Tag: Food & Drug Administration (FDA)
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...
Aurie announces authorization, appointments
May 11, 2026HME News Staff
SYRACUSE, N.Y. – Aurie has announced that the Aurie Reusable No-Touch Intermittent Catheter System has been granted marketing authorization from the U.S. Food and Drug Administration (FDA) through the Class II De Novo pathway. The company says the authorization establishes the product as the first ever reusable intermittent urinary catheter system and creates a new device classification in an industry that has exclusively relied on single-use catheters for decades. The Aurie System is slated...
LiViliti Health Products receives FDA clearance for CPAP sanitizer
May 4, 2026HME News Staff
SARASOTA, Fla. – LiViliti Health Products has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Paptizer 360. Classified as a Class II Respiratory Accessory Microbial Reduction Device, the Paptizer 360 provides a supplemental, at-home bacterial reduction process on compatible CPAP equipment. "This clearance marks a significant milestone for LiViliti as we continue to provide users with scientifically validated tools for their respiratory health," said...
FDA seeks med tech innovation to strengthen home care
April 14, 2026HME News Staff
WASHINGTON – The U.S. Food and Drug Administration (FDA) has launched the Reducing Readmissions through Device Innovation for the Home (READI-Home) Innovation Challenge to accelerate patient access to medical device technologies aimed at reducing hospital readmission. As part of the FDA’s Center for Devices and Radiological Health’s (CDRH) Home as a Health Care Hub Initiative, the FDA invites innovators to pursue potential participation in the challenge by submitting proposed solutions...
LivaNova receives FDA premarket approval for CPAP alternative
March 23, 2026HME News Staff
LONDON – LivaNova has announced that the U.S. Food & Drug Administration (FDA) has granted premarket approval (PMA) for the aura6000 System for the treatment of adult patients with moderate to severe obstructive sleep apnea (OSA). The system uses proximal hypoglossal nerve stimulation (p-HGNS), a differentiated neurostimulation modality, to treat OSA in patients with an apnea-hypopnea index (AHI) between 15 and 65 and who have failed, do not tolerate or are ineligible for first-line therapies,...
Dexcom issues correction for G6 software
January 5, 2026HME News Staff
WASHINGTON – Dexcom has issued a correction for Dexcom G6 and G6 Pro Software due to an identified bug that can cause the app to terminate unexpectedly, according to the U.S. Food and Drug Administration (FDA). As a result of the bug, the user may not receive estimated glucose values, alarms or alerts. If a user is unaware that the app has terminated, there is potential for missed detection of a high blood sugar (hyperglycemic) or...
Sanofi seeks expanded reach for diabetes drug
January 5, 2026HME News Staff
PARIS – Sanofi has announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review the supplemental biologic license application (sBLA) for Tzield (teplizumab-mzwv) to expand the current age indication from eight years and above to as young as one year old and above to delay the onset of stage 3 Type 1 diabetes (T1D) in patients diagnosed with stage 2 T1D. The company says the sBLA is supported by the positive interim one-year data...
Philips removes certain DreamStation devices
September 15, 2025HME News Staff
WASHINGTON – Philips Respironics has removed certain DreamStation devices due to programming errors that can result in failed therapy modes, according to the U.S. Food and Drug Administration.
The affected devices are:
DreamStation Auto CPAP UDSX500S11F 00606959423314
DreamStation Auto BiPAP UDSX700S11F 00606959423338
DreamStation Auto CPAP UFRX500S14 00606959455045
Reason for recall
Philips Respironics is recalling certain DreamStation...