Medical risk assessment firm Semler Scientific has received 510(k) approval from the US Food and Drug Administration (FDA) for its next generation peripheral artery disease (PAD) testing system.
Featuring convenience and easy to use characteristics, the new system is compatible with electronic medical record systems for easy accessibility of data.
Semler Scientific CEO Doug Murphy-Chutorian said: "It is our intention to make this Semler product the standard of care approach to diagnosing vascular disease.
"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."
Semler noted that it has designed the system to fulfill the needs of its growing customer base of insurance plans and integrated healthcare delivery networks.
The company plans to make the system available for customers later this year.
Semler develops and markets patented products that allow healthcare providers to monitor patients and evaluate chronic diseases.
Its first patented and FDA-cleared product is FloChec, which is used in the office setting to allow providers to measure arterial blood flow in the extremities. It can be used by internists and primary care physicians.