The company aims to begin the Food and Drug Administration (FDA) pre-approval process in 2022.
The company says it is actively working to commercialize the UBand, and the newer KnowU product shouldn’t be far behind.
Know Labs leadership tells DiabetesMine it’s too early to talk potential pricing, but they are considering a subscription model where you’d pay a monthly fee to access data analytics and other yet-to-be determined services from Know Labs.
While Know Labs has largely been off the grid in “stealth mode,” they’re now starting to make headlines with early data and these prototype designs. That also means they’re looking for investors to support their regulatory and manufacturing efforts.
“We know that not all people with diabetes are looking for a wearable continuous glucose monitoring device to manage their diabetes. Some simply want to replace the painful, inconvenient, and expensive fingersticks they currently rely on,” CEO Phil Bosua said in a statement. “The Bio-RFID sensor we currently use for our internal product testing fits in your pocket and is ready for final use. So, we decided to create the KnowU as a portable, affordable, and convenient alternative requiring no disposable items, such as test strips and lancets.”
There’s been a longstanding debate over whether it’s really possible to create an effective and accurate noninvasive glucose monitoring system. Over the years, many have tried and failed, including Google Verily, with their failed idea for glucose-sensing contact lenses.
In the early 2000s, one product called the GlucoWatch actually made it through the FDA approval, but it was later pulled from the market because the device was burning people’s skin.
In June 2021, a 47-page article on this topic was published in the Journal of Diabetes Science and Technology, written by experts across the world associated with the Diabetes Technology Society led by Dr. David Klonoff. It constitutes the most comprehensive resource on the topic that, for the first time, classified bloodless monitoring products into three categories:
“A few of these products have been cleared by the FDA and many other products might eventually be cleared by the FDA if they can overcome technical hurdles,” said Kevin Nguyen, bioengineering administrator at the Diabetes Technology Society.
Overcoming technical hurdles is of course the rub. We at DiabetesMine are rooting for Know Labs and all of their competitors who aim to improve life with diabetes by finally removing needles from the equation for good.
This content was originally published here.