Biolinq's Glucose Range Monitor (GRM)

On 23 September, 2025, the FDA published DEN240080:

On 25 September, 2025, Biolinq published a press release:

The FDA assigned a new product code: SFU

The FDA also assigned a new regulation: 21 CFR 862.1359 (not yet published in the eCFR database as of this writing).

Here are few highlights with comments:

• Sold by prescription - A purchase will require a physician to prescribe. At the time of a commercial launch, the product will not have reimbursement.
• Purchasers must be at least 22 years old.
• The FDA have assigned Special Controls.
• The TBD product must not be used to make therapy decisions.

The Biolinq device and its accessories, including software, phone compatibility, etc. are not disclosed.