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 procedure therefore requires coherently combining all the information […]
Tag: Cardiology
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 from the monitor, […]
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 implantation […]
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 analysis to spot ventricular arrhythmias, ventricular ectopic beats, […]
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 coil-reinforced hydrophilic-coated distal segment. […]
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 itself is the […]
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 can move in a very […]
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, as the power […]
Software Listens to Stethoscope to Classify Heart Sounds: Now FDA Cleared
eMurmur, a Canadian firm, just won FDA clearance for its eMurmur ID system that spots and classifies heart murmurs, as well as S1, S2 heart sounds. The offering, the core of which resides in the cloud, relies on sounds recorded using a third-party electronic stethoscope. The user simply pairs a Bluetooth-capable stethoscope to a smartphone […]
BioSig Technologies Announces First Clinical Cases with PURE EP System: Interview with Ken Londoner, CEO
BioSig Technologies has developed the PURE EP electrophysiology information system, a product that aims to provide better tools for doctors who are treating potentially deadly arrhythmias. The computerized system is used to process electrophysiological signals and provides capabilities to acquire, store, amplify, measure, and display such signals. By aiming to improve data quality and handling […]
Cardiovascular Patch to Limit Damage After Heart Attack
Researchers from Brown University have utilized computational models to design a new viscoelastic patch to reduce damage to heart tissue after a heart attack. They utilized a special blend of starch to help provide mechanical support to the heart tissue, which typically stretches after heart attack and results in poor heart function. “Part of the […]
Tempo Lead Temporary Heart Trans-Surgical Pacing Lead Cleared in EU
BioTrace Medical, a small company headquartered in Menlo Park, California, announced that its Tempo Lead temporary intracardiac pacing lead has been cleared in Europe under the CE Mark. The device is intended for cardiac procedures that require external pacing, such as during transcatheter valve replacements, and it is the only active fixation temporary lead anywhere […]
SentreHEART Wins EU Clearances for LARIAT LAA Closure System
SentreHEART, based in Silicon Valley, won the European CE mark for its LARIAT-RS 50mm percutaneous left atrial appendage (LAA) closure device. The LARIAT-RS is currently the only product available in Europe that is not an implant, but really a procedure, to fully and permanently close the LAA. In addition to the LARIAT-RS 50 mm being […]
Abbott Releases Confirm Rx Insertable Heart Monitor
Abbott is finally launching its Confirm Rx insertable cardiac monitor, a device that received FDA clearance and European regulatory approval back in 2017. The implant is inserted via a small incision during an outpatient procedure, not even requiring a suture to stitch it up. Following, it is able to communicate with a paired-up smartphone via […]
Surgical Robot Autonomously Navigates Inside Heart
Transcatheter heart surgeries, particularly to repair failing valves, are now common in many high-end hospitals. Though the actual replacement procedure is not easy, navigating to the valve site through narrow vasculature and inside the heart is in itself a challenging task. Moreover, pushing guidewires and catheters through the vessels requires fluoroscope imaging, exposing patients and […]
Attain Stability Quad MRI SureScan, World’s Only Active Fixation Left Heart Lead, Approved in U.S.
Cardiac resynchronization therapy (CRT) devices are implanted into heart failure patients to try to improve the efficiency of the heart. How well the therapy ends up working depends very much on the positioning of the electrodes of the leads that stretch into the heart. Quadripolar leads, having two more electrodes than typical, provide a great […]
BIOTRONIK’s Single Lead, Dual Chamber Acticor ICDs and CRT-Ds Coming to U.S.
BIOTRONIK is releasing in the United States its Acticor line of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). These include the Acticor DX and CRT-DX, both of which can take advantage of the company’s Plexa ProMRI S DX lead. A single Plexa ProMRI S DX lead is capable of providing dual-chamber diagnostic […]
AcQMap Heart Mapping Technology Gets EU and US Green Lights
Acutus Medical, a Carlsbad, California company, won European approval for its AcQMap contact mapping software. The company also won FDA clearance for its second generation AcQMap platform to be sold in the United States. The technology, used during cardiac ablation procedures, creates volumetric images of the atrial anatomy using ultrasound At the same time, contact-free […]
Guerbet’s SeQure and DraKon Peripheral Microcatheters Cleared in Europe
Guerbet, a French firm, won European regulatory approval to introduce its SeQure and DraKon peripheral microcatheters on the continent. The devices are indicated for infusion of contrast media, drugs, and embolic materials as part of vascular embolization procedures. The devices were originally developed by Accurate Medical Therapeutics, an Israeli firm that Guerbet purchased. Both the […]
Virtue Sirolimus-Eluting Balloon Helps Prevent Restenosis without Stents
When plaques cause arterial vessels to narrow, intravascular balloons are usually used to widen the lumen. Sirolimus and its analogues are drugs that are commonly used to prevent restenosis. Because blood flows rapidly through, stents coated with the drug have been used to treat the area by slowly releasing sirolimus and the like into the […]