Israeli medical device company Integrity Applications has begun the process with the FDA to bring its noninvasive glucose monitoring device, GlucoTrack, to the United States.
GlucoTrack allows users to monitor their blood glucose level without drawing blood. The user wears a clip on his or her ear, and GlucoTrack uses a combination of sensors to determine blood glucose level, then sends the data to handheld device about the size of a smartphone. The ear clip still has to be calibrated every six months, and the calibration presumably requires drawing blood.
"GlucoTrack performs three independent measurements simultaneously, using thermal, ultrasound, and electromagnetic technologies," the company explains in the FAQ section of its website. "The results are weighted, using a patented, unique algorithm to provide a reading which is displayed on a color touch screen of the device by large, clear digits. The result is announced verbally as well, allowing visually impaired users [to use the device as well]."
The technology already has a CE Mark and is available in some other countries, but bringing the technology to the United States will take some time. Integrity Applications has filed pre-submission documents, asking the FDA for feedback on its plans for US-based clinical trials. The company will need to complete those trials before actually submitting the technology for FDA clearance.
According to a statement from Integrity Applications, the company is "currently in advanced discussions with a well-known hospital and university to conduct such clinical trials," which the company hopes to begin in early 2016.
Integrity Applications is a publicly traded company that has raised about $22.6 million in funding, the latest of which was a post-IPO equity round in January, when the company raised $8.5 million.
Noninvasive glucose monitoring is an attractive but daunting proposition, and a mainstream, accurate version of it has yet to emerge, though there have been some high-profile attempts.
Probably the most well-known noninvasive glucose monitoring effort is underway at Google, which partnered with Novartis recently to continue development of a glucose-sensing contact lens. Another contact lens attempt comes from a startup called Madella Health, which was founded by a Thiel Fellow. Both organizations are focusing on designing these offerings specifically for people with diabetes. And Sano Intelligence, a stealth-mode company that raised $10.25 million in funding from True Ventures and Intel Capital in June, is also reportedly working on a noninvasive glucose monitoring device, though with a general wellness focus, rather than a focus on diabetes.