Kyle Myers

Medical devices such as magnetic resonance imaging technology, ultrasound machines and CT scans are used to create images of the human body for medical procedures and to diagnose a wide range of ailments from cancer and heart problems to Alzheimer’s and Parkinson’s diseases.

The reliability of the information gleaned from these devices depends on a number of factors—the quality of the images, the diagnostic methods used to assess those images and the skill of the radiologists who interpret the information.

As director of research in imaging and applied mathematics at the Food and Drug Administration (FDA), it is Dr. Kyle Myers’ job to develop the precise standards needed to test and approve medical imaging devices to ensure they provide doctors and patients with the most accurate information possible.

“The impact of her work is absolutely on all of us. Every one of us has medical images, and we want to be sure that the instruments taking the measures are up to snuff and that the images are presented to the patient and radiologist in the best way possible,” said Dr. Harrison Barrett, professor of optical sciences, mathematics and radiology at the University of Arizona.

In the past three years, Myers has made major advances in the setting of assessment standards for the radiological image quality of new state-of-the-art technology, including 3D breast imaging systems, computer-assisted diagnosis algorithms for detecting lung, breast and colon cancers, and for images sent remotely via smart phone applications.

“Her work is cutting-edge and critical,” said Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health. “Her research is helping to bring new technologies to market.”

Shuren said that in developing assessment standards for medical imaging technologies, Myers is helping to better detect medical problems and reduce the possibility of missed diagnoses.

“Traditionally, the diagnosis only has been as good as the skill of the person reading the film. People are great pattern recognizers, but they are fallible,” said Shuren. “Her work has improved the ability to diagnose disease. She’s improved the accuracy of radiological diagnostic tests, thereby helping to get the right people life-saving treatment.”

In addition to helping ensure quality and accuracy, Myers heads a joint FDA-industry working group that has found ways to assess image quality while lowering radiation doses in CT scans by approximately 50 percent, thereby reducing possible adverse effects.

“No radiation-based imaging technology is without risk, but Kyle’s team is working with industry to bring down the level of radiation in CT scans, and that is huge because about 60 million people have a CT scan as part of a medical diagnostic every year,” said Dr. Steven Pollack, director of the FDA Office of Science and Engineering Laboratories.

Pollack also said Myers was instrumental in the FDA’s February 2011 approval of the country’s first smart phone-based medical image viewing system.

“Her team’s work helped to ensure that we could trust that the conditions on a phone were adequate to read an image,” said Pollack. “Everything is moving to hand-held platforms. More patients are being seen by more clinicians, so more readings need to be done and there’s a time factor there. The ability to read on a portable hand-held device is very important.”

Myers’ work has had other positive benefits. The standards she devised for accurate imaging not only have helped doctors to better detect various types of cancers, but have helped determine whether tumors are getting smaller and whether cancer drugs are working. When those drugs are experimental and in clinical testing, such positive imaging results can help speed approval of new lifesaving medicines.

Myers said that her aim is not to engage in “ivory tower” research, but to come up with better ways to assess and measure the accuracy of images to improve health care and to “make a fundamental and lasting contribution.”

“It’s really important that we can precisely measure image quality to ensure better patient treatment,” she said. “We are making sure imaging devices work better and that the people who read the images are able to do so more accurately.”