Regulatory: Page 72

InSightec submits PMA for ExAblate Neuro
By AuntMinnie.com staff writers
MR-guided focused ultrasound developer InSightec has submitted a premarket approval (PMA) application to the U.S. Food and Drug Administration for its ExAblate Neuro device for treating essential tremor.
October 21, 2015
SonaCare lands FDA nod for HIFU system
By AuntMinnie.com staff writers
High-intensity focused ultrasound (HIFU) developer SonaCare Medical has received U.S. Food and Drug Administration (FDA) clearance to market its Sonablate 450 system for the ablation of prostate tissue.
October 13, 2015
Penn. governor mandates insurance coverage of DBT
By AuntMinnie.com staff writers
Gov. Tom Wolf of Pennsylvania has announced that digital breast tomosynthesis (DBT), or 3D mammography, will be covered by insurance under existing state law and must be provided to Pennsylvania women at no cost.
October 13, 2015
Gamma Medica receives CE Mark for breast system
By AuntMinnie.com staff writers
Gamma Medica has received a CE Mark for the sale and distribution of its LumaGem molecular breast imaging (MBI) system within the European economic area.
October 12, 2015
Varian's Aria software certified for MU
By AuntMinnie.com staff writers
The Aria oncology information system software from Varian Medical Systems has been certified to demonstrate meaningful use (MU) as part of the U.S. government's healthcare IT stimulus program.
October 8, 2015
Colon cancer group criticizes USPSTF guidelines
By AuntMinnie.com staff writers
A colon cancer awareness group is criticizing this week's decision by the U.S. Preventive Services Task Force (USPSTF) to withhold its endorsement of two colon screening exams -- including CT colonography.
October 8, 2015
FDA OKs changes for InSightec's ExAblate
By AuntMinnie.com staff writers
MR-guided focused ultrasound developer InSightec has received U.S. Food and Drug Administration (FDA) clearance for a new version of its ExAblate device and a change in labeling.
October 8, 2015
ISO certification: Why it's important to you
By Larry Nguyen
While medical device companies often tout International Organization for Standardization (ISO) certifications, potential customers may not understand what these certifications actually prove. But a little due diligence can clear up any uncertainty, writes Summit Imaging CEO Larry Nguyen.
October 8, 2015
2015 10 08 15 34 19 856 Nguyen Larry 200
FDA clears ECG readings on Carestream's Vue Motion
By AuntMinnie.com staff writers
Carestream Health has received clearance from the U.S. Food and Drug Administration (FDA) for diagnostic reading of electrocardiograms (ECGs) on desktop displays and mobile tablets using its Vue Motion viewer.
October 7, 2015
U.S. government finalizes meaningful use regulations
By Erik L. Ridley
With the goal of making its meaningful use IT stimulus initiative simpler and more flexible for providers, the U.S. government has issued final rules for its incentive and certification program for electronic health record software.
October 7, 2015
2015 10 07 16 49 08 80 Computer Stethoscope 200
Advocates for NaF-PET plan rebound from CMS decision
By Wayne Forrest
In a word, "disappointment" is how members of the nuclear medicine and radiology communities are reacting to last month's rejection by the U.S. Centers for Medicare and Medicaid Services (CMS) of a proposal to loosen restrictions on reimbursement for sodium fluoride (NaF) PET scans to detect bone metastases.
October 7, 2015
2015 10 07 15 55 03 265 No Check Vote 200
Varian gets regulatory clearance for VitalBeam
By AuntMinnie.com staff writers
Radiation therapy firm Varian Medical Systems has received 510(k) clearance from the U.S. Food and Drug Administration and the European CE Mark for its VitalBeam radiation therapy system.
October 6, 2015
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