Tag: warning letter
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...
In brief: Apnimed files for IPO, BMC receives warning, Quality Biomed makes buy
July 10, 2026HME News Staff
CAMBRIDGE, Mass. – Apnimed has filed for an initial public offering (IPO) and 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 due to issues such as discomfort, pressure intolerance and...
CPAP cleaners get warning
September 3, 2024HME News Staff
WASHINGTON – Four companies have received warning letters from the U.S. Food and Drug Administration for selling CPAP cleaning products without marketing clearance or approval, violating the Federal Food, Drug and Cosmetic Act.
The companies are:
Shenzhen Moyeah Intelligent Life Technology Co. for 10 different products, including the CPAP Cleaner With Sanitizer Bag Ozone Disinfector C966 or MOYEAH Brand New CPAP Sanitizer Bag Ozone Disinfector C966|Latest Technology.
Natures...