Tag: Food & Drug Administration (FDA)
BMC Medical recalls more than 20K Luna APAP devices due to firmware defect
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...
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...
Wandercraft announces FDA clearance for personal exoskeleton
August 12, 2026HME News Staff
NEW YORK – Wandercraft has today that the U.S. Food and Drug Administration (FDA) has granted clearance for Eve, its personal self-balancing exoskeleton designed to support upright mobility in everyday life. For eligible wheelchair users, the clearance opens new possibilities beyond rehabilitation, bringing hands-free upright mobility into ordinary moments, the company says. “FDA clearance of Eve marks one of the most important moments in Wandercraft’s history and a significant...
FDA updates early alert for Resmed vents
August 5, 2026HME News Staff
WASHINGTON – The U.S. Food and Drug Administration (FDA) has updated its early alert for certain Resmed Astral ventilators to a recall. “The affected products and recommendations for what to do with the devices have not changed,” the agency stated. “This recall involves correcting certain devices and does not involve removing them from where they are used or sold.” The FDA has identified the recall as the most serious type, with the potential to cause serious injury...
FDA selects Dexcom for digital health pilot
July 29, 2026HME News Staff
WASHINGTON – The U.S. Food and Drug Administration (FDA) has selected Dexcom as the first participant in its Technology-Enabled Meaningful Patient Outcomes for Digital Health Devices Pilot, or TEMPO. The pilot, conducted in partnership with the CMS Innovation Center, is designed to evaluate how digital health technologies perform in real-world settings while expanding access to technology-enabled care for people with Medicare. The program is intended to help patients participating in CMS’s...
UPDATED: FDA issues early alert of potential issue with Resmed Astral
July 16, 2026HME News Staff
WASHINGTON - The U.S. Food and Drug Administration (FDA) on July 15 issued an early alert to notify the public of a potentially high-risk device issue with certain Resmed Astral 100 and Astral 150 ventilators.
The FDA said it is aware that Resmed has issued a voluntary Global Medical Device Correction / Field Safety Notice for its Astral 100 and Astral 150 ventilators built prior to October 2024 due to the potential of a component called a supercapacitor leaking over time. The leakage...
FDA sends warning to BMC Medical for allegedly adulterating, misbranding device
July 14, 2026HME News Staff
WASHINGTON – The U.S. Food and Drug Administration (FDA) issued a warning letter to BMC Medical, citing regulatory violations involving the company’s G3X APAP devices, which are imported into the United States by React Health (formerly 3B Medical). Through an inspection, the agency determined that BMC made significant design and software changes to a previously cleared Luna APAP device without submitting a new 510(k) premarket notification for FDA review. The newly branded G3X APAP, the...
UPDATED: Apnimed files for IPO, FDA accepts application
July 14, 2026HME News Staff
CAMBRIDGE, Mass. – Apnimed has filed for an initial public offering (IPO) with the U.S. Securities and Exchange Commission (SEC). The company has also announced the U.S. Food and Drug Administration (FDA) has accepted for review its New Drug Application filing for Oxnimbi, an oral treatment for obstructive sleep apnea (OSA).
In its Form S-1, the company acknowledges positive airway pressure (PAP) as the current standard of care for OSA, but notes many patients refuse or discontinue the treatment...
FDA gives greenlight to Dexcom OTC CGM
June 16, 2026HME News Staff
WASHINGTON – The U.S. Food and Drug Administration (FDA) has cleared for marketing the first over-the-counter (OTC) continuous glucose monitor (CGM) for children: Dexcom’s Stelo Glucose Biosensor System, an integrated CGM (iCGM) indicated for people two years of age and older who do not use insulin. The FDA previously cleared the Stelo Glucose Biosensor System OTC for individuals 18 years and older in March 2024. “Children deserve access to the best tools available to manage their...