Items added to the FDA's Center for Devices and Radiological Health website within the last month. http://www.fda.gov/cdrh/newpg.html en-us Tue, 22 May 2012 09:24:39 GMT webo@cdrh.fda.gov http://www.fda.gov/cdrh/images/homepg/c-d-r-h.gif http://www.fda.gov/cdrh/ The purpose of this public meeting is to discuss clinical study design considerations and performance metrics for innovative glucose sensors intended to be used in hospital point of care settings. Mon, 21 May 2012 04:00:00 GMT http://www.gpo.gov/fdsys/pkg/FR-2012-05-21/html/2012-12180.htm FDA is seeking input from the clinical community, academia, Government, industry, clinical laboratories, and other stakeholders regarding clinical validation studies and performance criteria for innovative hospital glucose sensors... Mon, 21 May 2012 04:00:00 GMT http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm304483.htm The following explains the process for requesting speakers from the Center for Devices and Radiological Health (CDRH) to participate in meetings, conferences, and workshops which are being sponsored by outside organizations... Fri, 18 May 2012 04:00:00 GMT http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/ucm304631.htm Learn more Wednesday, May 23, 2012 at 2:00 p.m. ET, when FDA's Center for Devices and Radiological Health (CDRH) will host a 30-minute Webinar to discuss basic information on Hearing Aids. Tue, 15 May 2012 04:00:00 GMT http://www.fda.gov/AboutFDA/Transparency/Basics/ucm304193.htm FDA is announcing the following public meeting on the draft guidance. This guidance will apply to x-ray computed tomography, general and dental radiography, and diagnostic and interventional fluoroscopy devices. FDA has organized this meeting to solicit.. Thu, 10 May 2012 04:00:00 GMT http://www.gpo.gov/fdsys/pkg/FR-2012-05-10/html/2012-11262.htm This draft guidance document outlines FDA's current thinking on information that should be provided in premarket notifications for x-ray imaging devices with indications for use in pediatric populations. FDA intends for this guidance to minimize... Thu, 10 May 2012 04:00:00 GMT http://www.gpo.gov/fdsys/pkg/FR-2012-05-10/html/2012-11260.htm The FDA is alerting people with MS to the risks of serious injuries and death associated with procedures to treat chronic cerebrospinal venous insufficiency (CCSVI). Furthermore, the benefits of these experimental procedures have not been proven... Thu, 10 May 2012 04:00:00 GMT http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm303318.htm The FDA is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Wed, 09 May 2012 04:00:00 GMT http://www.gpo.gov/fdsys/pkg/FR-2012-05-09/html/2012-11179.htm This guidance document outlines the FDA's current thinking on information that should be provided in premarket notifications for x-ray imaging devices with indications for use in pediatric populations. The Agency intends for this guidance to minimize... Wed, 09 May 2012 04:00:00 GMT http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm300850.htm Like all medical procedures, computed tomography (CT), fluoroscopy, and nuclear medicine imaging... Wed, 09 May 2012 04:00:00 GMT http://www.fda.gov/Radiation-EmittingProducts/RadiationSafety/RadiationDoseReduction/default.htm Medical imaging has led to improvements in the diagnosis and treatment of numerous medical conditions in children and adults. There are many types - or modalities - of medical imaging procedures that are used on children, each of which uses different... Wed, 09 May 2012 04:00:00 GMT http://www.fda.gov/Radiation-EmittingProducts/RadiationEmittingProductsandProcedures/MedicalImaging/ucm298899.htm The main purpose of the workshop is to discuss the draft guidance Pediatric Information for X-ray Imaging Device Premarket Notifications. This guidance will apply to x-ray computed tomography, general and dental radiography, and diagnostic and... Wed, 09 May 2012 04:00:00 GMT http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm301989.htm The EXCOR® Pediatric VAD is a blood pump that vibrates rhythmically and is designed to assist patients who cannot pump enough blood with their own natural heart. The device can be used in patients who cannot effectively pump blood with their left and/or.. Tue, 08 May 2012 04:00:00 GMT http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm302715.htm The purpose of the public workshop is to provide information about FDA's Medical Device Quality Systems Regulation (QSR) to the regulated industry, particularly small businesses. Mon, 07 May 2012 04:00:00 GMT http://www.gpo.gov/fdsys/pkg/FR-2012-05-07/html/2012-10893.htm As part of the Mammography Quality Standards Act (MQSA), Congress mandated there be annual reporting of adverse actions taken against mammography facilities. Congress stipulated that the report be made available to physicians and the general public and... Thu, 03 May 2012 04:00:00 GMT http://www.fda.gov/Radiation-EmittingProducts/MammographyQualityStandardsActandProgram/Reports/ucm302760.htm Labeling, Approval Order, and Summary of Safety and Effectiveness for Presillion plus CoCr Coronary Stent on RX System (P110004). Tue, 01 May 2012 04:00:00 GMT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/pma/pma.cfm?num=P110004 The Presillion plus CoCr Coronary Stent on RX System is a metal stent that is mounted on a folded balloon attached to a catheter delivery system for placement into a blood vessel supplying blood to the heart (coronary artery). The stent is made of a... Tue, 01 May 2012 04:00:00 GMT http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm302534.htm On June 13, 2012, the committee will discuss, make recommendations and vote on information related to the premarket approval application for the Edwards SAPIEN Transcatheter Heart Valve sponsored by Edwards Lifesciences. The Edwards SAPIEN Transcatheter.. Fri, 27 Apr 2012 04:00:00 GMT http://www.gpo.gov/fdsys/pkg/FR-2012-04-27/html/2012-10156.htm The BOND? ORACLE? Human Epidermal Growth Factor Receptor 2 (HER2) Immunohistochemical (IHC) System is a laboratory test that measures how much HER2 protein is being made by breast cancer cells. The test uses a technique that will specifically recognize.. Wed, 25 Apr 2012 04:00:00 GMT http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm301469.htm Labeling, Approval Order, and Summary of Safety and Effectiveness for BONDTM ORACLETM Human Epidermal Growth Factor Receptor 2 (HER2 ) Immunohistochemical (IHC) System (P090015). Wed, 25 Apr 2012 04:00:00 GMT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/pma/pma.cfm?num=P090015 Labeling, Approval Order, and Summary of Safety and Effectiveness for Epic? Vascular Self-Expanding Stent System (P110035). Wed, 25 Apr 2012 04:00:00 GMT http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/pma/pma.cfm?num=P110035 The Epic? Vascular Self-Expanding Stent System is a thin, flexible, metal mesh tube that is implanted in the large arteries that supply blood to the pelvis and legs (iliac arteries). It consists of two parts, the stent and the delivery system. The stent.. Wed, 25 Apr 2012 04:00:00 GMT http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm301463.htm New page listing of the Companion Diagnostics that have been approved by CDRH. Wed, 25 Apr 2012 04:00:00 GMT http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/ucm301431.htm With certain types of plasma samples, doctors may receive a falsely low result (up to a maximum of 50% lower than the actual concentration of Troponin I). These incorrect results may cause serious adverse health consequences, including death. Tue, 24 Apr 2012 04:00:00 GMT http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm301461.htm