Regulatory: Page 111

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
CMS issues final 'cost-centers' rule
By AuntMinnie.com staff writers
The U.S. Centers for Medicare and Medicaid Services (CMS) on August 2 implemented its controversial new policy changing the way it accounts for costs in its hospital inpatient prospective payment system.
August 5, 2013
MITA takes issue with IPPS final rule
By AuntMinnie.com staff writers
The Medical Imaging and Technology Alliance (MITA) is criticizing the U.S. Centers for Medicare and Medicaid Services' inpatient prospective payment system (IPPS) final rule.
August 5, 2013
Philips gets FDA nod for rad therapy planning module
By AuntMinnie.com staff writers
Philips Healthcare has received 510(k) clearance from the U.S. Food and Drug Administration for its Pinnacle3 proton treatment planning module.
August 4, 2013
GE takes aim at breast tomosynthesis market
By Kate Madden Yee
GE Healthcare has long been one of the top two mammography firms, but the company until now hasn't had an offering in the cutting-edge breast tomosynthesis segment. That is changing, however: The firm has begun shipping its SenoClaire tomosynthesis system in Europe and has put the final touches on a regulatory application in the U.S.
August 4, 2013
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Hologic gets FDA nod for single-energy femur scan
By AuntMinnie.com staff writers
Women's imaging vendor Hologic has received U.S. Food and Drug Administration (FDA) approval for its single-energy femur exam, which detects atypical femur fractures on a dual-energy x-ray absorptiometry (DEXA) bone densitometer.
August 1, 2013
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