Know Labs Inc (KNW)

[VoyagerSphinx44]

Between 2005 and 2018, the FDA cleared several CGM devices with a wide range of MARDs: 17.2%, 13.6%, 18.3%, and 8.7%-9.14%.

https://link.springer.com/article/10.1007/s41745-022-00348-3

The decision to clear a medical device depends on a variety of factors including safety, efficacy, and overall benefit-risk profile. If a new CGM demonstrates substantial advantages despite a slightly higher MARD, it could still be favorably reviewed.

In my opinion, the non-invasiveness, lack of consumables, and overall lower cost of the KNOW Labs device, along with consistent MARDs in the 11-12% range, makes it highly likely to receive FDA clearance in the near future.