GlucoSet announced today on social media that it received FDA breakthrough device designation for its glucose monitoring technology.
The company took to LinkedIn to share: “GlucoSet just received breakthrough device designation from the FDA! We’ve been pursuing this for a year and a half. Landing it puts us on the fastest possible path to U.S. revenue.”
Norway-based GlucoSet developed its biosensor system with a hydrogel matrix incorporated with a glucose-binding molecule. The gel contracts at rising glucose concentrations as a consequence of glucose-induced cross-binding of the molecules. Its hydrogel is fabricated at the tip of an opticla fiber and the whole sensor is covered witha semipermeable coating.
Changes in glucose concentration cause the volume of the gel — measured by an interferometric technique — to change, causing its diameter to change accordingly.
GlucoSet aims to address elevated blood glucose due to critical illness in intensive care unit (ICU) patients. The company says that most ICUs that focus on blood glucose control either use inaccurate point-of-care glucometers or accurate and infrequent or time-consuming blood-gas analyses.
As an alternative, GlucoSet says its sensors deliver high accuracy, rapid measurements and high sensitivity in the hypoglycemic range. The company aims to develop offerings that fit into existing workflows of nurses and physicians.
The company expects breakthrough designation to expedite its FDA review and Medicare coverage within its go-to-market plan.
“We previously aligned with the FDA to enter through the standard 510(k) pathway – uncommon for a first-in-category device, but it cuts years off our timeline,” the company wrote. “Combined with breakthrough designation, we now have the fastest possible path to market for a novel medical device. Clinicians regularly tell us our device is urgently needed. Now the FDA has confirmed it, cleared the path, and put us on a fast-track that matches the stakes.”
