01 May FDA okays new GE tomography system
Waukesha, Wis. — GE Healthcare has received federal approval for yet another medical device technology, and this one promises better imaging for the estimated 20% of Americans that are considered obese.
The company announced Thursday it has received clearance from the Food and Drug Administration for its new wide bore computed tomography (CT) system, which is used in radiation therapy. The system is designed to meet growing demand for better resolution, power, and speed in the imaging of overweight patients for radiation therapy and planning.
According to GE, versatility is what sets this system apart from past radiation oncology imaging devices. While CT is favored by many clinicians because of its ability to adapt, it had one limitation. Overweight patients were unable to undergo a CT scan because of the limitation of existing systems to accurately image them.
The new CT addresses that. Billed as the “world’s most powerful 16-slice wide bore CT system,” the technology will be available in two configurations. The LightSpeed RT16 will enable advanced imaging for radiation therapy planning, and the LightSpeed Xtra is a 16-slice CT scanner designed for radiology needs like trauma, and interventional and bariatric procedures.
With an extra-large 80 cm opening for better patient positioning, the company said the LightSpeed RT16 gives clinicians the freedom to see and access the patient’s entire anatomy.
The patient population served by this new device is, well, sizable. The American Obesity Association reports that more than 20 percent of the U.S. population is obese, and six million Americans are morbidly obese. The latter is defined as more than 100 pounds above the recommended body weight.
The FDA’s approval of the wide-bore system marks the third significant advance introduced this year by GE Healthcare, a $15 billion unit of General Electric Co.
Earlier, GE Healthcare announced the integration of 4D imaging and planning to enable oncologists to see the precise location of tumors and critical structures in motion.
Last week, GE was granted approval for a digital mammography system that produces a better image for the detection of breast cancer.