CardioDynamics received market FDA clearance for its new BioZ Impedance Cardiography (ICG) clinical parameters and electronic medical record (EMR) interface capability for its BioZ Dx System.

ProSolv CardioVascular has further enhanced its CardioVascular Image and Information Systems (CVIIS) product line with the integration of Corridor4DM (previously known as 4DM-SPECT) capabilities, allowing clinicians to access 4DM review, analysis and quantification tools from any ProSolv CardioVascular workstation. The enhancement enables nuclear cardiology physicians and technologists to do reporting and image management at reportedly any location, streamlining workflow and improving productivity.

Boston Scientific Corp. released data reflecting experience from the first 15,000 patients monitored wirelessly on the LATITUDE Patient Management System, a device that detects clinical events between scheduled follow-up visits and then sends the clinical event data directly to physicians, reportedly enabling clinicians to observe these events sooner.

The FDA has granted ATS Medical Inc. approval to begin marketing additional sizes of its line of ATS Open Pivot Mechanical Heart Valves, as the company expands its valve product offerings in the U.S. market.
The company has now added 25- and 35-mm mitral valves to its line of U.S. products.

Concentric Medical has obtained FDA 510(k) clearance for its Merci L6 Retriever, a device that restores blood flow to ischemic stroke patients. The Merci Retriever is designed to restore blood flow by engaging, capturing and removing blood clots.

St. Jude Medical Inc. announced FDA approval of its first radiofrequency (RF) wireless devices to treat patients with heart failure and with potentially lethal heart arrhythmias.

The FDA gave ZOLL Medical Corp. clearance to market and sell the ZOLL AED Pro with See-Thru CPR technology, which is designed to help minimize interruptions in CPR, as ZOLL aims to comply with one of the key recommendations of the American Heart Association’s (AHA) Guidelines for Advanced Cardiac Life Support.

Signalife launched the sales of its new, FDA-approved, ambulatory 12-lead ECG cardiovascular monitor, the Fidelity 100.

The Fidelity 100 is a patient module that wirelessly transmits the ECG to a data collection device (laptop), which reportedly can store up to 2500 hours of data. During patient evaluation, a physician can mark events of interest. After the ECG procedure, marked events can be quickly evaluated and data can be stored to flash memory for future evaluation, said the company.

CircuLite Inc. reported the launch of the clinical development program for its Synergy Pocket Circulatory Assist Device with the successful implantation of the first patient in a European feasibility trial. Synergy is a miniature implantable blood pump, the size of a AA battery, that can be implanted superficially in a pocket, like a pacemaker.

Datascope Corp. said that it has developed a new patient monitoring system called NetGuard that monitors the electrical activity of the heart (EKG) in order to protect the unmonitored hospital patient population in the event of a life-threatening heart rhythm.

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