GE Is Latest to Make Handheld Ultrasound
By PAUL GLADER
The makers of MRI machines and CAT scanners the size of minivans are now rolling out handheld ultrasound machines just slightly larger than iPhones, hoping they'll become as commonly used as stethoscopes.
Manufacturers including General Electric Co. and Siemens AG expect doctors, nurses, paramedics—even veterinarians—to carry the devices at all times, making it handy to check for internal injuries or clues of cardiac trouble. While the images aren't as good as those produced by traditional ultrasound, the manufacturers are betting the convenience will spur their use, opening up a global market GE executives think could be worth $1 billion per year.
Paul Glader looks at a new class of ultrasound machines that are small enough to fit in a doctor's lab-coat pocket.
The proliferation of devices raises questions about whether rank-and-file medical staff can be trained to use the machines properly. It also needs to be established exactly what insurance companies will pay for.
Still, manufacturers are pushing ahead. GE just unveiled its vScan machine, which is the size of a cellphone and, with regulatory approval, will go on the market as early as Monday for less than $10,000.
Siemens is updating its Acuson P10 handheld scanner that came out in 2007 and is selling roughly 600 of them a year, a modest number. Signostics, a smaller firm from Palo Alto, Calif., released its $4,000 Signos Personal Ultrasound machine in the U.S. early last year and declined to share sales data. Other makers are making tablet-style ultrasound machines.
The handhelds threaten to displace sales in the existing $5 billion global market for laptop-sized ultrasound machines that cost as much as $50,000, as well as traditional cart-based ultrasound machines that weigh as much as refrigerators and cost as much as $250,000 apiece.
"Right now, it's the most dynamic segment within the ultrasound market," said Antonio Garcia, research manager for Frost & Sullivan's Medical Imaging Group, referring to laptops and handheld machines. His firm predicts 7.5% growth in the portable ultrasound market, which produced $680 million in revenue globally in 2008, compared with growth of just 1% in the overall ultrasound market.
GE Healthcare executives think the handhelds could reduce the need for tests and referrals during physical examinations, and could make health care more accessible to patients in the U.S. and in emerging markets. "Our vision is that, one day, every clinical procedure will require ultrasound the way everything requires a stethoscope today," said Omar Ishrak, president and CEO for clinical systems at GE Healthcare.
Ultrasound machines are now available in a handheld size.
Jerry Westerfield, a radiologist in Russell Springs, Ky., already uses laptop-sized scanners to help him locate veins for an intravenous line or to place a stent in an artery. A handheld device would "save me tons of time and fewer sticks," of the needle, he said. But he also sees risks to spreading around cheaper, portable scanners in emergency medicine or bedside care. "You have to be trained to use it," Dr. Westerfield said.
Ultrasound technicians currently attend two- and four-year college programs or are trained at hospitals. Some doctors and nurses also get sonography training. States don't require a license, although the American Registry for Diagnostic Medical Sonography and other groups provide certification. Mr. Ishrak of GE Healthcare says the company is working with groups to set training guidelines.
"We want to do it responsibly," he says. The company will start selling vScan machines as early as Monday to some doctors and hospitals for early testing.
Charlotte Henningsen, chair of sonography at Florida Hospital College of Health Sciences in Orlando and president of the Society of Diagnostic Medical Sonography, has tried the vScan and said it will be useful as a companion to the stethoscope. But she warned it should only be used by trained staff. For example, an EMT with marginal sonography skills might scan a patient for internal injuries, spotting some and missing others.
Acquiring and interpreting ultrasound images requires knowledge of cross-sectional anatomy and lots of training, says David Jaslow, chief of emergency medicine at Albert Einstein Healthcare Network in Philadelphia. Still, Dr. Jaslow, a specialist in disaster relief, thinks the devices will "be the most significant technological advancement" to diagnose a variety of conditions in a disaster settings like earthquakes.
At least two hospitals are training staff to use the Siemens Acuson P10 and plan to publish papers on the results. Pamela Wickkiser, radiology director at Humboldt General Hospital in Winnemucca, Nev., has paramedics using the devices in ambulances on a practice basis. "They are actually picking the skills up pretty well," she says. "For us, being so rural out here, it would be a big plus to get this kind of information pre-hospital."
Bruce Kimura, a cardiologist at Scripps Mercy Hospital in San Diego who is testing several devices, says the idea they could replace stethoscopes "is not crazy. It could happen." Two years ago, he scanned one patient's neck with the P10 and found her carotid arteries were clogged. The exam took a few minutes in the doctor's office and may have prevented a future stroke.
Ultrasound imaging came about after World War II and borrows technology from sonar equipment for ships at sea. The device emits sound and detects returning echoes, producing computerized images of body organs. Doctors like the technology because it isn't invasive, doesn't use radiation and provides images in real time.
The poorer image quality of handheld ultrasound scanners and questions about insurance reimbursement could limit their growth. Insurers have already been lowering reimbursement rates for other scans, and GE doesn't yet know whether use of its vScan will be reimbursable. "Is there a reimbursement code for this? No there's not," said Dr. Kimura. "That's a problem."
A handheld that meets certain qualifications, including the ability to permanently record images with measurements, "would be paid at the same level as other diagnostic ultrasounds," said Tammy Arnold, a spokeswoman at medical insurer Aetna. Those that don't would be considered part of a physical examination and wouldn't be separately payable.
A number of companies including Toshiba Medical Systems Corp. and Hitachi Medical Corp. make laptop-sized ultrasound machines but aren't planning to offer handhelds yet. Philips Medical Systems Americas Inc. offered an OptiGo handheld ultrasound device nearly 10 years ago, but pulled it from the market because of weak sales. Executives there are skeptical of the image quality and whether there's even a need for something more portable than a laptop.
Others believe it's only a question of time. George Stagakis, head purchasing agent for the Children's Hospital of Wisconsin in Milwaukee, says there will definitely be a market. At a recent imaging show in Chicago, he was looking to buy handheld devices doctors can use to check for heartbeats and fluid around the heart. Obstetricians, he said, would just roll the cost into their normal fee.
Write to Paul Glader at email@example.com