Tag: Over the counter
Biolinq glucose sensor receives clearance for OTC use
October 5, 2026HME News Staff
SAN DIEGO – Biolinq Incorporated has announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for over-the-counter (OTC) use of Biolinq Shine, the company’s needle-free glucose sensor designed to provide a simple, intuitive view of glucose, activity and sleep information in a single device with autonomous operation. The clearance expands access to Biolinq Shine without a prescription, marking the company’s latest regulatory milestone following FDA...
TENS device hits over-the-counter market
April 22, 2014HME News Staff
BILLINGS, Mont. - ExcelHealth's new dual-channel electrotherapy TENS device for muscle and joint pain relief is now available without a prescription. The suggested retail price for the iReliev Pain Management System is $69.95. ExcelHealth seeks distribution partners for the device, which is smaller than many cell phones and comes with batteries. The device is already available on eBay, Amazon and HealthOutfitters.com.