The privately held Indiana-based device firm has accelerated its 510(k)-clearance output this year, leading all firms with 19 in the third quarter, and pulling neck-and-neck with perennial leader Medtronic for 2017. Overall, FDA remains relatively steady on 510(k) volumes and is maintaining its accelerated pace of novel-device approvals.

Four year old Luminex appears to be in the right place at the right time, but it faces increasing competition in a confusing field. The company has, in only a few short years, launched two generations of products, completed a successful IPO, and captured the attention of life scientists, who are scrambling for inexpensive, fast tools that can do genetic and proteomic analysis. Luminex has a simple-to-use multiplexing platform, which is flexible and inexpensive enough to be easily adapted to fields as diverse as genomics and clinical diagnostics.