FDA APPROVED!
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| Agfa HealthCare's Impax Mammography Diagnostic Workstation has been cleared by the FDA. |
The FDA has given clearance to the Impax Mammography Diagnostic Workstation from Agfa HealthCare (Ridgefield Park, NJ). Designed to enhance the way mammography images are retrieved, displayed, archived, and distributed, the Impax system is a multi-modality workstation that delivers "one-stop" review and results distribution for digital breast-imaging studies-all while gaining access to other general imaging exams, and all from a single workstation. The Impax mammography workstation also is cleared as a vendor-neutral solution for regionally approved digital mammography modality vendors.
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| The FDA has cleared a host of new add-ons to Philips' Pinnacle3 radiation therapy planning system. |
Philips Medical Systems (Bothell, Wash) recently received FDA 510(k) clearance for new products available on its Pinnacle3 radiation therapy planning system. The products are designed to improve accuracy and workflow for radiation oncology and facilitate more accurate delivery of radiation to tumors, thereby reducing harm to surrounding healthy tissue. The three new products include Conformal Arc, offering the ability to conform an arc of beams used to kill cancer; physics modeling tools, providing a more precise representation of the linear accelerator's parameters; and sliding-window intensity modulated radiation therapy (IMRT) treatment planning, creating a conformal dose distribution.
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| The RTX3320 PSTN Wireless Telehealth Gateway from RTX Heathcare is now cleared and can be used for home monitoring, e-health, and more. |
The FDA has issued a 510(k) premarket notification clearance to RTX Healthcare (San Jose, Calif) for the company's RTX3320 PSTN Wireless Telehealth Gateway for home monitoring, e-health, and remote disease management applications. The device uses wireless and Internet technologies for automated operation with a minimum need for patient interaction. The system serves as the remote communications link between compatible patient monitors and the compatible healthcare facility at another location.
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| Siemens' Magnatom C! MRI system offers 270° of accessibility and has been FDA cleared. |
Siemens Medical Solutions (Malvern, Pa) has received 510(k) FDA clearance for its Magnetom C!, a C-shaped MRI system. The system offers 270° of accessibility and features a compact, mid-field, C-shaped magnet with one of the smallest pole diameters available-54 inches. Designed for efficiency, the system is open on three sides to permit easy side loading and optimized patient comfort.
Varian Medical Systems (Palo Alto, Calif) has received FDA 510(k) clearance for a new AAA dose calculation algorithm in the company's Eclipse 3-D radiotherapy treatment planning software. The algorithm improves radiation dose distributions in heterogeneous areas of the body, such as the lung, where bone, dense soft tissues, and air pockets interact with radiation in unique ways. Varian also received FDA 510(k) clearance for automated tools in real-time tumor tracking and respiratory gating during image-guided radiotherapy. The tools have been added to the company's On-Board Imager system for Clinac and Trilogy medical linear accelerators. The features enable Varian's On-Board Imager to be the first linac-based kV X-ray digital imaging system that can synchronize image acquisition with a patient's respiratory cycle and automate marker matching for more precise tumor targeting.
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