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Regulatory: Page 68
Carestream submits 510(k) for conebeam CT scanner
By
AuntMinnie.com staff writers
Carestream Health has filed a 510(k) application with the U.S. Food and Drug Administration (FDA) for clearance of its Carestream OnSight 3D extremity imaging system.
March 23, 2016
Indiana passes breast density law
By
AuntMinnie.com staff writers
Indiana has become the 25th U.S. state to enact a mandatory breast notification law, according to patient advocacy group Are You Dense Advocacy.
March 23, 2016
Canadian keepsake ultrasound firm hit for security lapse
By
AuntMinnie.com staff writers
Canadian keepsake ultrasound provider UC Baby has discontinued its on-demand prenatal video service for customers after an investigation by
CBC News
found it was easy to access ultrasound scans conducted at any of its 27 clinics across the country.
March 17, 2016
FDA OKs ACR's digital mammo manual
By
AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) has approved the American College of Radiology's (ACR) alternative standard request for use of the new Digital Mammography Quality Control (QC) Manual and Digital Mammography QC Phantom in routine QC of digital equipment.
March 8, 2016
FDA OKs Spellman's high-frequency x-ray generators
By
AuntMinnie.com staff writers
Spellman High Voltage has received clearance from the U.S. Food and Drug Administration (FDA) to market its family of high-frequency x-ray generators.
March 2, 2016
FDA clears Medtronic's MR surgical leads
By
AuntMinnie.com staff writers
Device manufacturer Medtronic has received clearance from the U.S. Food and Drug Administration (FDA) for its Specify SureScan MR surgical leads for implanted neurostimulation systems for chronic pain.
March 2, 2016
ACR urges Congress to pass CT colonography coverage
By
AuntMinnie.com staff writers
Patient and provider groups are joining the American College of Radiology (ACR) in urging Congress to pass Medicare coverage of CT colonography.
March 2, 2016
Elekta gets FDA nod for radiation dose tracker
By
AuntMinnie.com staff writers
Radiation oncology firm Elekta has received clearance from the U.S. Food and Drug Administration (FDA) for a new radiation dose tracker for use with intensity-modulated radiation therapy and volumetric modulated arc therapy.
March 1, 2016
NEC wins FDA clearance for tomosynthesis display
By
AuntMinnie.com staff writers
NEC Display Solutions of America has received clearance from the U.S. Food and Drug Administration (FDA) for its MultiSync MD211G5 monitor for use in tomosynthesis applications and digital mammography.
March 1, 2016
FDA clears Orpheus Medical's clinical video platform
By
AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) has cleared Orpheus Medical's new clinical video and imaging documentation platform, which also includes a mobile application.
February 29, 2016
Joint Commission posts new diagnostic imaging rules
By
AuntMinnie.com staff writers
The Joint Commission has released new requirements for diagnostic imaging services that are applicable to hospitals and critical access facilities.
February 24, 2016
Senate confirms Califf as FDA chief
By
AuntMinnie.com staff writers
The U.S. Senate on February 24 confirmed Dr. Robert Califf as commissioner of the U.S. Food and Drug Administration (FDA).
February 24, 2016
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