Regulatory: Page 90

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
EOS gets FDA nod for new 3D software
By AuntMinnie.com staff writers
EOS Imaging has received U.S. Food and Drug Administration 510(k) clearance for version 1.6 of its sterEOS 3D imaging software.
September 17, 2014
IMRIS gets FDA nod for head fixation accessory
By AuntMinnie.com staff writers
IMRIS has received U.S. Food and Drug Administration 510(k) clearance for its new neurosurgical head fixation device rocker arm.
September 11, 2014
ONC publishes final EHR certification criteria
By AuntMinnie.com staff writers
Under a new final rule released on Thursday, the U.S. government has chosen not to proceed with its proposed voluntary 2015 Edition Electronic Health Record (EHR) certification criteria for the meaningful use program.
September 10, 2014
Regulation should keep health IT safe without slowing innovation
By Dr. David Hirschorn
The U.S. Food and Drug Administration's proposal to revise its regulation of mobile medical apps reflects the rapidly changing world of medical software, according to Dr. David Hirschorn, who previews his upcoming presentation at the New York Medical Imaging Informatics Symposium on September 18.
September 7, 2014
2014 09 05 16 20 22 178 Hirschorn David 175 20140905232044
Interstate medical licenses move ahead
By Erik L. Ridley
Physicians seeking to practice telemedicine in other states may soon find the licensure process much easier to navigate with the release on September 5 of model legislation that individual states can use to enact their own laws.
September 4, 2014
Previous Page
Page 90 of 303
Next Page