FDA Clears First Pulse Oximeter to Measure Breathing Rate
Masimo just received the first FDA clearance for a fingertip pulse oximeter that can measure respiration rate. The MightySat Rx spot-check pulse oximeter includes a technology known as Respiration Rate from the Pleth (RRP) that makes it unnecessary to perform manual counts or use chest electrodes to measure respiration rate. The device can be used […]
Abbott’s Gallant Cardiac Implants Cleared in Europe
Abbott won clearance in the European Union for its new Gallant implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) implants. The MRI compatible devices, which Abbott claims have an extended battery lifetime, can securely communicate with patients and physicians via Abbott’s myMerlinPulse smartphone app. Physicians can monitor their patients, including being able to […]
Novalung FDA Cleared to Provide Long-Term Lung Failure Treatment
Critically ill patients with acute respiratory or cardiopulmonary failure who are on long-term mechanical ventilation too often suffer a variety of side effects. These can include ventilator associated lung injury, pneumonia, and diaphragm dysfunction. Moreover, related sedation and lack of movement can aggravate an already difficult situation. To help address these challenges, the FDA has […]