Varian Medical Systems Receives FDA Clearance for New Radiotherapy Planning Software

l3qg8epp Varian Medical Systems Receives FDA Clearance for New Radiotherapy Planning Software
Varian Medical Systems, Inc., Palo Alto, CA, developed a new radiotherapy planning tool that automates and accelerates the treatment planning process. The smart segmentation knowledge-based contouring tool works with the company’s earlier released Eclipse planning software.The Eclipse treatment planning system includes contouring and field set up, with the added benefit of 4D visualization throughout the process. Eclipse displays the motion of targets and critical structures using specially designed 4D tools. With Smart Segmentation Knowledge Based Contouring, two techniques are combined to make the contouring process as quick and accurate as possible. The ‘Smart Segmentation’ will automatically identify and visually outline organs and other anatomical structures. ‘Knowledge Based Contouring’ will accelerate the process by matching pre-contoured images from a database with those of the patient. mka6ncv9 Varian Medical Systems Receives FDA Clearance for New Radiotherapy Planning SoftwareThe Knowledge Based Contouring tool contains an anatomy atlas that covers all of the areas of the body most commonly treated with radiotherapy.

Jefferson Amacker, director, clinical solutions commented:

In order to create a customized treatment plan, a clinician must take the patient’s anatomical images and identify and outline the tumor and nearby organs in a process called contouring.  This is critical when specifying what is to be irradiated or protected during radiotherapy treatments. Traditionally, contouring has been a time-consuming process. Remodeling is generally faster because you have something to work from. Both of these tools give clinicians a head start, so that the contouring task can be more easily and quickly completed.

Press release: Varian Medical Systems Receives FDA 510(k) Clearance for Software that Speeds Up Radiotherapy Treatment Planning …

Product page: Varian IKOE knowledge-based Segmentation …

Varian Medical Systems Updates Radiotherapy Devices to Deliver Higher Doses

Varian Medical Systems Updates Radiotherapy Devices to Deliver Higher Doses

Varian Medical Systems, Inc., a Palo Alto, California firm, received FDA clearance to update the control software of the Clinac and Trilogy targeted radiotherapy devices and for the new Pivotal Care Solution for prone breast treatment. This enables a higher intensity dose delivery, up to 2400 monitor units per minute, and better support for treating breast cancer in the prone position.

The technology can now facilitate treating breast cancer patients on their stomachs rather than their backs—an approach that can reduce the volume of lung and heart tissue exposed to radiation during treatment.

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BSD-2000 Hyperthermia System Receives FDA HDE Marketing Approval

BSD-2000 Hyperthermia System Receives FDA HDE Marketing Approval

BSD Medical has received FDA Humanitarian Device Exemption (HDE) marketing approval for its BSD-2000 Hyperthermia System for the treatment of cervical cancer.

The system uses focused electromagnetic energy to apply therapeutic heating to deep-seated tumors that are located more than 3 cm under the skin surface.

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Siemens SOMATOM Definition AS Open CT Approved in U.S.

Siemens SOMATOM Definition AS Open CT Approved in U.S.

Siemens received FDA clearance to begin marketing its SOMATOM Definition AS Open CT scanner in the U.S.

According to Siemens literature, this is not just a general purpose CT system, but this SOMATOM was specifically engineered to be a tool for contouring and planning in preparation for interventional and radiation therapy procedures.

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Hitachi Proton Beam Therapy Coming to Mayo Clinic

Hitachi Proton Beam Therapy Coming to Mayo Clinic

Hitachi got an order from the Mayo Clinic for two of its Proton Beam Therapy (PBT) systems.  The giant setup, which the company claims is “40 percent smaller than that of the conventional system,” involves installing a particle accelerator and four patient treatment rooms, plus one for research.  The advantage of PBT is that hydrogen nuclei can be aimed precisely to hit the tumor so that almost all the energy is delivered to the target, sparing healthy tissue in the beam’s path.

From the announcement:

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Navotek’s RealEye System for Prostate Cancer Treatment Cleared by FDA

Navotek's RealEye System for Prostate Cancer Treatment Cleared by FDA

When we last covered Navotek Medical‘s RealEye patient tracking system, it was in its early stages of development. Now, MedCityNews reports that the system has been granted FDA 510(k) approval, clearing the way for Navotek to begin manufacturing and selling the system in the US. The RealEye is designed as an add-on to traditional linear accelerators which are currently used to administer radiation therapy, and allows doctors to track a patient’s movement during treatment in order to minimize damage to the healthy tissues surrounding the cancerous one.
From the product page:

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Using Gold Nanoparticles to Detect Circulating Tumor Cells

Using Gold Nanoparticles to Detect Circulating Tumor Cells

Our modern armamentarium for treating cancer is impressive, but sometimes, despite our best treatments, tumor cells continue to lurk in the bloodstream, seeding metastases throughout the body. Researchers at Emory have developed a way to monitor for these circulating tumor cells using gold nanoparticles.
This technique has been used before, but difficulty was encountered because white blood cells are close to the same size as some tumor cells, so they would both be tagged, necessitating a laborious multi-antibody staining process.

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Varian Proton Radiation Therapy System Gets Regulatory Clearance in U.S.

Varian Proton Radiation Therapy System Gets Regulatory Clearance in U.S.

Varian Medical Systems out of Palo Alto, California received FDA 510(k) clearance for its proton beam radiation therapy system. The certification means that hospitals do not need to seek individual clearances to install the Varian system.
Proton therapy has the advantage of delivering energy to a tumor with minimal effect on healthy tissue on the way from the gun to the target, but the disadvantage that it’s really, really expensive. Pictured above is the gantry where the patient is subjected to the beam, and below is the beam path coming from the cyclotron that can supply a number of patient treatment rooms at the same time. Further down the page is the image of the finished patient treatment room.

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Lung Optimized Treatment Now Option on CyberKnife in US

Lung Optimized Treatment Now Option on CyberKnife in US

Accuray Inc., maker of the CyberKnife radiosurgery system, has received FDA 510(k) clearance for Lung Optimized Treatment, a new component of CyberKnife that allows for accurate lung tracking without using fiducial markers.

Lung Optimized Treatment offers the accuracy and steep dose fall off required to safely treat lung tumors, even those close to such critical structures. Simulation and comparison workflows, combined with unique tracking modes, allow the clinician to select from multiple, non-invasive options, providing lung SBRT patients the optimal non-invasive treatment option, regardless of tumor location.

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