Regulatory: Page 110

Parascript lands PMA for CAD software
By AuntMinnie.com staff writers
Computer-aided detection (CAD) developer Parascript has received U.S. Food and Drug Administration premarket approval (PMA) for version 6.1 of its AccuDetect software.
September 4, 2013
Siemens gets FDA nod for Intevo SPECT/CT
By AuntMinnie.com staff writers
Siemens Healthcare has garnered U.S. Food and Drug Administration 510(k) clearance for its Symbia Intevo SPECT/CT system.
September 4, 2013
ACR urges USPSTF to act on CT lung cancer screening
By AuntMinnie.com staff writers
The American College of Radiology (ACR) is urging the U.S. Preventive Services Task Force (USPSTF) to finalize its draft recommendation on CT lung cancer screening.
August 28, 2013
NY rads to pay $3.6M in false-claims case
By AuntMinnie.com staff writers
Owners of a New York-based radiology practice have agreed to pay $3.57 million to resolve allegations that they submitted false claims for MRI exams.
August 28, 2013
MITA, HIMSS laud vendor disclosure statement
By AuntMinnie.com staff writers
The Medical Imaging and Technology Alliance (MITA) and the Healthcare Information and Management Systems Society (HIMSS) have praised the completion and approval of a manufacturer disclosure statement.
August 25, 2013
InSightec lands Health Canada approval
By AuntMinnie.com staff writers
Focused-ultrasound developer InSightec has received Health Canada approval for its ExAblate system.
August 21, 2013
Navidea reaches agreement with FDA
By AuntMinnie.com staff writers
Radiopharmaceutical developer Navidea Biopharmaceuticals and the U.S. Food and Drug Administration have agreed on protocols for the firm's NAV5001 investigational SPECT imaging agent.
August 21, 2013
Elekta wins clearances for Versa HD upgrade
By AuntMinnie.com staff writers
Radiation oncology firm Elekta has received the CE Mark and clearance from the U.S. Food and Drug Administration for new features for its Versa HD linear accelerator.
August 20, 2013
Given gets PillCam 510(k) clearance
By AuntMinnie.com staff writers
Video-capsule developer Given Imaging has received 510(k) clearance from the U.S. Food and Drug Administration for a new version of its camera-pill technology.
August 19, 2013
Joint Commission seeks to expand imaging standards
By Wayne Forrest
The U.S. Joint Commission has proposed more-stringent requirements in the ambulatory care, critical access hospital, and hospital accreditation programs for facilities that provide CT, MRI, nuclear medicine, and PET services.
August 14, 2013
Verizon gets FDA nod for 1st healthcare product
By AuntMinnie.com staff writers
Telecommunications company Verizon has received U.S. Food and Drug Administration clearance for its first healthcare product, a remote cloud-based patient monitoring service.
August 8, 2013
Hermes gets FDA nod for NM software
By AuntMinnie.com staff writers
Swedish nuclear medicine software developer Hermes Medical Solutions has received U.S. Food and Drug Administration clearance for new software for reconstructing and processing hybrid nuclear medicine (NM) studies.
August 7, 2013
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