US FDA approves Semler Scientific’s next generation PAD testing system
The US Food and Drug Administration (FDA) has granted 510(k) marketing clearance for Semler Scientific’s next generation peripheral artery disease (PAD) testing system.
The next generation system features convenience and ease of use characteristics along with compatibility to electronic medical record systems for easy accessibility of data. The system 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.
The company expects to launch this next generation 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, chief executive officer 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% of people with the disease are undiagnosed. Preventative healthcare like cessation of tobacco smoking and regular exercise may lower the risks associated with PAD.
Semler Scientific, Inc. is an emerging medical risk-assessment company. Its mission is to develop, manufacture and market patented products that assist healthcare providers in monitoring patients and evaluating chronic diseases.