We’re pleased this issue to publish the first of a two-part article by Eric Swanson, a pioneer in optical coherence tomography (OCT), that discusses government investment in OCT as well as the return on that investment—in terms of diagnostics, patient outcomes. and research in multiple disciplines; plus job creation, revenue generation and other economic measures (see p. 30).
This year OCT is celebrating its 20th anniversary, and since Swanson penned his article the technology has seen some interesting developments, including demonstration for the first time of the ability to reliably determine risk of pancreatic cancer, and European CE Mark approval of the first instrument to pair optical coherence tomography (OCT) with fractional flow reserve (FFR; a non-optical technology) for diagnosis and treatment of coronary artery disease.
The vitality that Swanson summarizes—and that these developments further exemplify—is also evident in my own much-less-rigorous review of the broader biophotonics market. One indicator of this vitality is regulatory activity. A quick recap of the year’s notable biophotonics regulatory news would have to include LensAR’s Food and Drug Administration (FDA) approval for use of its laser system in an entirely new laser biomedicine application: cataract surgery. And NIDEK’s receipt of 510(k) clearance for its MC-500 Vixi, the first pattern scan laser photocoagulator that allows eye surgeons to choose a color or combination of colors when treating various ocular pathologies.
Also notable is Guided Therapeutics’ receipt of Institutional Review Board approval to test its bio-optical technology in humans for a condition thought to precede esophageal cancer. More recently, the company was awarded more than half a million dollars to fund the third (and final) year of a $2.5 million grant from the National Cancer Institute for development of a fast, biophotonics based test for cervical cancer, which is undergoing FDA pre-market approval (PMA).
Speaking of PMA, what at first seemed a setback to Imaging Diagnostic Systems, Inc. could pay off in the long term: The FDA has categorized the company’s optical breast imaging system (computed tomography laser mammography, or CTLM) as a Class III device because the technology, which the company says is best described as diffuse optical tomography (DOT), is not substantially equivalent to approaches such as MRI and CT.
Editor in Chief