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Know Labs unveils wearable, non-invasive CGM set for FDA submission

February 27, 2024 By Sean Whooley

Know Labs KnowU non-invasive blood glucose monitor rendering
A rendering of the KnowU non-invasive glucose monitor. [Image courtesy of Know Labs]
Know Labs (NYSE:KNW) today unveiled KnowU, its wearable, non-invasive continuous glucose monitor (CGM) system.

Seattle-based Know Labs first announced its initial prototype last June. It says KnowU is the result of an accelerated development process over the past eight months. The system incorporates the sensor developed by the company that it plans to submit for FDA clearance.

Know Labs tested its proprietary sensor technology in a lab setting and incorporated it into the prototype for stability outside the lab. Now, it offers the sensor in what it considers a miniaturized and wearable form. That sensor utilizes the company’s proprietary Bio-RFID technology. It uses spectroscopy to direct electromagnetic energy through a substance or material. Through this, it can capture a unique molecular signature. The technology integrates into wearable, mobile or bench-top form factors.

The new sensor can be worn with an adhesive, allowing the user to clip the sensor on and off, or on the wrist or forearm with a strap. Significantly smaller and lighter than the prototype, the device includes onboard computing power and built-in machine learning. It also eliminates costly disposables, has a rechargeable battery and an easy-to-use companion mobile app.

Know Labs said it wants to deliver the world’s first non-invasive blood glucose monitor. Notably, the FDA warned about using non-invasive devices like smartwatches or rings for this purpose right now. To date, none have marketing authorization in the U.S. The company said it is preparing for FDA clinical trials.

“The prevalence of diabetes is growing globally at an alarming rate. Millions of people face significant barriers in accessing the technology and treatment they need to effectively manage their diabetes,” said Ron Erickson, CEO and chair at Know Labs. “Know Labs is committed to delivering an accessible, affordable, and accurate solution that improves the current standard of care and enhances the quality of life for those living with diabetes. KnowU brings us closer to a future where equitable care in diabetes management will become a reality.”

Filed Under: Business/Financial News, Diabetes, Drug-Device Combinations, Featured, Patient Monitoring, Technology Tagged With: Know Labs

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About Sean Whooley

Sean Whooley is an associate editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at swhooley@wtwhmedia.com.

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