Semler’s Next Generation PAD Testing System Gets FDA Nod

Semler Scientific said Thursday that its next-generation peripheral artery disease testing system has won FDA 510(k) clearance. The system is easy to use and compatible with electronic medical record systems, allowing for efficient access to data, the Oregon devicemaker said.

The testing system was developed to meet the needs of Semler’s expanding customer base of insurance plans and integrated healthcare delivery networks.  It will be launched later this year, the company said.

The PAD testing system marks Semler’s second FDA-cleared product. The first, FloChec, is a blood flow in-office test cleared in 2010. — Jason Scott