Tag: glucose sensor
In brief: PAP recall, indie outlook, OTC sensor, Kalogon hire
October 6, 2026HME News Staff
WASHINGTON – BMC Medical retrospectively reported to the U.S. Food and Drug Administration (FDA) a recall of 20,160 Luna G3 APAP devices (model LG3600) distributed in the United States due to a firmware defect, the agency has reported.
The FDA has classified it as a Class I recall (FDA Recall Number: Z-2979-2026).
BMC has identified that the firmware version G3-2.00.76 with configuration G3 A20-31.cfg that is installed on these Luna devices contained a debug code. The company conducted...
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...