Regulatory: Page 200

Michelson gets nod for OCT scanner
By AuntMinnie.com staff writers
Michelson Diagnostics has won the CE Mark for clinical use of its VivoSight optical coherence tomography (OCT) scanner in Europe, in addition to nonclinical use worldwide.
September 17, 2009
FDA clears ImaSight DR sensor
By AuntMinnie.com staff writers
Digital radiography (DR) product developer ImaSight has received clearance from the U.S. Food and Drug Administration for its ImaSight 4600 DR sensor.
September 15, 2009
Hansen nets FDA OK, shows new products
By AuntMinnie.com staff writers
Robotic technology developer Hansen Medical has received U.S. Food and Drug Administration clearance for its next-generation Sensei X robotic catheter system.
September 15, 2009
Abbott to bring Xience V to China
By AuntMinnie.com staff writers
Abbott Laboratories has received Chinese State Food and Drug Administration clearance for its Xience V everolimus-eluting coronary stent system.
September 13, 2009
St. Jude gets clearance for EnSite Velocity
By AuntMinnie.com staff writers
Cardiac technology developer St. Jude Medical has received U.S. Food and Drug Administration clearance for its EnSite Velocity cardiac mapping system.
September 13, 2009
IMRIS gets FDA nod
By AuntMinnie.com staff writers
Canadian intraoperative MRI technology developer IMRIS has received U.S. Food and Drug Administration 510(k) clearance for its IMRISNV and IMRIScardio products.
September 7, 2009
FDA OKs Hologic's MammoSite ML
By AuntMinnie.com staff writers
Women's imaging vendor Hologic has received 510(k) clearance from the U.S. Food and Drug Administration for the company's MammoSite ML breast brachytherapy system.
September 1, 2009
Number of U.S. mammo facilities drops
By AuntMinnie.com staff writers
The number of mammography facilities accredited by the U.S. Food and Drug Administration continued its slow decline in the agency's most recent reporting period.
September 1, 2009
NeuroLogica gets nod for SPECT unit
By AuntMinnie.com staff writers
Portable scanner developer NeuroLogica has received U.S. Food and Drug Administration 510(k) clearance for its inSPira HD portable high-resolution SPECT scanner.
August 31, 2009
SuperSonic gets FDA nod for Aixplorer
By AuntMinnie.com staff writers
Ultrasound developer SuperSonic Imagine has received U.S. Food and Drug Administration 510(k) clearance for its Aixplorer ultrasound scanner.
August 25, 2009
FDA OKs Intelerad PET/CT product
By AuntMinnie.com staff writers
PACS vendor Intelerad Medical Systems has received 510(k) clearance from the U.S. Food and Drug Administration to market and distribute its PET/CT Image Fusion product.
August 19, 2009
HHS releases breach notification rules
By AuntMinnie.com staff writers
The U.S. Department of Health and Human Services (HHS) has issued new regulations that require healthcare providers, health plans, and other entities covered by HIPAA to notify individuals when their health information is breached.
August 19, 2009
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