SPARK Central incubator tenant Hygieia, Inc. receives 510(k) clearance from FDA
Hygieia, Inc., a tenant at the SPARK Central business incubator, recently received official 510(k) clearance from the US Food and Drug Administration (FDA) for its BaseSens I Blood Glucose Monitoring System. Hygieia, Inc. is a start‐up that is developing a proprietary hybrid medical device that combines state‐of‐the‐art blood glucose monitoring capability with a physician‐initiated self‐adjusting insulin dose calculator.
Of the news, Eran Bashan, PhD., Co‐founder and CEO of HYGIEIA, Inc. said, “First and foremost, we are pleased to announce achievement of this milestone to our current and potential investors. Along with other significant accomplishments, the granting of the FDA 510(k) clearance demonstrates that HYGIEIA is on track with its business plan. The longer range vision to revolutionize diabetes careis advanced by another mile.”
Congratulations on the exciting progress and achievement!