Regulatory: Page 262

Barco gets FDA nod for flat-panel mammo
By AuntMinnie.com staff writers
Diagnostic display provider Barco has received Food and Drug Administration 510(k) clearance for its Coronis 5MP Mammo LCD display, according to the Kortrijk, Belgium-based firm.
August 30, 2004
DR Systems gets nod for digital mammo reading
By AuntMinnie.com staff writers
PACS vendor DR Systems has received Food and Drug Administration clearance for diagnostic reading of digital mammography images on its PACS network.
August 30, 2004
FDA approves Siemens FFDM system
By AuntMinnie.com staff writers
Multimodality vendor Siemens Medical Solutions has received FDA premarket approval for its Mammomat Novation DR full-field digital mammography system.
August 22, 2004
Medicsight to bring Lung CAR to market
By AuntMinnie.com staff writers
Image analysis software developer Medicsight has received Food and Drug Administration clearance for its Lung Computed Assisted Reader (CAR) software.
August 15, 2004
Hologic gets FDA nod for SecurViewDX
By AuntMinnie.com staff writers
Women's imaging firm Hologic has received Food and Drug Administration marketing clearance for its SecurViewDX breast imaging workstation, according to the Bedford, MA-based company.
August 11, 2004
Final PMA decisions for July 2004
Each month the U.S. Food and Drug Administration's Center for Devices and Radiological Health (CDRH) releases a final list of premarket approvals (PMA), product development protocols (PDP), supplement and notice decisions from the previous month. The following decisions were rendered for July 2004.
August 11, 2004
Final 510(k) decisions for July 2004
Each month the U.S. Food and Drug Administration's Center for Devices and Radiological Health (CDRH) releases a final list of devices approved for marketing in the U.S. during the previous month. The following is a list of 510(k) final decisions rendered for July 2004:
August 9, 2004
Medicare set to raise outpatient rates
By AuntMinnie.com staff writers
The Centers for Medicare and Medicaid Services (CMS) is proposing a payment rate update and other policy changes in its annual Outpatient Prospective Payment System (OPPS) rule.
August 9, 2004
Varian adds On-Board Imager features
By AuntMinnie.com staff writers
Varian Medical Systems has received Food and Drug Administration 510(k) clearance for a new suite of features on its On-Board Imager system for the Clinac and Trilogy medical linear accelerators. The new features allow On-Board Imager to synchronize image acquisition with a patient's respiratory cycle and automate "marker matching" for more precise tumor targeting, according to the Palo Alto, CA-based vendor.
August 8, 2004
Siemens launches Magnetom C! scanner
By AuntMinnie.com staff writers
Siemens Medical Solutions has received Food and Drug Administration 510(k) clearance for Magnetom C!, a 0.35-tesla C-shaped MRI system that offers 270° of accessibility. The system employs a compact magnet with a pole diameter of 54 inches, and is open on three sides, according to the Malvern, PA-based vendor.
August 5, 2004
CHMP recommends SonoVue reinstatement
By AuntMinnie.com staff writers
Europe's Committee for Human Medicinal Products (CHMP) has recommended reinstating the echocardiography indication for Bracco's SonoVue ultrasound contrast agent.
August 4, 2004
Varian gets OK for dose calculator
By AuntMinnie.com staff writers
Varian Medical Systems has received Food and Drug Administration 510(k) clearance for a new dose calculation algorithm based on AAA techniques. The algorithm improves radiation dose distributions in heterogeneous areas of the body such as the lung, where bone, dense soft tissues, and air pockets each interact with radiation in unique ways, Varian said.
August 2, 2004
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