03.19.15
Portland, Ore.-based Semler Scientific Inc., a medical risk assessment company that also makes products for monitoring patients and evaluating chronic diseases, has received 510(k) marketing clearance from the U.S. Food and Drug Administration for its next generation peripheral artery disease (PAD) testing system.
Peripheral artery disease (PAD) is a disease in which plaque or fatty deposits build up in the leg arteries limiting blood flow. Published studies have shown that persons with PAD are four times more likely to die of heart attack, and two-three times more likely to die of stroke, yet more than 50 percent of people with the disease are undiagnosed.
The updated system is compatible with electronic medical record systems for what the company characterizes as easy accessibility of data. It was designed to fit the needs of Semler’s growing customer base of insurance plans and integrated healthcare delivery networks. The clearance allows enhanced marketing labeling and messaging to describe the benefits of working with Semler’s disease risk assessment tools.
Semler expects to launch the system later this year.
“It is our intention to make this Semler product the standard of care approach to diagnosing vascular disease,” said Doug Murphy-Chutorian, M.D., CEO of Semler. “We have incorporated product features that we believe broaden the appeal of this Semler system especially to healthcare insurance plans and integrated healthcare delivery systems interested in population health and wellness.”
Peripheral artery disease (PAD) is a disease in which plaque or fatty deposits build up in the leg arteries limiting blood flow. Published studies have shown that persons with PAD are four times more likely to die of heart attack, and two-three times more likely to die of stroke, yet more than 50 percent of people with the disease are undiagnosed.
The updated system is compatible with electronic medical record systems for what the company characterizes as easy accessibility of data. It was designed to fit the needs of Semler’s growing customer base of insurance plans and integrated healthcare delivery networks. The clearance allows enhanced marketing labeling and messaging to describe the benefits of working with Semler’s disease risk assessment tools.
Semler expects to launch the system later this year.
“It is our intention to make this Semler product the standard of care approach to diagnosing vascular disease,” said Doug Murphy-Chutorian, M.D., CEO of Semler. “We have incorporated product features that we believe broaden the appeal of this Semler system especially to healthcare insurance plans and integrated healthcare delivery systems interested in population health and wellness.”