Regulatory: Page 89

FDA seeks injunction against ultrasound gel maker
By AuntMinnie.com staff writers
Fearing infections from poor packaging practices, the U.S. Food and Drug Administration is seeking a permanent injunction to ban ultrasound gel manufacturer Pharmaceutical Innovations and its chief executive from manufacturing or selling products until they comply with FDA requirements.
October 5, 2014
Koning secures Australian breast CT clearance
By AuntMinnie.com staff writers
Koning has received the Australian Register of Therapeutic Goods Certificate for its Koning Breast CT system and biopsy add-on option.
October 2, 2014
FDA clears Esaote's MyLab Gamma ultrasound unit
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration has cleared ultrasound vendor Esaote North America's MyLab Gamma ultrasound scanner.
October 1, 2014
FDA releases device cybersecurity guidance
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration has finalized its vendor guidance for the management of cybersecurity in medical devices.
October 1, 2014
FDA: 3D breast imaging demands 3D display
By AuntMinnie.com staff writers
New imaging technologies such as 3D mammography are changing how doctors find and diagnose disease. But they're also sparking the need for display technology that allows images to be viewed in 3D, according to the U.S. Food and Drug Administration.
September 30, 2014
MindwaysCT gets 510(k) for bone density software
By AuntMinnie.com staff writers
MindwaysCT has received 510(k) clearance from the U.S. Food and Drug Administration to market a new version of its software that acquires bone mineral density measurements from CT images.
September 30, 2014
FDA reopens comments on social media rules
By AuntMinnie.com staff writers
Responding to requests for additional time, the U.S. Food and Drug Administration has reopened the comment period for two draft guidances on the use of social media in connection with medical devices and drugs.
September 25, 2014
FDA to harmonize fluoro guidelines
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration has issued a draft of new rules designed to harmonize U.S. and international requirements for fluoroscopy equipment.
September 24, 2014
Seno wraps up enrollment for Imagio trial
By AuntMinnie.com staff writers
Optoacoustic imaging developer Seno Medical Instruments said it has finished enrolling patients in a study of its Imagio breast imaging system.
September 23, 2014
GE gets FDA nod for Discovery IQ PET/CT system
By AuntMinnie.com staff writers
GE Healthcare has received U.S. Food and Drug Administration 510(k) clearance for its Discovery IQ PET/CT system.
September 22, 2014
FDA grants orphan designation to Navidea's Lymphoseek
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration has granted orphan drug designation to Navidea Biopharmaceuticals' Lymphoseek radiopharmaceutical agent for use in sentinel lymph node detection in patients with head and neck cancer.
September 18, 2014
FDA clears Siemens' Somatom Scope CT scanner
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration has cleared Siemens Healthcare's Somatom Scope, a 16-slice CT scanner.
September 17, 2014
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