Over the past decade there have been several advancements in prothrombin time (PT)/international normalized ration (INR) point-of-care testing (POCT) devices. This is usually performed at an outpatient Coumadin clinic or at the physician’s office, which can be inconvenient for patients, so there is a growing trend toward patient self-testing (PST) devices.  

July 12, 2012 — BioControl Medical has announced U.S. Food and Drug Administration (FDA) approval to begin the second phase of INOVATE-HF (Increase Of Vagal Tone in Heart Failure), a global, multi-center, investigational device exemption (IDE) clinical study of the company’s CardioFit system for heart failure.

July 12, 2012 — Terumo Interventional Systems, a strategic business unit of Terumo Medical Corporation, a U.S. subsidiary of Terumo Corporation, announced the completion of U.S. patient enrollment in the Occlusive/StenoticPeripheral Artery Revascularization Study (OSPREY) designed to evaluate the safety and effectiveness of the Misago self-expanding stent system.

July 12, 2012 — Cardiac Science Corporation announced it will provide data from its Quinton Q-Tel Rehabilitation Management Systems to the American Association of Cardiovascular and Pulmonary Rehabilitation's (AACVPR) Outpatient Cardiac Rehabilitation Registry.

 

July 11, 2012 — Ultrasonix Medical Corporation has received approval from the U.S. Food and Drug Administration (FDA) for its SonixGPS technology for vascular access procedures.

July 11, 2012 — Lantheus Medical Imaging Inc., a developer, manufacturer and distributor of diagnostic imaging agents, announced the publication of results from the CaRES (Contrast Echocardiography Registry for Safety Surveillance) multicenter safety registry for its ultrasound imaging agent Definity Vial for (Perflutren Lipid Microsphere) Injectable Suspension.

July 11, 2012 — Biotronik, a manufacturer of innovative medical technology, announced that enrollment is now complete for the much anticipated SPIRIT-ICD study, with 503 patients from 37 sites in 11 countries worldwide registered.

July 11, 2012 — St. Jude Medical received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the ViewFlex Xtra intracardiac echocardiography (ICE) catheter.

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