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Last updated on April 17, 2014 at 17:30 EDT

Latest Center for Devices and Radiological Health Stories

2011-01-18 06:00:00

MOUNTAIN VIEW, Calif., Jan. 18, 2011 /PRNewswire/ -- Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced today that it completed an End-of-Review meeting with the U.S. Food and Drug Administration (FDA or Agency) for the AZ-004 New Drug Application (NDA), and has received the official FDA minutes from the meeting. In December 2010, Alexza held the End-of-Review meeting in response to a Complete Response Letter (CRL) received in October 2010. A CRL is issued by FDA's Center for Drug...

2011-01-13 13:02:00

Company cited for significant manufacturing violations SILVER SPRING, Md., Jan. 13, 2011 /PRNewswire-USNewswire/ -- U.S. Marshals, acting under a court order sought by the U.S. Food and Drug Administration, on Jan. 5 and 6, seized all dental devices from Rite-Dent Manufacturing Corporation, located in Hialeah, Fla. (Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO) The seizure of dentistry products valued at $208,910 follows an FDA inspection that found significant...

2010-11-15 12:22:00

Safety concerns on the devices that treat abnormal heart rhythms also to be addressed SILVER SPRING, Md., Nov. 15, 2010 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today announced a program aimed at facilitating the development of safer, more effective external defibrillators used to treat abnormal heart rhythms through improved design and manufacturing practices. (Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO) (Logo:...

2010-11-09 08:39:00

SILVER SPRING, Md., Nov. 9, 2010 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration has been investigating reports that patients undergoing computed tomography (CT) brain perfusion scans were accidently exposed to excess radiation. The FDA found that when properly used, the CT scanners did not malfunction. Instead, it is likely that the improper use of the scanners resulted in these overdoses. However, the FDA has identified a series or promising steps to enhance the safety...

2010-11-04 09:15:00

Devices capturing digital image of breasts to be Class II SILVER SPRING, Md., Nov. 4, 2010 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today announced that it is easing the pathway to market for mammography systems that produce computerized X-ray images of the entire breast. (Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO) (Logo: http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO) These systems, known as Full Field Digital Mammography Systems, are an...

2010-10-26 06:07:00

SAN DIEGO, Oct. 26 /PRNewswire-FirstCall/ -- Aethlon Medical, Inc. (OTC Bulletin Board: AEMD), the pioneer in developing therapeutic filtration devices to address infectious disease and cancer, announced today that it has retained Miriam C. Provost, Ph.D. of the Biologics Consulting Group, Inc. to be the company's U.S. regulatory advisor. (Photo: http://photos.prnewswire.com/prnh/20090325/LA88762LOGO-b) (Photo: http://www.newscom.com/cgi-bin/prnh/20090325/LA88762LOGO-b) Miriam has over...

2010-10-18 12:47:00

HACKENSACK, N.J., Oct. 18 /PRNewswire/ -- ReGen Biologics Inc. is taking exception to the FDA's Center for Devices and Radiological Health's (CDRH) Thursday announcement of a plan to rescind the 510(k) clearance of the company's Menaflex knee implant. "For CDRH to arrive at the decision that the device has a new intended use four years after two senior CDRH officials informed the company that the device could be reviewed through the 510 (k) program is totally unbelievable," said Gerald E....

2010-10-14 13:03:00

Decision follows re-evaluation of scientific evidence SILVER SPRING, Md., Oct. 14 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today announced that an orthopedic device used in the knee should not have been cleared for marketing in the United States. The announcement follows a re-evaluation of the scientific evidence that was undertaken after a September 2009 agency report identified problems in the agency's review of the device. (Logo:...

2010-10-11 05:30:00

MOUNTAIN VIEW, Calif., Oct. 11 /PRNewswire-FirstCall/ -- Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced today that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA or Agency) regarding its New Drug Application (NDA) for AZ-004 (Staccato® loxapine), submitted as Adusuve(TM) Staccato® (loxapine) inhalation aerosol, 5 mg and 10 mg. A CRL is issued by FDA's Center for Drug Evaluation and Research...

2010-08-04 08:00:00

Recommendations focus on innovation, regulatory predictability, and patient safety SILVER SPRING, Md., Aug. 4 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today issued two comprehensive evaluations containing recommendations that address three key objectives of the agency's public health mission as it relates to medical devices - foster device innovation, create a more predictable regulatory environment, and enhance device safety. (Logo:...