Regulatory: Page 132

FDA to review Hologic breast tomo extension
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration is set to review an application by women's imaging vendor Hologic for an expansion of the clinical indications for its Selenia Dimensions 3D digital breast tomosynthesis mammography system.
August 23, 2012
CMS releases final rule for stage 2 meaningful use
By Erik L. Ridley
The U.S. Centers for Medicare and Medicaid Services (CMS) has released its final rule for stage 2 meaningful use, which now includes the viewing of medical images as a menu item in the U.S. government's healthcare IT stimulus program.
August 22, 2012
Toshiba Aquilion RXL nets FDA clearance
By AuntMinnie.com staff writers
Toshiba America Medical Systems said it has received clearance from the U.S. Food and Drug Administration for its Aquilion RXL CT scanner.
August 22, 2012
3 hepatitis C cases in Kan. linked to Kwiatkowski
By AuntMinnie.com staff writers
Kansas health authorities say they have identified three patients so far who have been infected with a strain of hepatitis C that is closely related to the one found in patients in New Hampshire who are believed to have been infected by former radiologic technologist David Kwiatkowski.
August 22, 2012
FDA clears Toshiba's Titan 1.5-tesla MR scanner
By AuntMinnie.com staff writers
Toshiba America Medical Systems has received clearance from the U.S. Food and Drug Administration for its new Vantage Titan 1.5-tesla MR series of scanners, which includes eight-, 16-, and 32-channel MR systems.
August 21, 2012
Positron gets FDA nod for coronary software
By AuntMinnie.com staff writers
PET vendor Positron said that the U.S. Food and Drug Administration has cleared a software application for coronary flow reserve quantification developed by the University of Texas Health Science Center at Houston.
August 20, 2012
Neusoft nets ISO, CE Mark for Attrius
By AuntMinnie.com staff writers
Neusoft Positron Medical Systems has received International Organization for Standardization (ISO) certification and CE Mark approval for its Attrius PET systems.
August 20, 2012
GE changes Optison labeling
By AuntMinnie.com staff writers
GE Healthcare has modified the patient monitoring and observation requirements for its Optison echocardiography contrast agent.
August 20, 2012
FDA OKs InSightec ExAblate clinical trial
By AuntMinnie.com staff writers
Focused-ultrasound developer InSightec has received approval from the U.S. Food and Drug Administration to begin a phase I clinical trial to evaluate its ExAblate Neuro system for treating patients with tremor-dominant Parkinson's disease.
August 19, 2012
FDA advises imaging for patients with St. Jude leads
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration is recommending that patients who have implantable heart defibrillators that use St. Jude Medical's Riata and Riata ST leads receive x-ray or other imaging exams to check for abnormalities in the insulation surrounding the lead.
August 16, 2012
Siemens gets FDA nod for PET amyloid plaque software
By AuntMinnie.com staff writers
Siemens Healthcare has received U.S. Food and Drug Administration clearance for the use of its syngo.PET Amyloid Plaque software with PET and PET/CT scanners.
August 15, 2012
FDA clears expanded use of Pharmalucence imaging agent
By AuntMinnie.com staff writers
Radiopharmaceutical product supplier Pharmalucence said the U.S. Food and Drug Administration has approved the use of its sulfur colloid injection for localizing lymph nodes in patients with malignant melanoma.
August 15, 2012
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