Regulatory: Page 88

Seno touts reader study ruling out breast cancer
By AuntMinnie.com staff writers
Seno Medical Instruments released study results indicating that its Seno Imagio breast imaging system improves physicians' ability to rule out breast cancer, compared with traditional ultrasound alone.
November 2, 2014
FDA clears Elekta gating tool for prostate cancer
By AuntMinnie.com staff writers
Elekta has received 510(k) clearance from the U.S. Food and Drug Administration for its Response automatic gating technology for prostate cancer.
November 2, 2014
FDA clears Agfa's CR, DR cesium-based detectors
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration has cleared Agfa HealthCare's DXD Imaging package, which includes cesium bromide needle-based image plates for computed radiography (CR) devices and cesium iodide detectors for digital radiography (DR) units.
October 29, 2014
Concord approved for rad therapy center in China
By AuntMinnie.com staff writers
Concord Medical Services has received government approval to establish a freestanding radiotherapy cancer center in Datong, China.
October 27, 2014
RaySearch gets FDA nod for new RayStation
By AuntMinnie.com staff writers
RaySearch Laboratories has received U.S. Food and Drug Administration 510(k) clearance for version 4.5 of its RayStation software.
October 27, 2014
FDA clears new version of Siemens ultrasound scanner
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration has cleared a new version of Siemens Healthcare's Acuson SC2000 cardiovascular ultrasound device.
October 15, 2014
Konica Minolta gets FDA OK for new AeroDR version
By AuntMinnie.com staff writers
Konica Minolta Medical Imaging has received U.S. Food and Drug Administration clearance for its AeroDR XE wireless digital radiography (DR) system.
October 14, 2014
JAMA IM editorials weigh in on lung cancer screening
By Eric Barnes
With Medicare on the cusp of a momentous decision about whether to pay for CT lung cancer screening, the issue is the focus of a pair of editorials published October 13 in JAMA Internal Medicine. Taking opposite sides, the articles one last time outline positions that have become solidified as the U.S. government weighs what could be one of the biggest public health initiatives in decades.
October 12, 2014
Bracco gets FDA nod for ultrasound contrast agent
By Erik L. Ridley
A third contestant has joined the U.S. market for ultrasound contrast agents: On Friday, Bracco Diagnostics received U.S. Food and Drug Administration approval for its Lumason ultrasound contrast agent. The approval marks the end of a long odyssey for Bracco in its efforts to bring the agent to market.
October 9, 2014
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FDA clears tumor segmentation software
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration has cleared tumor segmentation software developed by Columbia University and licensed to Varian Medical Systems.
October 9, 2014
Kubtec gets FDA nod for breast specimen tomo
By AuntMinnie.com staff writers
Kubtec has received U.S. Food and Drug Administration clearance for its Mozart with TomoSpec breast specimen radiography and tomosynthesis system.
October 6, 2014
CMS reopens MU hardship exception
By AuntMinnie.com staff writers
The U.S. Centers for Medicare and Medicaid Services (CMS) said it will once again accept hardship exception applications to enable healthcare provides to avoid penalties for not meeting meaningful use (MU) criteria.
October 6, 2014
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