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Regulatory: Page 91
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Ultrasound contrast developer Acusphere has voluntarily withdrawn a regulatory application in Europe for its Imagify ultrasound contrast agent for the detection of coronary artery disease.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
Medicaid payments may influence cancer screening rates
By
AuntMinnie.com staff writers
In states with higher Medicaid payments for office visits, beneficiaries were more likely to be screened for breast, cervical, and colorectal cancer, according to a study published online in the journal
Cancer
.
August 24, 2014
VuCOMP gets breast CAD clearance in Turkey
By
AuntMinnie.com staff writers
Computer-aided detection (CAD) developer VuCOMP has received approval to market its M-Vu CAD and M-Vu Breast Density software in Turkey.
August 21, 2014
IMRIS wins Health Canada licensing for Visius
By
AuntMinnie.com staff writers
IMRIS has received Health Canada licensing to incorporate its next-generation MRI core technology into its Visius surgical theater for sales and marketing in the country.
August 20, 2014
FDA clears Philips' TAVI package
By
AuntMinnie.com staff writers
Philips Healthcare has received 510(k) clearance from the U.S. Food and Drug Administration to market its planning application for transcatheter aortic valve implantation (TAVI) treatments.
August 20, 2014
Aeolus submits IND for radiation protection drug
By
AuntMinnie.com staff writers
Aeolus Pharmaceuticals has filed an investigational new drug (IND) application with the U.S. Food and Drug Administration to begin a phase I study of a radiation protection drug.
August 20, 2014
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