Semler receives 510(k) marketing clearance from FDA for next generation PAD testing system

Semler Scientific, Inc. (Nasdaq: SMLR), an emerging medical risk assessment company that develops, manufactures and markets patented products that assist healthcare providers in monitoring patients and evaluating chronic diseases, today announced receipt of 510(k) marketing clearance from the U.S. Food and Drug Administration for its 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, M.D., 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."