Researchers at the University of Washington have used machine learning to teach an AI system to identify when someone is having a cardiac arrest. The system learned to identify agonal breathing, which occurs when someone gasps for breath during cardiac arrest, with a high degree of accuracy. The technology can be embedded into a variety […]
Tag: Cardiology
Mimics Enlight Cardiovascular Planning Software Gets FDA Clearance
Materialise, a 3D printing company with a focus on patient-specific parts, has received FDA clearance for its Mimics Enlight cardiovascular planning software suite. The product’s initial application will be in planning complex transcatheter mitral valve replacement (TMVR) procedures. Developed with the help of the Henry Ford Health System in (Read more...)
EmoGraphy by Philips Monitors and Predicts Stress: Interview with Navin Natoewal
Philips has recently launched EmoGraphy, a stress management technology to measure someone’s stress levels and then predict them an hour into the future. The company worked out the sensing and algorithm calculation methods, and are now licensing their technology to firms that want to expand it into their devices. We met with Navin Natoewal, t (Read more...)
Project Moray Developing Robotic Intracardiac Catheter for Complex Interventions
Catheter-based surgical interventions are now routine, so much so that navigating to the heart from an access site in the groin is considered ho-hum. Once there, though, getting a catheter tip to the exact spot within the heart that requires treatment can still be exceedingly difficult. Unlike the vasculature used to get there, the heart […]
(Read more...)Meril Myval Transcatheter Aortic Valve Cleared in Europe
Meril Life Sciences, a company based in India, has obtained the European CE mark of approval for its Myval transcatheter aortic heart valve. This marks the first such approval for an Indian company, highlighting how far the country’s medical device industry has advanced in the past few years. The Myval features a hybrid honey comb […]
Octopus-Inspired Wearable Biosensor Sticks to Wet and Dry Skin
Researchers from Daegu Gyeongbuk Institute of Science and Technology (DGIST) in South Korea have developed a new waterproof, wearable biosensor that can stick to the skin in a unique way. Their work, recently published in ACS Applied Materials and Interfaces, demonstrates the biosensor adheres to the skin in wet and dry conditions and can monitor [ (Read more...)
GORE CARDIOFORM Approved by FDA to Treat Atrial Septal Defects
The GORE CARDIOFORM Septal Occluder has been approved by the FDA to treat ostium secundum atrial septal defects (ASD) via percutaneous closure procedures. In a clinical study of the device in 125 patients with ASD, ranging in age from 2 to 84, all who successfully received the implant maintained the closure when evaluated six months […]
StethoMe At-Home Stethoscope for Detection of Respiratory Issues in Kids Cleared in Europe
StethoMe, a company headquartered in Poznań, Poland, just won the European CE mark for its eponymous digital stethoscope and accompanying software that analyzes recorded sounds for signs of respiratory problems. StethoMe is intended to be used by parents to check on their kids when there are signs of sickness. Instead of immediately bringing t (Read more...)
WatchPAT One, a Fully Disposable At-Home Sleep Apnea Test, FDA Cleared
Itamar Medical, a firm based in Israel, won FDA clearance for its brand new WatchPAT One system for at-home sleep apnea testing. The system is based on the previously cleared WatchPAT 300 device, but it’s fully disposable and is therefore is not reused between patients, helping to prevent any infections. The WatchPAT One pairs with […]
(Read more...)Patches Made of Heart Tissue Going to Clinical Trials
Stem cell therapies to heal damaged hearts have proven to be lacking so far, probably because simply injecting new cells into afflicted regions isn’t enough. Researchers from Imperial College London have now created patches made of cardiac tissue to sew over damaged areas of the heart. These patches, which can beat on their own to […]
IMPEDE-FX Embolization Plug Cleared in U.S. for Peripheral Arteries
Shape Memory Medical, a company out of Santa Clara, California, won FDA clearance for its IMPEDE-FX Embolization Plug. The new device is to be used as an adjunct to the firm’s IMPEDE Embolization Plug, which is already FDA cleared. The two devices have been developed to cause deliberate obstructions or to reduce blood flow in […]
New Device Monitors Blood Flow Through Radial Artery to Prevent Occlusions Post PCI
Following transradial percutaneous coronary interventions (PCI), the radial artery can occasionally occlude, potentially resulting in serious complications. Radial occlusion is treated by applying compression, but clinicians have no idea whether nor how much blood is flowing through the artery. Moreover, once an occlusion happens in the radial arte (Read more...)
Philips Unveils IntraSight Multi-Modality Imaging Platform
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 (Read more...)
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 f (Read more...)
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 implantatio (Read more...)
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 (Read more...)
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 (Read more...)
FDA Approves More Accurate GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System
Gore just announced winning FDA approval for its GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System. The thoracic endovascular aortic repair system is based on the Conformable GORE TAG Device, but with a new, more robust control mechanism that helps to position the implant with greater accuracy and confidence. The implant its (Read more...)
Stereotaxis Unveils New Magnetic Robotic Cardiac Navigation System
Stereotaxis, a company that has developed robotic magnetic navigation technology to deliver catheters to the heart during ablation procedures, is introducing its latest generation system. The new Stereotaxis Genesis RMN platform features smaller magnets that can rotate around their center of mass, and which are positioned inside robotic arms that c (Read more...)
AliveCor Introduces World’s First 6-Lead Consumer ECG, the KardiaMobile 6L
AliveCor, founded by Dr. David Albert, is the company that introduced reliable and useful ECG monitoring to consumers. Their products, which operate as basic single-lead ECG devices, have been cleared by the FDA to be able to detect cardiac arrhythmias, including atrial fibrillation, tachycardia, and bradycardia. They have been quite limited still, (Read more...)