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Regulatory: Page 90
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
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
Esaote nets FDA OK for MyLab Six scanner
By
AuntMinnie.com staff writers
Esaote North America has received 510(k) clearance from the U.S. Food and Drug Administration for its MyLab Six ultrasound system.
September 3, 2014
Ill. revokes mammo license of Chicago center
By
AuntMinnie.com staff writers
The state of Illinois has revoked a Chicago imaging center's license to perform mammography after finding that the facility was failing to provide patients with reports in a timely manner.
September 3, 2014
GE's Vizamyl gets European OK
By
AuntMinnie.com staff writers
GE Healthcare has received clearance from the European Commission to market Vizamyl.
September 1, 2014
GE gets FDA nod for SenoClaire breast tomosynthesis
By
AuntMinnie.com staff writers
GE Healthcare has received approval from the U.S. Food and Drug Administration for its SenoClaire digital breast tomosynthesis system.
September 1, 2014
CMS relaxes EHR meaningful use rules
By
AuntMinnie.com staff writers
A new rule published by the U.S. Department of Health and Human Services on August 29 gives healthcare providers more flexibility in how they use electronic health record (EHR) technology to meet meaningful use standards in 2014.
September 1, 2014
Acusphere pulls European bid for Imagify contrast
By
AuntMinnie.com staff writers
Ultrasound contrast developer Acusphere has voluntarily withdrawn a regulatory application in Europe for its Imagify ultrasound contrast agent for the detection of coronary artery disease.
August 27, 2014
ACR cries foul as DNA test beats CTC to Medicare approval
By
Eric Barnes
The American College of Radiology (ACR) is crying foul after the U.S. Centers for Medicare and Medicaid Services recently approved a stool DNA test for colorectal cancer screening -- as reimbursement for CT colonography (CTC) continues to languish.
August 27, 2014
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