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Daniel Schultz, MD, acting director of the FDAs Center for Devices and Radiological Health (CDRH) since April, last month had the acting term removed from his title by acting FDA Commissioner Lester Crawford. In announcing the appointment of Schultz to head CDRH, the agencys medical device unit, Crawford said he brings to our medical device program the ideal combination of skills, experience and temperament to ensure that FDAs medical device program is second to none.
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While working in the ED one night, a nurse noticed a strange feeling around her left cheek.
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CompuMed (Los Angeles, California), a medical informatics company serving healthcare with diagnostic software solutions, said that it has been awarded a five-year renewal of its contract to provide electrocardiogram (ECG) interpretation systems and services for the New York State Department of Correctional Services (NYDOCS). NYDOCS will purchase a minimum of 87 new CardioGram systems along with ongoing ECG remote interpretation services.
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Escalon Medical (Wayne, Pennsylvania) reported that the board of Drew Scientific Group (London) has recommended that its shareholders accept Escalons revised exchange offer.
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Acusphere (Watertown, Massachusetts) said last month that it has entered into a collaboration, license and supply agreement with Nycomed (Roskilde, Denmark) for the European development and marketing rights to Acuspheres lead product candidate, AI-700, an ultrasound contrast agent currently in Phase III clinical trials for assessing myocardial perfusion in the diagnosis of coronary heart disease.
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After drug-eluting stents, the cardiovascular device that has attracted the most headlines and interest over the past two years is probably the ventricular assist device (VAD), a small pump seeing growing use for bridge to heart transplant or even as a destination application.
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St. Jude Medical (St. Paul, Minnesota) finally received its invitation from the FDA in late June to the cardiac resynchronization therapy defibrillator (CRT-D) party. While the late arrival joined the festivities nearly two years after competitors Guidant (Indianapolis, Indiana) and Medtronic (Minneapolis, Minnesota), it said it doesn't plan to enter the scene quietly and already has begun an aggressive rollout of the product in the U.S.
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New developments in medical technology are often commercialized in the European market prior to their introduction in the U.S., due to the more rapid regulatory approval process and receptivity of physicians in Europe to new technologies, particularly in the interventional device segment.
