Regulatory: Page 178

CMS issues final rule on preventive services
By AuntMinnie.com staff writers
The U.S. Centers for Medicare and Medicaid Services (CMS) issued a final rule with comment period that would implement key provisions in the Affordable Care Act of 2010 to expand preventive services for Medicare beneficiaries, improve payments for primary care services, and promote access to healthcare services in rural areas.
November 2, 2010
Varian gets 510(k) for Acuros
By AuntMinnie.com staff writers
Radiation therapy firm Varian Medical Systems has received U.S. Food and Drug Administration 510(k) clearance for its Acuros XB dose-calculation algorithm.
October 31, 2010
GE gets FDA nod for new Vivid E9
By AuntMinnie.com staff writers
GE Healthcare has received U.S. Food and Drug Administration 510(k) clearance for the latest version of its Vivid E9 cardiovascular ultrasound system.
October 31, 2010
IBA gets French OK to market Filtracis
By AuntMinnie.com staff writers
French radiopharmaceutical developer IBA Molecular has received approval to market its Filtracis radiopharmaceutical kit in France.
October 27, 2010
NRC to hear thyroid cancer therapy concerns
By AuntMinnie.com staff writers
The U.S. Nuclear Regulatory Commission (NRC) will hold public hearings in Washington, DC; Los Angeles; and Houston over the next several weeks on radiation safety in healthcare, including outpatient treatment of patients with thyroid cancer.
October 21, 2010
Parascript lands another CE Mark
By AuntMinnie.com staff writers
Computer-aided detection (CAD) developer Parascript has received the European CE Mark for its AccuDetect mammography CAD software.
October 17, 2010
Bartron nets FDA OK for software
By AuntMinnie.com staff writers
Bartron Medical Imaging has received clearance from the U.S. Food and Drug Administration to market its Med-Seg viewer.
October 17, 2010
GE's DaTscan gets European nod
By AuntMinnie.com staff writers
GE Healthcare's SPECT radiopharmaceutical agent DaTscan has been recommended in updated European Federation of Neurological Societies guidelines for the diagnosis and management of Alzheimer's disease.
October 14, 2010
Calypso nets FDA OK on gating feature
By AuntMinnie.com staff writers
Calypso Medical Technologies has received 510(k) clearance from the U.S. Food and Drug Administration to market a new Dynamic Edge gating technology for its Calypso system.
October 11, 2010
Acceletronics, Cablon net FDA OK
By AuntMinnie.com staff writers
Oncology equipment provider Acceletronics and Cablon Medical have received 510(k) marketing clearance from the U.S. Food and Drug Administration for the RAD II KV imager for image-guided radiation therapy.
October 7, 2010
NRC probes Mo-99 snafu at Walter Reed
By AuntMinnie.com staff writers
The U.S. Nuclear Regulatory Commission (NRC) is investigating how Walter Reed Army Medical Center in Washington, DC, allegedly mishandled the delivery of 1.5 Ci of molybdenum-99 (Mo-99) and 71 mCi of thallium-201 by leaving the two packages in the lobby for two days.
October 7, 2010
Siemens launches MRI scanners in U.S.
By AuntMinnie.com staff writers
Siemens Healthcare has received clearance from the U.S. Food and Drug Administration to market two new MRI scanners in the U.S.
October 6, 2010
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