The U.S. Food and Drug Administration (FDA) said it is amending the classification regulation for electrocardiograph (ECG) electrodes into a class II device category, exempting these devices from FDA clearances. This rule is effective as of Aug. 22, 2011.

July 21, 2011 – The U.S. Food and Drug Administration (FDA) today approved AstraZeneca’s blood-thinning drug ticagrelor (Brilinta) to reduce cardiovascular death and heart attack in patients with acute coronary syndromes (ACS). The new class of antiplatelet therapy drug offers greater benefits over the current standard of clopidogrel (Plavix). The new drug is also the first with the ability to have its effects reversed quickly, reducing bleeding complications if a patient requires surgery or suffers trauma.

 

 

July 21, 2011 – Concentric Medical Inc. announced the launch of the expanded family of Merci Retrievers in Japan for the treatment of ischemic stroke. With the addition of the V 2.0 Soft and V 3.0 Soft, through recent Ichihen Approval, the entire family of V Series Merci Retrievers are now approved and reimbursed in Japan. The Merci Retriever is a catheter-based medical device that stroke centers use to remove blood clots from the brains of patients suffering an ischemic stroke.


In a closely watched move viewed as a big step toward a paradigm shift in how heart valves are repaired in the United States, a U.S. Food and Drug Administration (FDA) advisory panel voted late yesterday to recommend approval of the Edwards Lifesciences Sapien transcatheter heart valve. The FDA Circulatory System Devices Panel recommended the valve specifically for the treatment of patients who are too sick to undergo the standard therapy of surgical valve replacement.

April 26, 2011 – The U.S. Food and Drug Administration (FDA) announced this week it cleared Boston Scientific’s Ion paclitaxel-eluting coronary stent system. 

The stent, available for use with monorail or over-the-wire delivery systems, is made of platinum chromium (PtCr) alloy designed specifically for coronary stenting and intended to improve the acute performance of coronary stent implantation in the treatment of coronary artery disease.  The stent’s alloy and design offer greater strength, enhanced deliverability and exceptional visibility.  The thin-strut stent is designed for improved conformability, minimal recoil, and uniform lesion coverage and drug distribution

July 20, 2011 –ScImage recently launched PicomCloud, a complete, self-service cloud picture archiving and communication system (PACS) for radiology, cardiology and other clinical specialties.

July 20, 2011 — IDEV Technologies Inc. announced the completion of enrollment in the SUPERB trial, a U.S. Food and Drug Administration (FDA)-approved IDE trial evaluating the use of IDEV's Supera stent system for treatment of peripheral artery disease (PAD) in the superficial femoral artery (SFA). Enrollment was completed in May, making SUPERB one of the fastest-enrolling SFA trials.

July 20, 2011 — Ziehm Imaging reports a huge increase in demand for its training programs. In 2010 alone, the number of participants doubled for technical courses given by the mobile C-arm manufacturer.

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