Soft Tissue Transponder for Radiotherapy and Radiosurgery Treatments for Cancer got FDA Approval
Reporter: Aviva Lev-Ari, PhD, RN
Varian Medical Systems ($VAR) scored FDA 510(k) clearance for its soft tissue transponder for radiotherapy and radiosurgery treatments
FDA clears Varian soft tissue transponder to treat cancer
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Varian Medical Systems’ Calypso soft tissue Beacon transponder–Courtesy of Varian |
Varian Medical Systems ($VAR) scored FDA 510(k) clearance for its soft tissue transponder for radiotherapy and radiosurgery treatments.
The Palo Alto, CA-based company’s Calypso soft tissue Beacon transponders are implanted in soft tissue throughout the body, allowing physicians to target high energy treatment beam radiation at tumors without damaging surrounding tissue. The grain-sized device includes a real-time GPS monitoring system that continuously tracks and monitors the position of transponders during radiosurgery.
An earlier version of the product was cleared for use in the prostate and prostatic bed, but the new indication expands the device’s applications for other types of cancer, the company said in a statement. Varian plans to release the transponders toward the end of this year, and expects a full commercial roll-out in 2015.
“We’re pleased to be able to make the system available to clinicians who want to use it more broadly, not just for conventional radiotherapy but for some of the newer approaches, like stereotactic body radiotherapy (SBRT), which involves delivering higher radiation doses very quickly,” Andrea Morgan, Calypso product manager said in a statement. “For treatments like that, accurate targeting is essential, and the new Calypso transponders have an important role to play.”
The FDA nod bodes well for Varian, as the company struggles to recover from a disappointing second quarter. The devicemaker saw its net earnings fall nearly 18% in Q2, with profits of $92.7 million down from $112.8 million the same period last year. Revenue increased 1% to $779 million, primarily due to a 4% jump in oncology sales and a slight uptick in imaging components.
Regulatory blessings also help Varian forge ahead in its emerging markets, where the company sees strong demand for its oncology and medical imaging products. Last year, Varian built its first Asian subsidiary in South Korea, giving it an expanded market for its cancer-treating radiotherapy devices and imaging equipment. In January, the company renewed a three-year, $515 billion deal withToshiba Medical Systems to supply medical imaging components. The companies originally charted the deal in January 2011 for an estimated $450 billion.
Varian Medical Systems
Varian Medical Systems, Inc., of Palo Alto, California, is the world’s leading manufacturer of medical devices and software for treating cancer and other medical conditions with radiotherapy, radiosurgery, and brachytherapy. The company supplies informatics software for managing comprehensive cancer clinics, radiotherapy centers and medical oncology practices. Varian is a premier supplier of tubes, digital detectors, and image processing workstations for X-ray imaging in medical, scientific, and industrial applications and also supplies high-energy X-ray devices for cargo screening and non-destructive testing applications. Varian Medical Systems employs approximately 6500 people who are located at manufacturing sites in North America, Europe, and China and approximately 70 sales and support offices around the world. For more information, visit http://www.varian.com or follow us on Twitter .
– read the release
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